Dec. 2, 2008 The surge of generic drugs to hit
the market in the last few years and the plunge in prices led by Walmart
has attracted many senior citizens to these prescription drugs. Yet, for
many, there has been a nagging doubt of their potency how could a drug
that costs only $4 per month do the same thing as the one that was
costing $80 a month.
A new scientific study tried to find the answer and
has concluded that contrary to the perception of some patients and even
physicians, there is no evidence that brand-name drugs are clinically
superior to their generic counterparts.
A generic drug is identical, or bioequivalent to a
brand name drug in dosage form, safety, strength, route of
administration, quality, performance characteristics and intended use,
says the Food and Drug Administration (FDA) in the opening sentence on
its Web page for generic drugs. Still doubts have persisted.
This research, in the December 3 issue of the
Journal of the American Medical Association (JAMA), examined studies
comparing the effectiveness of generic vs. brand-name drugs for treating
cardiovascular diseases.
Offering tools to find low-cost generic drugs, adhere
to drug regimens and increase consumer choice
Sept. 18, 2008 The skyrocketing cost of health
care seems to be slowing a bit and an obvious contributor is lower cost
that senior citizens and others are finding for prescription drugs
generic drugs, in particular. A driving force in this trend are pharmacy
benefit managers, which can increase their profits by helping consumers
find lower priced drugs.
Read
more...
Generic Statin Use Jumps 8% to 53%
After generic for Zocor was introduced, Express Scripts
combined incentives with "an advanced and aggressive
communications program" to increase the ratio of consumers
who used generic statin from 8% to 53.2%.
"The problem of rising prescription drug costs has
emerged as a critical policy issue, straining the budgets of patients
and public/private insurers and directly contributing to adverse health
outcomes by reducing adherence to important medications. The primary
drivers of elevated drug costs are brand-name drugs, which are sold at
high prices during a period of patent protection and market exclusivity
after approval by the FDA," the authors write.
To control spending, many payers and clinicians
have encouraged substitution of inexpensive bioequivalent generic
versions of these drugs after the brand-name manufacturer's market
exclusivity period ends.
Some patients and physicians, the researchers say,
have expressed concern that generic drugs may not be equivalent in their
effectiveness.
"Brand-name manufacturers have suggested that
generic drugs may be less effective and safe than their brand-name
counterparts. Anecdotes have appeared in the lay press raising doubts
about the efficacy and safety of certain generic drugs," they note.
Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham
and Women's Hospital and Harvard Medical School, Boston, and colleagues
assessed the clinical differences resulting from the use of generic
medications or brand-name drugs used primarily to treat cardiovascular
disease, which as a group make up the largest portion of outpatient
prescription drug spending.
The researchers conducted a meta-analysis on
studies on this subject published from 1984 to August 2008, and to
determine the expert opinion on the subject of generic substitution,
also reviewed the content of editorials published during this time.
The researchers identified 47 articles for detailed
analysis, covering nine different subclasses of cardiovascular drugs, of
which 38 (81 percent) were randomized controlled trials (RCTs).
Clinical equivalence was noted in -
● 7 of 7 RCTs (100 percent) of beta-blockers,
● 10 of 11 RCTs (91 percent) of diuretics,
● 5 of 7 RCTs (71 percent) of calcium-channel blockers,
● 3 of 3 RCTs (100 percent) of antiplatelet agents,
● 2 of 2 RCTs (100 percent) of statins,
● 1 of 1 RCT (100 percent) of angiotensin-converting enzyme
(ACE) inhibitors, and
● 1 of 1 RCT (100 percent) of alpha-blockers.
Among narrow therapeutic index drugs (NTI; drugs
whose effective doses and toxic doses are separated by a small
difference in plasma concentration), clinical equivalence was reported
in -
● 1 1 of 1 RCT (100 percent) of class 1 anti-arrhythmic agents and
● 1 5 of 5 RCTs (100 percent) of warfarin.
Forty-three editorials and commentaries were
identified as meeting study criteria. Of these editorials, 23 (53
percent) expressed a negative view of the interchangeability of generic
drugs compared with 12 (28 percent) that encouraged substitution of
generic drugs (the remaining 8 did not reach a conclusion on
interchangeability).
Among editorials addressing NTI drugs specifically,
12 (67 percent) expressed a negative view while only 4 (22 percent)
supported generic drug substitution.
"One explanation for this discordance between the
data and editorial opinion is that commentaries may be more likely to
highlight physicians' concerns based on anecdotal experience or other
nonclinical trial settings.
Another possible explanation is that the
conclusions may be skewed by financial relationships of editorialists
with brand-name pharmaceutical companies, which are not always
disclosed. Approximately half of the trials in our sample (23/47, 49
percent), and nearly all of the editorials and commentaries, did not
identify sources of funding," the researchers write.
The researchers also reported, "...we identified
numerous studies that evaluated differences in clinical outcomes with
generic and brand-name medications. Our results suggest that it is
reasonable for physicians and patients to rely on FDA bioequivalence
rating as a proxy for clinical equivalence among a number of important
cardiovascular drugs, even in higher-risk contexts such as the NTI drug
warfarin.
These findings also support the use of formulary
designs aimed at stimulating appropriate generic drug use. To limit
unfounded distrust of generic medications, popular media and scientific
journals could choose to be more selective about publishing perspective
pieces based on anecdotal evidence of diminished clinical efficacy or
greater risk of adverse effects with generic medications.
Such publications may enhance barriers to
appropriate generic drug use that increase unnecessary spending without
improving clinical outcomes."
Dec. 2, 2008 The surge of generic drugs to hit
the market in the last few years and the plunge in prices led by Walmart
has attracted many senior citizens to these prescription drugs. Yet, for
many, there has been a nagging doubt of their potency how could a drug
that costs only $4 per month do the same thing as the one that was
costing $80 a month.