How Government Enables the Opioid
Epidemic and Tax-Payers Help Fund It
March 16, 2016
Story at-a-glance
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A clueless government seeks "treatment" for the
opioid epidemic without addressing irresponsible
prescribing and drug industry marketing, and high
level financial conflicts of interest
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Opioid makers have targeted taxpayer supported
programs like Medicaid, Medicare and military
programs to supply them rich opioid revenues
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Opioids have been promoted for uses once not
accepted because of the drug class’ dangers and
addiction potential. As users can no longer get or
afford pills, they turn to heroin
By Dr. Mercola
We are in the middle of an
opioid and heroin epidemic, which is killing ever increasing
numbers of Americans at an astonishing rate.
In 2014, almost 30,000 people died from heroin and opioids
(also called narcotic prescription painkillers), exceeding those
who died from car accidents during the same year, says the
Centers for Disease Control and Prevention (CDC).1
Prescriptions for opioids have risen by 300 percent over the
past 10 years and fed the heroin epidemic as the tolerance of
opioid addicts surpasses their allotted prescription dosage
and/or they are no longer allowed to refill their prescription.
In April of 2015, the U.S. Drug Enforcement Administration
(DEA) also noted that "Controlled prescription drug abusers who
begin using heroin do so chiefly because of price differences.”2
Most people know there is a prescription painkiller epidemic
underway but few realize how much the government is enabling it,
how much taxpayers are subsidizing it, and how this is the root
cause of the current heroin epidemic.
Conflicts of Interest Color Pain Treatment
In February, Senator Ron Wyden (D-OR) wrote a letter to
Sylvia Burwell, the head of the Department of Health and Human
Services (HHS), about the glaring conflicts of interest at the
Interagency Pain Research Coordinating Committee, convened as
part of the Affordable Health Care Act3
to improve pain-related treatment strategies.4
Questions began to arise when members of the panel objected
to federal suggestions that doctors reduce opioid prescriptions
for chronic pain.5
According to the Associated Press, conflicts at the Interagency
Pain Research Coordinating Committee include:
“[T]wo panelists work[ing] for the Center for
Practical Bioethics, a Kansas City group which receives
funding from multiple drugmakers, including OxyContin-maker
Purdue Pharma, which donated $100,000 in 2013.
One panelist holds a chair at the center created by a
$1.5-million donation from Purdue Pharma. The other has
received more than $8,660 in speaking fees, meals, travel
accommodations and other payments from pain drugmakers ...
A third member of the panel is a director with the
U.S. Pain Foundation, a nonprofit that receives most of its
funding from drugmakers, including a $104,800 donation from
Purdue Pharma in 2014, according to IRS Records cited by
Wyden.
Two other panelists are connected to the American
Chronic Pain Association, another nonprofit that receives
substantial funding from drugmakers, including Pfizer Inc.,
AstraZeneca Plc, Teva Pharmaceuticals Industries Ltd. and
AbbVie Inc.”
Big Pharma Money Responsible for Loosening US Drug Policies
The panelists, who appear to be foxes guarding the hen house,
are not the only experts developing drug policies while taking
opioid makers’ money.
In 2009, the American Geriatrics Society changed its
guidelines to recommend "that over-the-counter pain relievers,
such as ibuprofen and naproxen, be used rarely and that doctors
instead consider prescribing opioids for all patients with
moderate to severe pain.”6
Half the panel's experts "had financial ties to opioid
companies, as paid speakers, consultants or advisers at the time
the guidelines were issued," reporter John Fauber writes.
The University of Wisconsin's Pain & Policy Studies Group
also took $2.5 million from opioid makers even as it pushed for
looser use of narcotic painkillers.7
Federal officials have also been intensely lobbied by a drug
company-funded group called IMMPACT whose stated goal is
“improving the design, execution, and interpretation of clinical
trials of treatments for pain.”8,9
For a fee that could be as high as $35,000, IMMPACT promises
to get drug company representatives into invitation-only
meetings of government officials and academic leaders, often at
elegant places, where they can lobby NIH researchers and FDA
officials one-on-one.
The public and press are not included in the meetings, which
date back to 2002. Both Purdue Pharma, which makes OxyContin,
and Janssen, which makes the opioids Duragesic and Nucynta, have
acknowledged the value of IMMPACT.10
Many Opioids Makers Rely on Taxpayer Funded Programs for Profits
According to the Office of the Inspector General (OIG) for
the HHS, spending on opioids in the Medicare system, which of
course is funded by our tax dollars, grew at a faster rate than
spending for all drugs. It writes:11
“Between 2006 and 2014, spending for commonly abused
opioids grew from $1.5 billion to $3.9 billion, an increase
of 156 percent ...
