FDA Fueled Opioid Epidemic
By William Faloon
Heroin is one of the most addictive substances on earth.
When deprived of opioid drugs like heroin or oxycodone, addicts endure harsh withdrawal that often requires medical intervention. The addict may then undergo long-term treatment to reduce odds of relapsing.1
Recovering opioid addicts may not sleep properly for years. Relentless physical and mental cravings result in over 90% of treated users resuming opioid addiction.2 The final exit for many is recovery or death.
Opioid addiction has skyrocketed in the United States as have fatal overdoses.3
To meet the surging demand, synthetic opioids (like fentanyl) are smuggled into the United States. Those convicted of trafficking opioids can face decades of incarceration.4,5
What if, instead of risking prison, you duped the FDA into approving a synthetic opioid drug for routine pain relief?
That way doctors would widely prescribe your opioid drug with insurance companies paying for it.
Having physicians inadvertently hook their patients creates a large base of addicts who will do anything to avoid the horrors of opioid withdrawal.
That’s what a pharmaceutical company accomplished when it got the FDA to approve their time-released oxycodone in 1995.6
With FDA’s approval in hand, the company launched a marketing campaign to mislead doctors and patients about the risk for addiction and abuse of their opioid drug.6
This article will open your eyes to facts that should have precluded OxyContin® from ever being approved for widespread use.
For those with persistent discomforts, help is available. Greater use of natural alternatives may reduce the growing population of Americans who become dependent on opioid drugs that are approved by the FDA.
An estimated 100 million Americans suffer chronic pain.7
Pain prevalence increases with age due partly to chronic inflammatory issues that exacerbate degenerative diseases such as arthritis and traumatic injury.
Opioid drugs provide immediate relief, but fail to correct the underlying inflammatory problem.
As pain sufferers become tolerant to narcotic drugs, they need to increase their dose. Increased dosage is required to keep their pain in abeyance and to satisfy their unintended addiction to the synthetic opioid their doctor prescribed.
Patients who thought they were going to take “pain pills” for a limited period find themselves hooked on a narcotic drug, something they might refuse if they knew of its addiction risk.
The complex factors that create opioid addiction are incompletely understood.8 The public gets confused when terms like “detoxification” are used to describe what an addict endures to get off opioid drugs.
As you’ll read next, opioid addiction is more difficult to cure than merely removing a “toxin.”
How the Brain Gets Addicted
May Not Sleep Properly
Brain cells contain opioid receptors.8
When a person takes an opioid drug, it quickly fills opioid receptor sites to relieve pain while inducing calmness and euphoria in many people.
Continued opioid drug use (be it heroin or oxycodone) causes opioid receptors to become desensitized in a way that often necessitates higher doses of the opioid drug to keep the brain from going into a physical withdrawal.
In the state of acute withdrawal, the opioid receptor sites in the brain scream for more opioids. With insufficient opioids, the addict can experience intense pain throughout their body that is already agitated because their desensitized opioid receptors are unable to transmit neuronal signals the addict needs to feel normal.
Acute withdrawal is a physical phenomenon that can require medical intervention to prevent possible death. During the acute and chronic withdrawal period, the opioid addict may be unable to achieve normal sleep and is likely to suffer from relentless discomfort and intense agitation, along with craving for opioid drugs.
Over a multi-year recovery period, the opioid receptor sites can become re-sensitized to the low levels of natural opioids produced in the body. This in turn slowly enables the opioid addict to regain a sense of normalcy.
Sleep deprivation, however, can last for years as the brain is unable to achieve sufficient relief from the anxiety because their opioid receptor sites were so damaged. Instant relief can be found by reaching for a heroin or oxycodone “fix,” which can ignite another vicious addiction cycle.
The body produces natural opioids that help mitigate pain and reduce anxiety. There are not enough natural opioids produced, however, to compensate for the loss of receptor site sensitivity caused by prior abuse of the opioid drug.
Understanding how opioids create physical addiction makes the FDA’s approval of opioid drugs (like OxyContin ®) all the more abhorrent.
How Heroin Abuse was Temporarily Curbed
In the 1960’s, compelling film footage of heroin addicts twisting and screaming as they were strapped to hospital gurneys was shown to high school students. This film footage vividly revealed the horrors that heroin addicts endure as they fight through the acute withdrawal phase.
These films often depicted addicts cooking heroin in rusty spoons and using dirty needles to inject it into their quivering bodies. The visual impact was significant.
Much of society back then viewed heroin (opioid) junkies with disdain. Educated individuals said no to needles and opioids.
The reason for the resurgence of addiction and overdose deaths is the FDA approved an opioid drug that was illegally marketed to physicians as a relatively “safe” pain reliever.
