Facts about the
Opioid Epidemic and New Data [from a concerned
provider]:
In my opinion, two major reasons
why the opioid problem got so out of hand relates to the
corporate influence of both unethical over-promotion for
sales and profit on one end, and the lack of regulatory
over-sight to protect the public on the other.
Purdue Pharma continues to
distribute material to doctors promoting OxyContin and
other opioids NON-SELECTIVELY [well beyond cancer and
other types of severe intractable tissue pain] for a
broad range of chronic non-cancer pain disorders
regardless of diagnosis. This sends a dangerous message
which encourages clinical inertia and results in poor
outcomes, such as when opioids are given inappropriately
for chronic pain generated by psychological disorders
[especially if masquerading with inaccurate
musculoskeletal or other somatic diagnoses].
Furthermore, the efficacy and safety of long-term opioid
therapy has NEVER been documented by a multitude of
current research studies, which often indicate the
opposite findings.
Regardless of the above, in a
marketing booklet for providers from Purdue's "Partners
Against Pain" series entitled "Clinical Issues in Opioid
Prescribing: Considerations for the Practitioner in the
Use of Opioids in Managing Moderate to Severe Pain"
[2005], it states that the "use of controlled-release
opioids is often NOT DEPENDENT ON A SPECIFIC DISEASE
STATE, but is based on the severity and chronicity of
pain". This contradicts the impression of experienced
clinicians, as well as statements from the Federation of
State Medical Boards of the United States [2004] which
notes that the prescribing of a controlled substance for
pain "should be based on a DIAGNOSIS---and whether the
drug used is APPROPRIATE for the diagnosis, as well as
improvement in functioning and/or quality of life." This
cavalier attitude of the drug company regarding the
non-selective use of opioids, especially when adopted by
primary care providers with insufficient time to
adequately evaluate difficult patients, underlies opioid
overuse and the excessive availability of opioids which
has contributed to many of the adverse and tragic events
that have occurred over the last few years.
The same brochure states that "with
pure opioid analgesics, there is NO DEFINED MAXIMUM
DOSE; the CEILING to analgesic effectiveness is imposed
ONLY BY SIDE EFFECTS, the most serious of which is
RESPIRATORY DEPRESSION" and that therapy should be
adjusted based upon "the PATIENT�S OWN REPORTS OF PAIN
and side effects".These
statements, when appplied to chronic non-cancer
patients, facilitate the possibilities of both overdose
and the act of prescribing opiate drugs to addicts and
abusers.
Furthermore, they contradict the
conclusion of a major review article on opioid therapy
for chronic pain which stated the following: "whereas it
was previously thought that unlimited dose escalation
was at least safe, evidence now suggests that prolonged,
high-dose opioid therapy may be neither safe or
effective." [Ballantyne JC, Mao J: Opioid therapy for
chronic pain. The New England Journal of Medicine
2003;349:1943-53.].
It seems that the advice that
Purdue is giving to doctors are 'prescriptions' not only
for a great deal more opioids for patients, but also
'prescriptions' which may predispose to addiction,
abuse, overdose and death, and which unfortunately have
already occurred on a large scale.
The failure of post-marketing
over-sight of safety issues by the FDA, which has been
contaminated by corporate influence, has greatly
amplified the problem, in spite of criticism from many
parties. In a recent report by the Institute of Medicine
on drug safety in the New England Journal of Medicine,
some of the conclusions in regard to drug-safety
included: "the negotiations between industry and the FDA
about performance goals have contributed to the
perception that the FDA's client is industry rather than
the public." Furthermore, the article goes on to state
that "in 2006, the Government Accountability Office
found that the "FDA lacks clear and effective processes
for making decisions about, and providing management
oversight of, postmarket safety issues." [Psaty BM et.
al. Institute of Medicine on Drug Safety. The New
England Journal of Medicine 2006;355;17:1753-55].
The most comprehensive review of
the problem appeared in the journal Pain Physician
(2006;9,287-321):�Prescription Drug Abuse: What is being
done to address this New Drug Epidemic?� by Laxmaiah
Manchikanti, MD. CDC and DEA data taken from this review
include the following:
From 1997 to 2004, there were
marked increases in sales, therapeutic use,
and non-medical use of
oxycodone/OxyContin, as well as in overall
opioid-related deaths. During these
years there was:
[1] a 556% increase in the sales
of oxycodone,
[2] a 500% increase in therapeutic
grams of oxycodone used,
[3] a 568% increase in the
non-medical use of OxyContin [comment- this most likely
relates not only to widespread availability and
increased recreational use,
especially among young people, but
to the behavioral characteristics of a
growing population of newly-created
addicts, as well as to diversion and sale of the drugs
by those motivated for economic gain, and a rising
volume of drug-related crime].
[4] a 129% increase in opioid-related
deaths [without heroin or cocaine]:
from 1942 deaths in 1999, to 4451
deaths in 2002 [the last year this was
calculated].
http://www.painphysicianjournal.com/2006/october/2006;9;287-321.pdf
If one then extrapolates the 4451
figure in 2002 over the next four
years to the end of 2006 [which is
probably an underestimate], the total
number of deaths from opioids over
the five year period of 2002-2006 may be at
least a staggering 22,255 [4451 x
5], a number that far exceeds the combined
American fatalities of 9/11 and the
Iraq War!
In addition to the CDC data
documented in the above review, other reports from this
institution indicate how extensive a problem this has
become in both rural and metropolitan areas of the U.S:
[1] A study from Utah reveals the
tremendous percent increase in opioid-related deaths
from various opioids between the period 1991-98 compared
to 1999-2003. These increases include: hydrocodone
+328%, oxycodone +1676%, fentanyl +2060%, and methadone
+1358% [MMWR Jan. 21, 2005/54;33-36].
[2] A just-released article from
the CDC reports on the increase in opioid analgesic
drug-abuse deaths in 28 metropolitan areas in the U.S.
from 1997-2002. The total for all prescription opioid
reports increased by +96.6%, with methadone, oxycodone
and unspecified opioids accounting for 74.3% of the
increase. Reports of oxycodone deaths increased +727.8%
over these years [from 72 to 596 reports]. The article
states that "dramatic increases in the availability of
such opioids have made their abuse a major, growing
problem."
[Paulozzi LJ. Opioid analgesic
involvement in drug abuse deaths in American
metropolitan areas. Am J Public Health. 2006
Oct;96:1755-57.]
The handwriting is already on the
wall as confirmed by many sources. These latest reports
make it clear that if powerful brain-active opioids with
high street value like Oxycontin (oxycodone) are given
to the wrong people, bad things will inevitably happen.
The public has a right to be well-informed and know all
the facts, because tragically it is they who have paid
the highest price.
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