Growth in spending for these opioids outpaced both
the growth in spending for all Part D drugs (which grew 136
percent) and the growth in the number of beneficiaries
receiving Part D drugs (which grew 68 percent).12
...
The total number of beneficiaries receiving these
opioids grew by 92 percent, compared to 68 percent for all
drugs, while the average number of prescriptions for
commonly abused opioids per beneficiary grew by 20 percent,
compared to 3 percent for all drugs.”
Clearly, not only are many Medicare recipients receiving
opioids (no doubt thanks to groups like the American Geriatrics
Society) they are receiving multiple prescriptions for them.
Even more concerning is the fact that many Medicare patients
are being prescribed opioids for reasons other than cancer
pain or terminal illness, the traditional uses of these
strong medications according to published source.13
In some states over 40 percent of Medicare patients receive
opioids.14
Government Paid-For Over-Dispensing of Opioids Is Widespread
According to the OIG, thousands of pharmacies are believed to
be over-dispensing opioids within the Medicare system and likely
involved in fraud.15
At least 1,432 retail pharmacies showed questionable
activity, including 468 that had triple the average percentage
of prescriptions for commonly abused opioids.16
In the case of one pharmacy, reports the Detroit News:17
“58 percent of the prescriptions it billed to
Medicare’s program were for commonly abused opioids,
compared with the nationwide average of 6 percent. The
pharmacy billed opiate prescriptions for 93 percent of the
Medicare patients it served last year ...
Pharmacies with high percentages of prescriptions for
narcotics raise flags about potential billing for extra
drugs that are never dispensed and diverted for resale, or
otherwise used inappropriately, according to the report.”
Medicaid programs, also supported by taxpayers but
administered by states, also reveal excessive opioid use and
probable fraud.18
In 2010, 359,368 Medicaid enrollees received an opioid
prescription amounting to over 2 million prescriptions and again
suggesting many prescriptions per patient.19
In 2009, 41.4 percent of Medicaid-enrolled women filled an
opioid prescription compared with 29.1 percent of privately
insured women, offering further proof that opioid makers are
relying on public funds for their sales and profits.20
Millions of Tax Payer Dollars Used for Opioid Prescriptions
While Medicaid programs likely provide generic combinations
of the active ingredient in OxyContin, hydrocodone, to patients,
which cost about $28 for a 120-day supply (compared with $632
brand name OxyContin),21
taxpayers are still paying at least $56 million for Medicaid
opioid prescriptions.
The cost of the opioid prescriptions does not take into
consideration state-run drug treatment programs and services
that are required if and when enrollees become addicted.
In December 2015, Purdue, the maker of OxyContin, settled an
ongoing lawsuit brought by the state of Kentucky for $24 million
over presenting OxyContin as “nonaddictive.”22
Purdue contended that the pill slowly releases the drug over 12
hours when swallowed, omitting the fact that, when crushed,
OxyContin lost its time release protections and created an
instant high.
“State officials said that led to a wave of addiction and
increased medical costs across the state, particularly in
eastern Kentucky where many injured coal miners were prescribed
the drug,” reported the Associated Press. (Purdue substituted an
abuse-deterrent version in 2010.)23
The 2015 settlement is similar to one Purdue Pharma agreed to
in 2007 with the state of West Virginia, when it agreed to pay
out $634 million for "fraudulent conduct caused a greater amount
of OxyContin to be available for illegal use than otherwise
would have been available."24
Government’s Response to the Epidemic Is Clueless and
Hypocritical
In February, President Obama proposed adding $1.1 billion in
the 2017 budget to expand prescription drug and heroin abuse
treatment and make naloxone, the overdose-reversal drug, more
available.25
The funding includes millions to help individual states treat
opioid abuse as well as to fund 700 health care providers within
the National Health Service Corps.
Additional millions in the President’s proposal will support
opioid abuse-related activities of the Departments of Justice,
Health and Human Services and of law enforcement. The measures
ignore the many ways the government itself has enabled the
opioid epidemic.
The same week in 2013 that the U.S. Food and Drug
Administration (FDA) announced plans to tighten restrictions on
hydrocodone containing products like Vicodin,26
it approved Zohydro made from pure hydrocodone
bitartrate, which has 5 to 10 times the abuse potential of
OxyContin.27
(All other hydrocodone-containing painkillers on the market are
mixed with other non-addictive ingredients.)
It did so over the objections of many medical and public
health groups and its own advisory committee. Soon after, also
over intense objections, the FDA approved OxyContin for children
as young as 11.28
The long-acting opioids that became so highly abused were
ironically introduced for a good reason. The formulations solved
three problems associated with short-acting opioid drugs.
