Half of New York Overdoses Blamed on Fentanyl

By Pat Anson, Editor

Nearly half of the overdose deaths in New York City since July have been linked to fentanyl, according to a new report that adds to the growing body of evidence that illicit fentanyl is now driving the nation’s opioid epidemic – not prescription pain medication.

In an advisory sent to healthcare providers, New York’s health department said 47 percent of the city's confirmed overdose deaths since July 1 have involved fentanyl. That compares to 16% of overdoses involving fentanyl in all of 2015. So far this year, 725 people have died from drug overdoses in New York.

“Data suggest that the increased presence of fentanyl is driving the increase in overdose fatalities,” the alert said. “While fentanyl is most commonly found in combination with heroin-involved overdose deaths, fentanyl has also been identified in cocaine, benzodiazepine, and opioid analgesic-involved overdose deaths.”

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. Because of its potency, healthcare providers are being warned that additional doses of naloxone – which reverses the effects of an opioid overdose – may be needed when fentanyl is involved.

Fentanyl is available legally by prescription in patches and lozenges to treat more severe types of acute and chronic pain, but illicitly manufactured fentanyl has become a scourge across the U.S. and Canada, where it is often mixed with heroin and cocaine or used to make counterfeit pain medication.

Unsuspecting buyers, including some pain patients who were unable to get opioid medication legally, often have no idea the drug they’re getting from a dealer or friend could contain a lethal dose of fentanyl.

dea image of fentanyl

In addition to New York City, several states in the Northeast and Midwest have reported that fentanyl is now involved in about half of their overdose deaths.

The sharp increase in fentanyl-related deaths has coincided with new restrictions on the prescribing of opioid pain medication. In the past year, the Drug Enforcement Administration has issued two public safety alerts about fentanyl, but the Centers for Disease Control and Prevention has remained relatively quiet about the problem – focusing instead on opioid prescribing guidelines that were released in March of this year.  

Those guidelines have led many doctors to reduce doses or stop prescribing opioids altogether, but they have failed to make a dent in the number of Americans dying from overdoses. There have also been anecdotal reports of a rising number of suicides by patients unable to get opioid medication.

“I know five people who have committed suicide from being denied pain medication by doctors after the CDC came out with their ridiculous statements of the ‘epidemic’ of prescription opioid use,” says Nina Stephens, a Colorado woman who suffers from chronic pelvic pain. 

“Doctors are so afraid of getting in the middle of this epidemic mess with the FDA that they have decided to stop prescribing opioids to their patients, even those patients who are in desperate chronic pain. We are now treating our patients worse than dogs when it comes to pain.”

Stephens says she has to drive 4 hours each month to see a doctor who is still willing to prescribe opioids. A local pain management doctor just 20 minutes away said he would take Stephens off opioids and give her epidural injections instead, which she refused.

“I am truly afraid that soon I will have to drive even farther to find a doctor who will still be willing to prescribe pain pills to me each month or I will have to start looking at the black market.  Maybe a veterinarian would be willing to start treating me?  No wonder the suicide rate is going up so dramatically!” Stephens wrote in an email to PNN.

Canada’s Fentanyl Crisis

Counterfeit fentanyl pills started appearing in British Columbia about two years ago and have since spread throughout Canada. The fentanyl crisis is so severe a two-day conference was held in Calgary this week for healthcare providers and law enforcement.  There were 153 deaths associated with fentanyl in Alberta province during the first six months of 2016.

Some attendees want Alberta to declare a public health emergency – as British Columbia did in April. But Alberta’s Minister of Justice says the current fentanyl situation doesn’t warrant such a declaration.

“None of those powers will assist us in this case but they do give the government a significant ability to violate civil liberties,” said Kathleen Ganley. “We think it’s important we use those powers that have significant impact on Albertans only where they would be helpful to us.”

On display at the conference was an illegal pill press seized by law enforcement that is capable of producing 6,000 fentanyl laced pills per hour.

