By Dr. Mercola
Heroin belongs to a class of drugs called opioids. All drugs in this class are chemically related, including street drugs and those prescribed by physicians. They affect chemical receptors in your nervous system to produce pleasurable sensations and reduce pain.1
Legal prescriptions include oxycodone, hydrocodone, codeine, morphine, fentanyl and many others.2 According to the American Society of Addiction Medicine (ASAM), of the 21.5 million Americans with a substance abuse disorder in 2014, 1.9 million were addicted to prescription pain relievers and 585,000 were addicted to heroin.3
America's addiction to pain medication begins in the physician's office. Drug companies have shrewdly misled doctors and patients, purposely downplaying the abuse potential of these drugs.4 As a result of this, drug overdoses are now the leading cause of accidental death, with opioid addiction driving the epidemic.5
In 1971 the U.S. Food and Drug Administration (FDA) approved the use of naloxone to reverse heroin drug overdoses.6 Today it is carried by first responders and used in hospitals and clinics. However, where the drug was once very affordable, prices have skyrocketed right along with the prevalence of opioid addiction.
Profits Over People
Originally, naloxone was designed for injection only. With the rapid rise of opioid overdoses and use of the medication in the field, drug companies looked for another method of administration.
In 2012, The National Institute on Drug Abuse and Opiant Pharmaceuticals joined together to develop an intranasal administration device, which was approved by the FDA in 2015.7
As recently as the early 2000s, the cost of naloxone hovered around $1 per dose. Today the drug costs close to $40 per dose and the price keeps rising.8 Apparently, Big Pharma is taking full advantage of the race to get the medication in the hands of all first responders and even into most households.
In an effort to justify a new price on an old drug, companies are blaming rising costs of manufacturing the medication, new packaging and new methods of administration.9 However, generic versions of the drug continue to cost pennies in other countries while the price growth in the U.S. is on a steep curve.
U.S. Senator Bernie Sanders (D-Vermont), with U.S. Representative Elijah Cummings (R-Maryland), opened an inquiry in 2015 into Amphastar Pharmaceuticals, the most commonly used version of naloxone by emergency personnel and in private homes. Sanders was quoted in Politico, saying:10
"Opioid abuse is an epidemic across our country, yet drug companies continue to rip off the American people by charging the highest prices in the world because they have no shame. The greed of the pharmaceutical industry is killing Americans."
Drug companies have had their hand in both creating the problem through falsely promising physicians their version of opioids were non-addictive, and now raising the price of the overdose reversal drug so high it may be considered extortion, essentially placing greed and profits above the needs of people.
Growth of the Opioid Epidemic and Rising Cost of Reversal Medication Is Influencing Political Platforms
Expressing her distaste at the drug industry's apparent lack of concern for people's lives, Eliza Wheeler, who leads a drug overdose prevention and education project in Northern California, noted:11
"You have increased demand and a few people who control the pricing, so they can charge whatever they want."
States in the U.S. experience varying degrees of opioid addiction problems. Physicians in Alabama prescribe three times the number of narcotic painkillers than physicians in Hawaii.13 Both presidential candidates have jumped on the opioid epidemic as part of their political platforms.
Donald Trump has demonstrated his lack of understanding of how people are becoming addicted, advocating building a wall between the U.S. and Mexico to eliminate the traffic of heroin into the U.S. without addressing increasing prescriptions of narcotics.14
Despite the fact that the drug is no longer under patent, a virtual monopoly of four or five companies controls the rise in price. They justify the price hikes saying it's related to the cost of the delivery system and not the drug itself.
These companies are donating thousands of dollars to super delegates who are pledging their votes to Hillary Clinton in the November election.15,16,17, 18
Clinton, in turn, has laid out a five-point plan based on prevention, treatment and emergency care that on the surface sounds reasoned and actionable, including training physicians to recognize substance abuse and reduce prescription rates of controlled substances.19
Part of that plan is to put naloxone in the hands of every first responder to reduce the number of lethal overdoses. The number of opioid prescriptions dispensed by U.S. pharmacies in 1991 reached 76 million.20
This number almost tripled by 2011, reaching 211 million prescriptions. While treatment for overdoses is essential for first responders, addressing the growing number of narcotic prescriptions is necessary to address the rising epidemic of opioid addictions.
Overdose Victims — A 'Boon' to the Organ Donation Industry?
Depending upon the drug an addict has taken, first responders may need more than one dose of naloxone to reverse the effect and save the individual. Almost 30,000 deaths were attributed to prescription or street opioids in 2014.21
Contingent on what street dealers cut their drugs with, one or even two doses of naloxone may not be enough to save a life.22
As a result of a growing epidemic of addiction and overdoses and rising costs of rescue medication, more drug addicts are experiencing lethal consequences from the drugs they're taking.