Because short-acting drugs, which are taken as needed,
require 20 to 30 minutes to work and last only two to four
hours, peak pain periods were often missed, leading to excessive
doses and risks. Secondly, most short-acting opioids are
combined with acetaminophen (Tylenol), which causes liver damage
at high doses.
Finally, short-acting opioids taken as needed encouraged
addictive, “reward-seeking” behavior. Long-acting opioids, taken
on a time-contingent basis instead of as needed were believed to
be a safety improvement. And they were — until users discovered
they could crush and snort them and even shoot up them like
heroin.29
Misleading Data Used to Approve More Potent Pain Drug
When the FDA approved Zohydro — even as it was recommending
tighter controls on narcotic painkillers — then FDA Commissioner
Margaret Hamburg claimed that "100 million Americans" suffer
from severe chronic pain, which justified the approval.
But, there are problems with the 100 million figure, which
originated with a report created by the Institute of Medicine
(IOM), titled: "Relieving Pain in America, A Blueprint for
Transforming Prevention, Care, Education, and Research." This
report warns against restricting the use of opioid drugs because
so many people "need" them, but 9 of the 19 panel experts that
produced this statistic were found to have undisclosed financial
ties to companies that make opioids.
'Pain experts disputed the 100 million figure as misleading,
since IOM “defined up” chronic pain to include pain lasting
three to six months, regardless of the cause or severity. The
figure also includes not only those with chronic but manageable
pain, but those recovering from surgery or undergoing cancer
treatment.
A paper published by the National Institutes of Health
Pathways to Prevention Workshop in 2015 places the number of
Americans with "moderate to severe chronic pain that limits
activities and diminishes quality of life" at 25 million, which
is more likely accurate. Addressing the new childhood
indication, the Washington Post wrote:30
“The decision was welcomed by some pediatricians and
pain specialists, but it also provoked fierce criticism. On
social media, people accused the FDA of acting irresponsibly
and putting the interests of OxyContin’s manufacturer,
Purdue Pharma, ahead of the welfare of children, who they
worried would become addicted to the drug.
Sen. Joe Manchin III (D-W.Va.), whose state has been
especially hard hit by the epidemic of prescription drug and
heroin abuse, wrote a scathing letter, telling the FDA it
‘should be absolutely ashamed of itself for this reckless
act.’ He warned that the decision could lead to ‘poisoning
our children’s brains and setting them up for future drug
abuse,”’and called for a Senate investigation into the
decision.”
Opioids Change Your Brain and Promote Addiction
Sen. Joe Manchin is correct. After only one month, subjects
with
chronic low back pain who received morphine in a 2016 study31
by researchers at the University of Alabama at Birmingham had a
3 percent reduction in their brain’s gray matter volume. The
reductions occurred in regions of the brain that regulate
emotions, cravings and pain response.
A 2011 study found similar damage after only one month’s use
of daily morphine. Changes were seen in the amygdala, reported
the researchers; the brain region “involved in drug-induced
associative learning, drug craving, reinforcement, the
development of dependence, and the experience of acute
withdrawal.” Atrophy in the amygdala is “an important area of
morphologic difference distinguishing opioid-dependent
individuals from healthy controls,” wrote the researchers.
Long-term behavior patterns governed by the amygdala can
continue in the absence of pleasure, setting the stage for
opioid misuse they said. High school heroin use starts with
painkillers in 3 out of 4 cases, says other recent research.32
People who end up using heroin “rarely just start with heroin,”
said the study’s author Joseph Palamar, Ph.D., public health
expert at NYU Langone Medical Center, New York:
“They resort to heroin when they can no longer afford
their expensive pill habit or when their source for pills
has become cut off. Since white individuals are at highest
risk for nonmedical use of opioid pills, this now places
them at high risk for future heroin use. Addiction to opioid
pills is now driving a lot of people to heroin use ...
Teens need to be taught how dangerous and addicting
opioid pills can be, and that they aren’t safe just because
they’re pharmaceutical grade, government-approved, and
possibly in their parents’ medicine cabinet.”
Opioids Provide No Long-Term Benefits
In addition to brain changes that affect learning, behavior,
emotions, and foster addiction, there exists no scientific
evidence of the long-term benefits of opioids says a 2015
Medscape article:33
“Recent reports have consistently concluded that
there are insufficient data on the long-term effectiveness
of prescription opioids to support their use in the
treatment of chronic pain, but there is clear evidence of a
dose-dependent risk for serious harms.