“Some of the tablets we’ve been seizing in Calgary have ranged from 4.6 milligrams to 5.6 milligrams per tablet—which is very high obviously, considering a lethal dose is two milligrams,” said Calgary police Staff Sgt. Martin Schiavetta in Calgary Metro.

Trump and Clinton Pursue Same Policies in Pain Care

By Pat Anson, Editor

Chronic pain patients hoping for a dramatic change in federal pain care policies as a result of the presidential election are likely to be disappointed.

Both Donald Trump and Hillary Clinton favor more restrictions on opioid prescribing, as well as expanded access to addiction treatment programs, which are essentially the same policies being pursued by the Obama administration.

At a rally in New Hampshire this weekend, Trump outlined for the first time his strategy to combat the nation’s so-called opioid epidemic.

“DEA should reduce the amount of Schedule II opioids -- drugs like oxycodone, methadone and fentanyl -- that can be made and sold in the U.S. We have 5 percent of the world’s population, but use 80 percent of the prescription opioids,” Trump said in prepared remarks.

“I would also restore accountability to our Veterans Administration. Too many of our brave veterans have been prescribed these dangerous and addictive drugs by a VA that should have been paying them better attention.”

Trump said the Food and Drug Administration has been “too slow” in approving opioid pain medication with abuse deterrent formulas. And he said he would “lift the cap” on the number of patients that a doctor can treat with addiction treatment drugs.

donald trump

But the Republican nominee seemed confused about the difference between abuse deterrent formulas and addiction treatment drugs like buprenorphine (Suboxone).

"The FDA has been far too slow to approve abuse-deterring drugs. And when the FDA has approved these medications, the rules have been far too restrictive, severely limiting the number of authorized prescribers as well as the number of patients each doctor can treat," he said.

There are no limits on doctors for prescribing abuse deterrent drugs, but there are for the buprenorphine. In August, the Obama administration nearly tripled the number of patients that a doctor can treat with buprenorphine.

Trump also seemed unaware that the DEA recently said it would reduce the production quota for many opioids by 25 percent or more.

Trump claimed the Obama administration has worsened the nation’s drug problem by commuting the sentences of drug traffickers and by releasing “tens of thousands” of drug dealers early from prison. He also pledged to stop the flow of illegal drugs into the country.

“We will close the shipping loopholes that China and others are exploiting to send dangerous drugs across our borders in the hands of our own postal service. These traffickers use loopholes in the Postal Service to mail fentanyl and other drugs to users and dealers in the U.S.” said Trump.

“When I won the New Hampshire primary, I promised the people of New Hampshire that I would stop drugs from pouring into your communities. I am now doubling-down on that promise, and can guarantee you – we will not only stop the drugs from pouring in, but we will help all of those people so seriously addicted get the assistance they need to unchain themselves.”

Like Trump, Hillary Clinton has also promised to expand access to addiction treatment, but in more detail. Her Initiative to Combat America's Deadly Epidemic of Drug and Alcohol Addiction would allocate $10 billion in block grants to states to help fund substance abuse programs.  

Clinton also wants doctors to undergo training in opioid prescribing before they are licensed to practice and to require that they consult prescription drug databases before writing prescriptions for controlled substances.

One area where Clinton differs with Trump is that she puts less emphasis on law enforcement. Saying she wants to “end the era of mass incarceration,” Clinton has called for low-level drug offenders to get treatment and not just be locked up.

“For those who commit low-level, nonviolent drug offenses, I will reorient our federal criminal justice resources away from more incarceration and toward treatment and rehabilitation. Many states are already charting this course — I will challenge the rest to do the same,” Clinton wrote in an op/ed published in the New Hampshire Union Leader.

hillary clinton

In their public statements, neither Trump or Clinton have given any indication that they believe that  federal policies affecting pain care, such as the CDC’s opioid prescribing guidelines, have gone too far. If anything, they want to go further.

Clinton has endorsed a proposed tax on opioid pain medication sponsored by West Virginia Sen. Joe Manchin (D). If approved, the so-called Lifeboat Act would raise $2 billion annually to fund addiction treatment programs. The tax would be the first federal tax on a prescription drug ever levied on consumers.  