In years past, drug addicts were not considered viable transplant donors as they may have been infected with HIV or hepatitis C.23 In 2013, federal law changed to allow HIV positive organs to be transplanted to an HIV positive patient.24
In a sad and twisted turn of events, between January and October 2016, 69 people in the New England states who died from an overdose donated their organs, saving the lives of 202 other people.
Alexandra K. Glazier, chief executive of the New England Organ Bank, was quoted in The New York Times, saying:25 "It's an unexpected silver lining to what is otherwise a pretty horrendous situation."
According to the New England Organ Bank, responsible for donations and distribution to transplant patients in the New England states, donations from overdose deaths accounted for 27 percent of donations, up from 4 percent in 2010.26
This steep increase in drug overdose organ donations highlights both the incredible need for greater efforts in prevention and treatment of drug addiction and the growing need for more individuals to become organ donors.
The need for donors continues to grow; 85 people receive an organ donation each day and another 22 die before a suitable match can be found.27 Although drug overdose victims were considered high risk donors in the past, improved screening protocols have significantly reduced the risk of transplanting an infected organ.
Number of Companies Supplying Reversal Agents Climbing but Prices Are Not Stabilizing
The rising price of naloxone is straining the budgets of first responders as explained in this video. According to the CDC, enough prescription pain medication was dispensed in 2010 so every adult in America could be medicated around the clock for one month.28 Those numbers have increased, as have the number of doses of naloxone dispensed from pharmacies.
As the price of naloxone rises, so do the reported sales and profits of the companies providing the drug. Amphastar, the primary provider of injectable naloxone to emergency personnel, reported net revenue in the last quarter of 2015 of $77 million.29 This was a 38 percent increase from the 2014 fourth quarter. According to an Amphastar press release:30
"Other finished pharmaceutical product revenues were $36.6 million for the quarter, an increase of 69 percent compared to $21.7 million for the third quarter of 2014, which was primarily due to an increase in sales of naloxone to $10.5 million from $3.7 million, as a result of increased unit volumes at higher average prices."
This life-saving medication is bolstering the profits of more than one company. Adapt, Hospira and Amphastar pharmaceutical companies had been the main providers of naloxone.31 Kaleo Pharmaceuticals introduced an auto-injector costing $700 to $800 per dose. Biotech company Mylan now sells an injectable form after approval in 2014, and INSYS Therapeutics, suffering from a media backlash concerning their sales of Fentanyl, has now been fast-tracked by the FDA for a naloxone product.
When talking about the recent FDA approved nasal-spray of naloxone, Michael Botticelli, director of the White House Office of National Drug Control Policy (ODNCP), said this was done to improve the competition between pharmaceutical companies.32 Although the hope may have been to reduce prices when four to five companies are producing the medication, it hasn't happened.
Big Pharma wants insurance companies to pay their bloated fees. In an interview with Fusion, Kaleo spokesperson Mark Herzog mentioned that "3 out of 4 Americans" have insurance that covers their naloxone product and the median out of pocket expense was $20.33
Naloxone Is a Bandage and Not the Cure
The epidemic of people addicted to opioid painkillers, heroin and cocaine will not be stopped by using rescue drugs to prevent deaths. However, Big Pharma is also not interested in shrinking the supply of narcotic addictive pain medication or, it seems, in reducing the price of medication needed by emergency personnel to save lives.
Pharmaceutical companies understand that it's impossible to place a price on saving a life, and they are taking full financial advantage at the cost of their customers. Budgets for first responders are not limitless, so in order to pay for the naloxone, other line items must be cut. At some point this may affect the emergency care you receive in your community.
Stemming the tide of an epidemic starts by reducing potential at the source. When the World Health Organization (WHO) set up their epidemic response guidelines for disease, they consulted Dr. David Heymann of the London School of Hygiene and Tropical Medicine.34 He wisely recommends shutting down a steady supply of victims, treating those already infected and monitoring the situation for changes.
The same holds true for the opioid epidemic. Before a significant change is evident in the effect on public health, the number of new addicts must be slowed. Surveillance programs to identify addicts, treatment programs for those already addicted and rescue medication for those who overdose, are steps taken to address a current problem, not a growing one.
As 1.9 million people are addicted to prescription opioids, more than three times the number addicted to street opioids,35 slowing the number of new addicts begins with reducing the number of narcotic medications prescribed for medical conditions that do not warrant such drastic measures. Pain control is a sensitive and complex topic for those who experience chronic pain, but using highly addictive medications only started to be the answer in the late 1990s.
The bottom line is that repeated use of naloxone just makes good business sense to pharmaceutical companies, and the price hikes may not stop until the provision of rescue drugs is taken out of the hands of the very companies who supply the drugs that create the problem.