Where Today’s Opioid Epidemic Started
In the early 1990s, a company called Purdue Pharma developed a highly-addictive semi-synthetic opioid drug and named it OxyContin®.9 The company funded clinical trials showing that OxyContin® in long-acting form relieved pain for up to 12 hours with few of the side effects associated with opioid drugs.10
The Food and Drug Administration (FDA) reviewed the company-funded clinical studies on the use of OxyContin® and approved it. The FDA was told that because OxyContin® was in a “time-release” tablet, it posed a lower threat of abuse and addiction.10
The FDA reviewer (Curtis Wright, MD) who led the approval of OxyContin® left the FDA and within 2 years was working for Purdue Pharma.10
This kind of revolving door between the FDA and pharmaceutical companies has been previously exposed in this magazine, and more recently in the Washington Post and on the CBS TV program 60 Minutes.
We view this revolving door as deferred bribery or “business as usual” as it relates to how the FDA approves new drugs and allows dangerous ones to remain on the market.
Purdue Pharma heavily promoted their OxyContin® to primary-care physicians who had little training in the treatment of serious pain or in recognizing signs of drug abuse.6 OxyContin® rapidly became the instant fix for patients complaining of any kind of discomfort since the drug usually provided immediate relief.
OxyContin® does this by occupying the opioid receptor on brain cells. As pain returned, so did the patient for a refill of higher-dose OxyContin® to counteract the desensitized (less responsive) brain cell opioid receptors caused by their prior use of OxyContin®.
It did not take long for experienced drug abusers and novices to discover that chewing an OxyContin® tablet, crushing it and snorting the powder, or injecting it with a needle produced a high as powerful as heroin.
By year 2000, parts of the United States began to see skyrocketing rates of addiction and crime related to OxyContin®,11,12 which has severely worsened in recent years.
Purdue Pharma Gets Indicted13
Between 1995 and 2001, Purdue Pharma brought in revenue of $2.8 billion from sales of its FDA-approved OxyContin® drug.13
The active ingredient in OxyContin® is oxycodone, which is a semi-synthetic opioid narcotic.
Unlike drugs such as Percocet® that contain oxycodone and other ingredients, OxyContin® contained large amounts of pure oxycodone in each time-released tablet.
Purdue Pharma recognized they would face resistance from doctors who were concerned about the potential for OxyContin® to cause addiction.13
To counter this, the company developed a fraudulent marketing campaign designed to promote OxyContin® as a time-released drug that was less prone to such problems.13
As addiction rates soared, Purdue Pharma and its executives were criminally charged for misrepresenting the addiction potential of OxyContin® to physicians.
In 2007, Purdue Pharma settled the criminal charges by paying a $634 million fine.6 The executives who perpetrated the crimes were not sentenced to serve any jail time and the company was allowed to continue selling different versions of oxycodone-containing drugs.14,15
As had been widely reported in recent years, neither Purdue Pharma nor the FDA has effectively stopped what has been an explosive growth in America’s addiction for opioid drugs that Purdue conned the FDA into approving 23 years ago.
While heroin dealers forfeit their property and personal liberty, those responsible for today’s opioid addictionepidemic continue to profit enormously. This is courtesy of the FDA approving and allowing ongoing sale of opioid prescription drugs.
FDA fuels this epidemic further by approving lower-cost generic opioid narcotics.
Yet the public does not understand how easy it is for brain cells to develop a physical craving for opioid drugs (and not everyone prescribed opioids becomes dependent or addicted).
Opioid Epidemic Reaches All-Time High in 2017
The FDA initially allowed Purdue Pharma to market a theory that OxyContin® was less prone to addiction than typical opioids.
This bureaucratic blunder in 1995 is the genesis of today’s nationwide crisis of opioid addiction, overdoses, and deaths. This includes heroin (from poppies), oxycodone, and more powerful opioid-receptor site occupiers such as fentanyl(which is an opioid drug sometimes used for general anesthesia).16-19
The charts on these pages speak for themselves.20,21
These bleak numbers reflect over 200,000 lost lives caused by opioid drugs that never should have been approved for widespread use.
The Centers for Disease Control and Prevention (CDC) revealed research in 2017 suggesting that the numbers of deaths attributed to opioid abuse are grossly underestimated.22-24
I cannot tell you how many times I’ve said NO to doctors and dentists who have offered me OxyContin®prescriptions with lots of refills.
I angrily bark back at these doctors by asking, “Are you out of your mind?” for trying to prescribe me a narcotic for something that is not particularly painful.
But how would a typical patient know to refuse an opioid prescription?
After all, the drug is approved by the FDA to treat pain. And since much of the public still thinks the FDA protects the public health, people generally follow their doctors prescribing orders.