During a roundtable discussion about opioid overdoses in West Virginia, Clinton called the tax “a great idea” and said it was “one of the reasons why I am such an admirer of Sen. Manchin.”

Pain News Network has asked the Trump campaign where the Republican nominee stood on the opioid tax. We have yet to get a response.

Tips for Managing Your Meds

By Barby Ingle, Columnist

When it comes to managing medication, the more you know about your medical condition the better equipped you’ll be to understand which drugs to take, the side effects to watch for, and when to take them. It is also a great idea for your caregiver to know.

There are many times when I am not doing well and my husband will say, “You seem dizzy. Have you taken XXX yet? When was the last time you took it?”

Or he’ll say, “We are going to go out later to get groceries, so take your pill now so you won’t be sleepy when we go and you will be more comfortable.”

Having someone there to help me is great, because sometimes I feel so awful that I cannot remember to take my medication or even what I have taken. I have overdosed on different medications a few times because I forgot I had already taken a dose.

Here are some tips I’ve learned to manage my medications safely:

1)  Use a pill organizer to keep track of your medications. I have a pill box for a two week supply separated into morning and night pills.

2)  Keep medications without childproof caps away from children or lock them up, especially if you have opioid pain medications.

3)  Take your pills at the same time each day, especially when medications are time-released versions. This helps to keep the level of medication consistent in your body.

4)  Know why you are taking each medication, how best to take them (before or after eating), and any side effects that you may experience. Find out what your doctor wants you to do for each medication and verify it with your pharmacist.

5)  Be sure to never break or split time-release pills. Breaking the seal can be very dangerous as your body can receive the dose of the whole pill too quickly and it can become deadly.

6)  Carry a list of your medications and doses at all times in your purse or wallet. You should also update your pharmacy records to include all of the drugs that you take, including any over-the-counter medications. I use Walgreen's and they have a great online site that allows me to update it from home.

7)  Do not drive under the influence of medication that affects your cognitive thinking. It is also a good idea not to drive while taking medications that cause drowsiness or when you are distracted by pain.

8)  If a medication is making you sick or causing side effects that you cannot tolerate, talk to your physician about adjusting the dose or changing the medication. If side effects include trouble breathing, a rash or more severe symptoms, head to a local emergency room for immediate assistance.

9)  Read prescription labels and inserts carefully. They contain important information such as the medication’s name, dosage, prescribing doctor, and expiration dates. This can help you avoid taking a medication for too long or having adverse effects from long-term use.

10)  If you are a drinker, be sure to discuss with your provider or pharmacist if it is safe to drink with any of the prescriptions or over-the-counter medications you are taking.

11)  If you have more than one doctor prescribing medications, be sure to tell all of them what you are taking, so they can be alert to possible interactions and complications. I had to do this for myself and have not had these issues since.

12)  If you decide you no longer want to continue a medication, get your provider’s guidance before you stop taking it. Some medications can be stopped immediately, but many require you to titrate or taper off them.

13)  If you discontinue a medication, be sure to dispose of it properly and immediately. You should also dispose of medication once the expiration date has passed. The FDA has a list of disposal recommendations you can see by clicking here.

Some medications such as inhalants have hazardous material disposal requirements. Follow the specific disposal instructions on the drug label. If no instructions are given, you can crush and mix medications with coffee grounds, cat litter, or food scraps. Then seal them in a bag or a container (such as a margarine tub or jar) and discard them in the regular trash.

Many pharmacies and law enforcement agencies have “Drug Take Back” events that you can participate in. Find out more from your local pharmacist or police station.

Following these tips will keep you, your loved ones and your community safer.

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Chronic Pain Patients to Rally at White House

By Pat Anson, Editor

Only a few months are left in the Obama administration -- and much of the nation’s attention is focused on the bruising battle between Hillary Clinton and Donald Trump over who will be the next president.

But some activists in the pain community are determined to make some noise of their own. They’re planning to hold a Rally Against Pain on the Ellipse south of the White House on Saturday, October 22.