The biggest triggers to the initiation and
perpetuation of prescription opioid abuse comes from their
use for the treatment of nonspecific musculoskeletal
disorders, especially chronic low back pain, headaches, and
disorders such as fibromyalgia.
Although there is no proven benefit for their use in
these disorders, ‘people with these indications are on
chronic opioids, and they have become disabled, and they are
spilling over into social security and disability systems,’
Dr. Franklin [vice president of Physicians for Responsible
Opioid Prescribing] said.”
Despite research that confirms the addiction potential of
opioids and their gateway to heroin use and addiction, opioid
salesmen have hidden the risks say lawsuits. According to
Bloomberg,34
the Kentucky lawsuit charges Purdue with training “its sales
force to falsely portray OxyContin as difficult to abuse, even
though its own study found a drug abuser could extract most of
the active ingredient from a tablet by crushing it.”
“Addicts quickly learned how to get high from a
single pill, which contained far more pain-relief medicine
than older drugs because of its long-acting feature,”
Bloomberg continues. “The Kentucky action claims that
sales representatives misled doctors and others into
believing that OxyContin didn’t produce a ‘buzz’ and was
less addictive than shorter-acting drugs.
It alleges the company concealed information about
the dangers of OxyContin. The 12 claims against the company
include Medicaid fraud, false advertising, creating a public
nuisance, and unjust enrichment. Abbott Laboratories, which
at one time co- promoted OxyContin with Purdue, is also
named as a defendant.”
Signs That Opioid Problem Is Getting Worse
Americans use the most opioids of any nation — twice the
amount used by Canadians, who come in second place in terms of
prescriptions. So many Americans are on opioids, there is now a
huge market for drugs to treat opioid induced constipation (OIC)
and a major TV spot for OIC ran during the televising of the
2016 Super Bowl.35
The ad “speaks volumes not about OIC, but the much greater
problem of opioid addiction — both overly prescribed
prescription painkillers and the current problem of illicit
street drugs like heroin,” writes Dr. Akikur Mohammad, an
adjunct professor at University of Southern California Keck
School of Medicine and the author of “The Anatomy of Addiction.”36
“The fact that there are enough painkiller users to
necessitate the likely millions of dollars that ad cost
underscores we have an epidemic. And prescribing doctors
must be more responsible in doling out prescription
painkillers to combat it.”
Of course, constipation is the least of concerning side
effects. Many Americans fail to realize that
opioid prescription painkillers are very similar to heroin
and, like heroin, depress your heart rate and breathing. Large
doses can cause sedation and slowed breathing to the point that
breathing stops altogether, resulting in death.
Stopping the drugs on your own, meanwhile, is difficult and
causes significant withdrawal symptoms, including flu-like
symptoms (nausea, vomiting, diarrhea, weakness and muscle
cramps) that may last for up to 10 days.
Opioid Antidote Now Carried by National Pharmacy Chains
Luckily, awareness of the epidemic is increasing and there
are hopeful signs. Walgreens recently announced that it is
implementing "opioid disposal kiosks" in more than 500 stores in
39 states and Washington D.C. which allow customers to quickly
and easily dispose of opioids and other controlled substances —
no questions asked.37
The top drugstore chain also announced it is making naloxone,
the lifesaving opioid antidote, available without a prescription
at 5,800 of its pharmacies in 35 states, starting with New York,
Indiana and Ohio. As an injectable drug or nasal spray, naloxone
can reverse the
effects of heroin and opioid doses and is increasingly
carried by law enforcement and paramedics.
The life-saving idea seems to be catching on. Kroger Co., the
Ohio-based grocery chain, will also make naloxone available
without a prescription in its pharmacies across Ohio and
northern Kentucky.38
"We want families dealing with addiction to know that they can
count on having the drug available in the event that they need
it," said Kroger vice president of merchandising Jeff Talbot.
"This marks an important step in our fight to combat
addiction," agreed U.S. Sen. Rob Portman (R-OH). CVS Health Corp
is also on board with the prescription-free naloxone plan for
all its Ohio pharmacies.39
While this will help save lives, the idea that drug stores and
schools are now starting to keep opioid antidote on hand just
because so many people use them is a sad testament to the
enormity of the problem.
If you suffer with any kind of pain, I urge you to try other
alternatives first. There are instances where an opioid may be
warranted for a short period of time, such as post-surgery, but
most people who use them are in chronic pain, and opioids cannot
be used safely in the long term. For a list of suggestions to
try before you opt for a prescription painkiller, please see my
previous article, “Prescription
Painkillers Lack Evidence of Safety and Effectiveness for
Long-Term Use.”
© Copyright 1997-2016 Dr. Joseph Mercola. All Rights Reserved.
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