The reality is the FDA should have known if you give a person an opioid drug, some will become addicted in a way that their brain cells constantly crave more of the opioid compound.8
Opioid addiction has reached crisis levels despite record numbers of people being incarcerated for its illicit distribution.
Education Over Incarceration
I continue to advocate education over incarceration as the nearly 40-year “war on drugs” has been an abysmal failure. This is evidenced by massive numbers of:
• Opioid addicts25-27
• Opioid overdose fatalities28-30
• Drug addiction treatment centers31
• Incarcerated drug traffickers (who are often addicts themselves)32,33
Educating school children about the mechanisms of opioid tolerance, dependence, addiction, and withdrawal will go a long way to dissuade them from considering an opioidcompound.
Opioids need to regain the stigma that was successfully imparted on my generation in the 1960s/1970s era.
HORRORS OF OPIOID WITHDRAWAL
When an addict acutely stops taking their opioid drug, they can endure multiple physical withdrawalsymptoms including:8,34
• Systemic pain as the opioid receptors in their brain are no longer occupied by the opioid drug.
• Flu symptoms like runny nose, watery eyes, diarrhea, and nausea.
• Hot and cold sweats that involve feeling cold and shivering uncontrollably while simultaneously profusely sweating.
• Persistent insomnia that can last for years before normal sleep is restored.
These physical-withdrawal agonies can be vanquished by resuming the opioid drug.
In addition to the acute withdrawal agonies, there is a constant craving to have those brain opioid receptors occupied by an opioid drug, without which the addict cannot feel normal.
Is it any wonder that up to 90% of addicts who undergo medical intervention resume their opioid drug use?2
The horrific consequences of opioid withdrawal, including the skyrocketing numbers of lethal overdoses, makes the FDA’s approval of OxyContin® even more heinous.
Dealing With Reality
It is estimated that one-third of Americans suffer chronic pain.7
Drugs like OxyContin® effectively treat serious short- and long-lasting pain.
The problem is that some people become addicted with their very first opioid prescription. This can occur as opioid receptors become less responsive to the drug, triggering a vicious cycle where more drug is needed to achieve desired effect.
Last month we introduced an alternative solution for those who suffer chronic pain. This dual-nutrient formula is capable of modulating pain signals and modifying inflammatory responses that lead to systemic pain sensation. There is no escape, however, from the agonies of acute and long lasting opioid withdrawl.
In this month’s issue, we publish a brief review of the carnage of opioid addiction and overdose deaths that are sweeping the United States.
This would not have happened had the FDA bothered to look at the underlying mechanism of opioid addiction before approving a controlled-release opioid for widespread use in 1995.
We also introduce this month a new prebiotic chewable tablet that feeds the beneficial bacteria in your gastrointestinal tract. This special prebiotic is designed to help boost healthy bifidobacteria levels that critically decline with age.
AS THIS ARTICLE WAS BEING FINALIZED…
Most of this article was written in April 2017.
Before it could appear in Life Extension Magazine®, the media woke up to the opioid crisis that is causing horrific human suffering and record-setting overdose deaths.
In October 2017, CBS News’s 60 Minutes in conjunction with the Washington Postaired an investigative report exposing federal government corruption that continues to fuel “the worst drug epidemic in American history.”35,36
The FDA is responsible for initiating this addiction crisis and intensifying it by approving more opioid drugs for sale at your local pharmacy. The FDA is now trying to remove some of the generic opioid drugs that are most likely to create addiction.
As body counts rose from overdose deaths, however, the Drug Enforcement Agency (DEA) tried to stop the illicit distribution of FDA-approved opioid drugs. Big Pharma responded by hiring away DEA’s top attorneys and enforcement staff.
Big Pharma went further and lobbied Congress for new legislation that impedes the ability of the DEA to curb illicit distribution of FDA-approved opioids.
The bill, written and sponsored by Big Pharma, passed Congress by unanimous consent in 2016 and was signed into law by the president.
To view this CBS News/Washington Post joint expose on federal corruption, visit: www.LifeExtension.com/opioid
We at Life Extension have exposed FDA incompetence and corruption relating to fraudulent drug approvals dating back to the 1980s.
The new scandal revealing how our federal government initiated and fuels the opioid crisis is a sad but accurate vindication of our long-standing revolving-door allegations, whereby federal employees view their work as paving the way to lucrative careers in the industry they supposedly “regulate” under the deceitful guise of consumer protection.
Recall that the FDA reviewer who led the approval of OxyContin® left the FDA and within two years was working for Purdue Pharma (maker of OxyContin®).
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- Available at: https://www.addictioncenter.com/community/in-remembrance-of-philip-seymour-hoffman-the-importance-of-education-in-recovery/. Accessed October 16, 2017.
- Smyth BP, Barry J, Keenan E, et al. Lapse and relapse following inpatient treatment of opiate dependence. Ir Med J. 2010;103(6):176-9.