The goal is to draw attention to the millions of chronic pain sufferers who are losing access to opioid pain medication because of a series of actions by the Obama administration to restrict opioid prescribing as a way to fight the national epidemic of drug abuse and addiction.

“We kind of feel like it was this administration that made this mess,” says Lana Kirby, a Florida paralegal, chronic pain sufferer and patient advocate who organized the rally.

“I mean the harm that is happening every single day. For them to let it go and know that it’s going on, to let it go anyway and leave it for the next administration, that’s not the right thing to do.”

Since the Centers for Disease Control and Prevention released it opioid prescribing guidelines in March, Kirby says many patients she counsels in support groups have had their doses reduced or cutoff entirely. Some have been abandoned by physicians who are no longer willing to treat pain patients because they fear harassment or prosecution for prescribing opioids.   

“It’s just one story after another. You can’t really offer these people any hope or help,” says Kirby. “Just about everybody I know in at least 50 percent of the states have either had their medicine discontinued or cut back to minimal levels.

“The way things keep going with all these restrictions, you wonder where it is going to end and what their overall plan is.”

The biggest jolt to the pain community may be yet to come. The Drug Enforcement Administration recently announced plans to reduce the production of hydrocodone, oxycodone and many other opioids by 25 percent or more in 2017. As PNN has reported, some experts in hospice care are worried the cuts could be so severe that terminally ill patients may not be able to get the pain medication they need.

Publicly, the DEA claims the cuts are necessary because of declining demand for opioids. But patient advocates say the real decline is in opioid prescribing -- not in demand -- and the administration is ignoring the impact its policies are having on pain sufferers.

“They only tell you what they want the public to hear because they want the general public to be against opioids of any kind. And they’re doing it very successfully,” says Kirby.

“No other president in American history has done more to destroy the hopes, lives and natural rights of people in pain then President Obama and his administration,” says David Becker, a social worker and patient advocate who will be one of the speakers at the October 22 rally.

“The FDA, CDC, DEA, and DHHS have made it clear that we are not qualified to have an opinion about pain care or our own good. They are as tyrannical as any despot ever was,” adds Becker. “The people involved with the Rally Against Pain are feeling the moral shock that leads to social movements and social movement organizations. We stand with Lincoln in knowing that silence is sin when protest is needed.”

Kirby is expecting about 300 protestors to appear at the rally – a small number compared to the estimated 100 million Americans who suffer from chronic pain. She says many supporters who want to attend are disabled or in too much pain to make the trip.

The rally was organized by volunteers through Facebook and other social media without the participation of well-funded advocacy groups like the U.S. Pain Foundation and the American Chronic Pain Association. Even so, it could turn out to be largest protest ever held by pain patients.

Kirby says she didn’t want to hold the rally next year -- after the new administration takes office -- because too many pain patients are suffering or even suicidal.

“More people will be gone by then. More people will not be functioning. Things are only going to get worse. If we don’t do something and get some attention right away, things are going to be very bad,” she said.

For more information about the rally and how you can participate, click here.

The VA’s Opioid Policy Hurts Veterans Like Me

(Editor’s note: In 2015, Congress passed and President Obama signed into law legislation that requires the Veterans Administration to adopt the CDC’s “voluntary” opioid guidelines, which discourage the prescribing of opioids for chronic pain. Over the past year, the VA has implemented the guidelines throughout its healthcare system, which provides medical services to 6 million veterans -- over half of whom suffer from chronic pain. One of them is Ron Pence.)

By Ron Pence, Guest Columnist

I am a Vietnam veteran who turned to the VA health system in 2001, when I started having pain from polymyositis and chronic arthritis, the worst kind of arthritis caused by autoimmune disease. My own body was attacking my joints and muscles. They said CPK enzyme levels in my blood were very high and in danger of shutting down my kidneys.

Back then the VA cared about vets. I was started on pain meds and they moved me up the ladder as the pain increased.

The head of rheumatology started me on morphine because he said it was the only drug he had to offer. He was right. After 3 pain management visits, 3 more doctors agreed I was on the correct needed dose. X rays of the arthritis in my back ruled out chiropractic care.

