© Enny Nuraheni / Reuters
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."