- Available at: https://www.usnews.com/news/blogs/data-mine/2015/07/07/heroin-use-skyrockets-in-us-cdc-says. Accessed October 16, 2017.
- Available at: https://www.ussc.gov/sites/default/files/pdf/research-and-publications/quick-facts/Heroin_FY15.pdf. Accessed October 16, 2017.
- Available at: https://fas.org/sgp/crs/misc/RL30722.pdf. Accessed October 16, 2017.
- Van Zee A. The promotion and marketing of oxycontin: commercial triumph, public health tragedy. Am J Public Health. 2009;99(2):221-7.
- Reuben DB, Alvanzo AH, Ashikaga T, et al. National institutes of health pathways to prevention workshop: The role of opioids in the treatment of chronic pain. Annals of Internal Medicine. 2015;162(4):295-300.
- Kosten TR, George TP. The neurobiology of opioid dependence: implications for treatment. Sci Pract Perspect. 2002;1(1):13-20.
- Jayawant SS, Balkrishnan R. The controversy surrounding OxyContin abuse: issues and solutions. Ther Clin Risk Manag. 2005;1(2):77-82.
- Available at: http://www.latimes.com/projects/oxycontin-part1/. Accessed October 18, 2017.
- Available at: https://www.nytimes.com/2001/07/29/magazine/the-alchemy-of-oxycontin.html. Accessed October 26, 2017.
- Available at: http://fortune.com/2011/11/09/oxycontin-purdue-pharmas-painful-medicine/. Accessed October 26, 2017.
- Available at: https://www.nytimes.com/2007/05/10/business/11drug-web.html. Accessed October 18, 2017.
- Available at: https://www.nytimes.com/2007/07/21/business/21pharma.html. Accessed October 11, 2017.
- Available at: http://www.purduepharma.com/healthcare-professionals/products/. Accessed October 26, 2017.
- Available at: https://www.nytimes.com/interactive/2017/09/02/upshot/fentanyl-drug-overdose-deaths.html. Accessed October 18, 2017.
- Available at: http://www.cnn.com/2017/09/08/health/heroin-deaths-samhsa-report/index.html. Accessed October 18, 2017.
- Available at: http://www.businessinsider.com/opioid-overdose-death-statistics-2017-2016. Accessed October 18, 2017.
- Available at: https://www.statnews.com/2017/06/27/opioid-deaths-forecast/. Accessed October 18, 2017.
- Available at: https://www.vox.com/policy-and-politics/2017/6/6/15743986/opioid-epidemic-overdose-deaths-2016. Accessed October 27, 2017.
- Available at: https://www.nytimes.com/interactive/2017/08/03/upshot/opioid-drug-overdose-epidemic.html. Accessed October 27, 2017.
- Available at: https://www.cdc.gov/media/releases/2017/t0425-EIS-conference.html. Accessed October 18, 2017.
- Available at: http://www.cnn.com/2017/04/24/health/opioid-deaths-cdc-report/index.html. Accessed October 26, 2017.
- Available at: https://www.cdc.gov/media/dpk/cdc-24-7/eis-conference/pdf/Infectious-disease-complicates-opioid-overdose-deaths.pdf. Accessed October 26, 2017.
- Available at: http://www.cnn.com/2017/06/29/health/opioid-addiction-rates-increase-500/index.html. Accessed October 18, 2017.
- Available at: http://www.theguardian.com/us-news/series/americas-addiction-epidemic. Accessed October 18, 2017.
- Available at: https://www.asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf. Accessed October 18, 2017.
- Available at: https://www.nytimes.com/interactive/2017/06/05/upshot/opioid-epidemic-drug-overdose-deaths-are-rising-faster-than-ever.html. Accessed October 18, 2017.
- Available at: https://sputniknews.com/us/201703071051325942-drug-overdose-rates-us/. Accessed October 18, 2017.
- Available at: https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed October 18, 2017.
- Available at: https://www.samhsa.gov/data/substance-abuse-facilities-data-nssats/reports?tab=10. Accessed October 18, 2017.
- Available at: http://www.drugwarfacts.org/chapter/drug_prison. Accessed October 18, 2017.
- Available at: https://www.bjs.gov/content/pub/pdf/dofp12.pdf. Accessed October 18, 2017.
- Available at: https://www.addictionsandrecovery.org/opioid-opiate-recovery.htm. Accessed October 18, 2017.
- Available at: https://www.washingtonpost.com/graphics/2017/investigations/dea-drug-industry-congress/. Accessed October 27, 2017.
- Available at: https://www.cbsnews.com/news/ex-dea-agent-opioid-crisis-fueled-by-drug-industry-and-congress/. Accessed October 27, 2017.