Each year, the Drug Enforcement Agency (DEA) sets regulations on the amounts of controlled drugs that are allowed to be manufactured. Over the past three years, the DEA allowed 25% more opioid production than usual. The year 2014 set the record for deaths from drug overdoses, and over 60% of them involved opioids. Citing a decline in demand, the DEA earlier this month has ordered opioid manufacturers to cut production by 25% or more, starting next year.
When setting regulations on the amount of a drug to be produced, the DEA must take into account medical usage, scientific usage, export needs, industrial requirements, and also a reserve stock. The majority of the cuts will be made to this reserve stock, and the cuts will affect almost all Schedule II opioids. (All drugs are divided into Schedules, according to the Food and Drug Administration. Schedule II opioids include oxycodone, fentanyl, hydrocodone, and morphine, among others. For a complete list of Schedules, click here).
The DEA has reported that the demand for opioids has decreased. This is based on sales data represented by the number of prescriptions written by those registered with the agency. However, the current opioid epidemic in America was not overlooked. In its press release, the DEA stated “The 2015 National Survey on Drug Use and Health (NSDUH) released last month found 6.5 million Americans over the age of 12 used controlled prescription medicines non-medically during the past month, second only to marijuana and more than past-month users of cocaine, heroin, and hallucinogens combined.”
Details on the Opioid Production Cuts
In 1970, Congress passed the Controlled Substances Act (CSA), which established a federal drug policy. The CSA created regulations for the manufacture, importation, distribution, possession and use of almost all substances. The CSA also created the Schedule system and the Aggregate Production Quota (APQ), which is what’s being cut next year. The DEA establishes an APQ for over 250 different Schedule I and II substances each year, according to the press report.
For next year, the reserve stocks of most Schedule II opioids will be cut, meaning a 25% reduction, but in the case of hydrocodone and a few other unnamed opioids, the cuts will be 33%. According to the press report, “The purpose of quotas are to provide for the adequate and uninterrupted supply for legitimate medical need of the types of schedule I and II controlled substances that have a potential for abuse, while limiting the amounts available to prevent diversion.” This ‘diversion’ of substances with a ‘potential for abuse’ currently has America in an opioid epidemic.
Just because of Demand Reduction?
Hopefully these production cuts can make a difference. Although a reduction in demand was cited as the main reason for production cuts, the DEA knows we are in an epidemic. In a June press release, Administrator Chuck Rosenberg said, “We tend to overuse words such as ‘unprecedented’ and ‘horrific,’ but the death and destruction connected to heroin and opioids is indeed unprecedented and horrific. The problem is enormous and growing, and all of our citizens need to wake up to these facts.” According to the DEA’s own 2016 National Heroin Threat Assessment Summary, the number of heroin users has recently tripled, and so has the number of heroin deaths.
The following graph, published in 2014 by the National Institute on Drug Abuse, brings up two important points. One is that yes, there is a reduction in the number of prescriptions written from 2012 to 2013, but two is that there is an absurd number of prescriptions being written regardless.
Perhaps this is why in July of this year, six US Senators co-wrote a letter to the DEA calling for stricter limits to be placed on opioid pills. In the text of the letter were some alleged facts regarding the APQs for opioids over the last 22 years. “Between 1993 and 2015, DEA allowed aggregate production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.” While it would be bold to say the DEA is at fault, it is hard to look past the fact that 14 billion opioid pills dispensed per year in this country.
Also hard to look past are the facts that the pharmaceutical companies are pushing for the prescription of opioids, and that medical institutions have been over-prescribing opioids for years now.
Big Pharma wants Big Opioid Numbers
According to the Associated Press and the Center for Public Integrity, opioid medicine manufacturers employ lobbyists and spend millions to “help kill or weaken measures aimed at stemming the tide of prescription opioids.” As a matter of fact, over the past decade, nearly $900 million has been spent advocating and lobbying for pharmaceutical companies, versus the $4 million spent on opioid limiting. Also over the last decade, the opioid industry has contributed to 7,100 state-level political candidates, has averaged 1,350 lobbyists in all fifty states, and has used the Pain Care Forum to influence opioid regulations on the federal level.
Dr. Andrew Kolodny, the founder of Physicians for Responsible Opioid Prescribing, says, “The opioid lobby has been doing everything it can to preserve the status quo of aggressive prescribing. They are reaping enormous profits from aggressive prescribing.” Evidence suggests he’s right. Actually, in 2007, Purdue Pharma, creators of Oxycontin, pled guilty to charges of misbranding and of misleading regulators, doctors, and patients. The dangerously addictive quality of the drug was criminally misrepresented, and Purdue Pharma paid $34.5 million in fines.