I was on the same dose of morphine for 9 years. It worked well enough for me to function and to live alone. The VA promised to continue my opiate therapy as long as I did not break their rules.

After 5 years or so they came out with a new contract and forced us to sign it. I was told either sign it or you don’t gets your meds. I was never accused of breaking their rules and never have. I pointed out the new contract was totally in favor of the VA doing as they please and was signed under duress.

RON PENCE

Now out of the clear blue they cut my dose in half over two months and they may cut it completely because I refuse to take terrible and dangerous psychiatric drugs with the worst side effects. Just search the Internet for “Cymbalta side effects” and you’ll see what I mean.

The VA is really pushing these drugs that I would not give to a dog. They are a lobotomy in a pill. I WILL DIE BEFORE TAKING THEM. They take away your ability to think, speak and make decisions; and come with side effects such as permanent blindness, kidney stones and suicide, even in non-depressed people with no mental problems. Even trying to get off this drug under a doctor's care can end in death for some people. Besides that, it’s nothing more than a sugar pill for the pain.

Why start something like that when what I was taking had no side effects for me and was working fine? I am sure the pills they are pushing will end in a lot more deaths and terrible disabilities and suffering.

My companion almost died after taking Enbril. The VA doctors write prescriptions for Enbril, Humira, etc. as if they were candy. Four shots a month cost $2,000. Far more dangerous than opiates, but someone lines their pockets and the drug companies make over $10 billion a year on them. There is more here than meets the eye.

The CDC in Atlanta says their opioid prescribing guidelines are just that, guidelines. Doctors at the VA must not be smart enough to know what a guideline is. They’re pushing very dangerous, expensive and destructive drugs to replace opioids. Pray and try to find a substitute that works. Doctors sit and lie about what the guidelines say. The stress of not knowing if you are going to be cut off completely is as bad as the pain.

Since the big cutback in my pain medication, I am far less functional. Just standing up 30 seconds to snatch my clothes out of the washer puts me in hollering pain and I fall back into my wheelchair. Cutting the meds even makes it hard to get on the toilet. I am 70 and live alone. My family brings me food to keep me from starving most of the time. I have lost over 90 pounds.

This is going to mean the nursing home for a lot of people like me and I cannot stand the thought of living or existing in a nursing home. Karma is going to get a lot of people making these bad decisions.

I don’t take complaints to Washington because I am old and an 8 mile trip to Walmart wipes me out for a couple of days. This is a fight for the younger guys.

We are in one of the most advanced countries in the world medically, yet the doctors and politicians will not use that knowledge to ease pain and suffering. We have to find a solution.

Ron Pence lives in Florida. Ron enlisted in the Air Force in 1963 – at the age of 17 -- and served his country for 6 years.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

DEA Opioid Cuts Could Affect Terminally Ill Patients

By Pat Anson, Editor

Steep cuts in the production of opioid pain medication planned by the U.S. Drug Enforcement Administration could worsen drug shortages and affect pain patients receiving end-of-life hospice care.

“Yes, I think that’s absolutely possible. And very, very concerning,” says Judi Lund Person, VP of Regulatory and Compliance for the National Hospice and Palliative Care Organization.

The DEA announced earlier this week that it is reducing production quotas for almost every Schedule II opioid pain medication next year by 25 percent or more. The quota cuts include opioids such as hydrocodone, oxycodone, fentanyl, hydromorphone and morphine – many of which are used to give pain relief to patients in palliative and hospice care.

The DEA said the cuts are needed to prevent the diversion and abuse of opioids, and because opioid prescribing has been in decline for several years.

But Person says some patients in palliative care – who are generally disabled and chronically ill, but still living at home  – are already having trouble getting their opioid prescriptions filled.

“We’ve had patients who’ve had a lot of trouble finding a pharmacy that carries certain opioids,” she said

Person is worried that the DEA’s production cuts will also make it difficult for hospices to obtain opioids for terminally ill patients. Her organization, which represents about 4,000 hospice facilities in the United States, is still examining the possible impact of the opioid cuts.