The lead lobbyist for Purdue Pharma is also part of the Pain Care Forum.
Doctors Prescribe too many Opioids
According to a national survey, 99% of doctors prescribe opioid medicines for longer than the recommended three-day period. 23% of doctors prescribe a month’s worth of them. Also, 74% of doctors consider morphine and/or oxycodone (both opioids) to be the most effective pain treatment medicines, but National Safety Council (NSC) research suggests the most effective pain treatment meds to be over-the-counter.
Something else 99% of doctors have done is seen a patient who was seeking pills for recreation or seen evidence of drug abuse in a patient, but only 38% of doctors refer such patients to get help. A mere 5% treat the abuse themselves. As published by the NSC, other findings among doctors include:
- 71% of doctors prescribe opioids for chronic back pain, and 55% prescribe them for dental pain – neither of which is appropriate in most cases.
- 67% of doctors are, in part, basing their prescribing decisions on patient expectations; however, a National Safety Council poll in 2015 showed 50% of patients were more likely to visit their doctor again if he or she offered alternatives to opioids.
- 84% of doctors screen for prior opioid abuse, but only 32% screen for a family history of addiction – also a strong indicator of potential abuse.
It’s rather doubtful that any conspiracies are occurring, and it’s highly doubtful that the DEA and big pharma do not care about the skyrocketing number of opioid-related deaths. Regardless, though, we are amidst an opioid epidemic, and much more has to be done before we are in the clear.
An estimated 36 million people worldwide abuse opioids, with over 2 million of them here in the US. Up to half a million Americans abuse heroin. The correlation between non-heroin opioid abuse and heroin abuse is astounding.
The Substance Abuse and Mental Health Services Administration published in 2013 findings that show the “heroin incidence rate was 19 times higher among those who reported prior nonmedical pain reliever (NMPR) use than among those who did not.” (For the record, NMPR abuse is a fancier way of saying opioid pill abuse). Furthermore, 80% of heroin users had previously abused other opioids, whereas only 1% of opioid pill abusers had previously done heroin. It seems Schedule II opioids are a gateway drug to heroin.
Also, as seen in the following graph, the heroin incidence rate itself has been steadily rising for over ten years:
Drug overdose is the number one cause of accidental fatality in America, and opioid-related deaths are fueling this disaster. The sale of prescription pills quadrupled from 1999 to 2010, and hit record numbers in 2014. Prescription pill overdose and death also quadrupled over this time, and also hit a record number in 2014. Surely this is no coincidence.
What is being done?
Aside from cutting production of opioids by up to 33% next year, the DEA also instituted its 360 Strategy last year to help combat the opioid epidemic. The strategy is comprised of three initiatives, together designed to “not only fight drug traffickers but also to make communities resilient to their return.” The three initiatives are:
- To coordinate enforcement actions that target drug traffickers and suppliers
- To advocate responsible prescribing methods by an increase in awareness of the heroin and prescription drug epidemic among manufacturers, wholesalers, medical institutions and pharmaceutical companies
- To empower communities with whatever necessary to combat the epidemic
Head of Philadelphia’s DEA division Gary Tuggle says, “DEA’s 360 Strategy recognizes that we need to utilize every community resource possible to reach young people and attack the heroin and prescription drug epidemic at multiple levels.”
Earlier this year, the Centers for Disease Control (CDC) issued its 2016 Guideline for Prescribing Opioids for Chronic Pain. Adherence to this guideline ensures “safer and more effective chronic pain treatment.” According to the text of the guideline, 20% of patients with non-cancer pain symptoms receive an opioid prescription. In 2012 alone, nearly 260 million opioid prescriptions were written in the US, which was the approximate number of adults living in the US at the time.
Making the new CDC guideline most necessary is the fact that “rates of opioid prescribing vary greatly across states in ways that cannot be explained by the underlying health status of the population, highlighting the lack of consensus among clinicians on how to use opioid pain medication.”
So essentially, the big pharmaceutical companies push for more opioids to be purchased by medical professionals, who in turn over-prescribe opioids, which then leads to opioid dependence in patients. This vicious cycle needs to be cut off somewhere, and hopefully the production cuts for 2017 are a good start.
At a hearing in June of this year, Senator Richard Durbin (one of the six to write a letter to the DEA) pointed out that in 2014, (the year with the most drug overdoses ever), the DEA allowed enough opioid production “for every adult in America to have a one-month prescription.”
In response, DEA Administrator Chuck Rosenberg said, “I think we’re part of the problem.” Hopefully now, the DEA becomes even more a part of the solution.