“What does that do for patients at the end of life who need these drugs? That, I think, is one of our biggest questions,” Person told PNN.

“Living and working in the Washington area, the pressure is on so much around the opioid addiction crisis, and looking for any and all opportunities to see if we can correct that. It doesn’t surprise me in any way that this is happening. Now, what we’ll do about it and how we switch over to other drugs that will be available is a completely different question. I don’t know what we’ll do.”

Person says there are 1.4 million Medicare patients in hospice care and several million more receiving palliative care.

Many chronic pain patients who are not in palliative or hospice care say opioids are already hard to get, because many doctors are reluctant to prescribe them and some pharmacies claim they’re out of stock.

“I am really, really scared about my future and others. So many others are already suffering needlessly. How many more are going to be thrown under the bus?” asks Rich Martin, a Nevada pharmacist who was forced into early retirement by chronic back pain. “I take hydrocodone for my rescue doses, 5 times a day, and I almost always use them unless I am totally sedentary. I think hydrocodone is being reduced by 36 percent. 

“Opioids across the country have already been reduced or stopped parabolically downward. This whole quota thing could collapse to where there is indeed inadequate opioids for treatment of legitimate pain patients.  Then pharmacies may actually be telling the truth when they say they are out of opioids.”

The DEA says its opioid quotas are sufficient to provide “adequate and uninterrupted supply for legitimate medical need,” and could be adjusted if problems develop.

“DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls,” the DEA said in a press release.

“This is a step in the right direction,” Sen. Dick Durbin (D-Illinois) said in an interview with WGN Radio. Durbin was among a group of senators that urged the DEA to lower the quota for opioids.

“Clearly there is more (opioids) than is necessary to alleviate pain. I’m the glad the DEA stepped up. It’s the first time.”

GAO Questions DEA’s Competency

Many Americans may not be aware of the significant role DEA plays in regulating the nation’s drug supplies. Drug manufacturers apply to the DEA every year to produce opioids and other controlled substances, and the agency determines how many – the quota – each drug maker can produce.

But in a recent series of highly critical reports, a congressional watchdog agency questioned the DEA’s competency in regulating pharmaceutical drugs.

In March 2015, the DEA was criticized in a lengthy report by the Government Accountability Office (GAO) for its inability to deal with drug shortages, a problem so serious it was called “a risk to public health.”

The GAO said that between 2001 and 2013, there were 87 “critical” shortages of controlled substances, over half of them pain relievers. There were also shortages of anti-anxiety medications, sedatives, and stimulants. 

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the GAO report states.

A second GAO report in July 2015 faulted the DEA for heavy-handed tactics during pharmacy investigations. Many pharmacists said they were worried about being fined or having their licenses revoked, and blamed the DEA for poor communication and unclear rules. 

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report said. 

What has the DEA done in the last year to correct these problems? 

Of the 11 recommendations made by the GAO to improve the quota system and prevent drug shortages, the DEA has fully implemented only two of them.

One of the problems the DEA failed to address is the timeliness of its release of production quotas. Under guidelines set in 2006, the DEA is supposed to set quotas for controlled substances on or before May 1 of each year, to give drug manufacturers enough time to adjust their production schedules for the following year.

“DEA officials attributed this lack of compliance to inadequate staffing and noted that the agency’s workload with respect to quotas had increased substantially,” the GAO said in a report this summer.

“We could not confirm whether DEA’s lack of timeliness in establishing quotas had caused or exacerbated shortages because of concerns about the reliability of DEA’s data, among other things. However, by not promptly responding to manufacturers’ quota applications, we concluded that DEA may have hindered manufacturers’ ability to manufacture drugs that contain schedule II controlled substances that may help prevent or resolve a shortage.”

The quotas for 2017 were released on October 5 -- the 10th straight year that DEA has missed the quota deadline.

DEA Cutting Opioid Supply in 2017

By Pat Anson, Editor

It’s going to get even harder for chronic pain patients in the United States to get prescriptions refilled for hydrocodone, oxycodone, morphine and other opioids classified as Schedule II controlled substances.

The Drug Enforcement Administration has announced plans to reduce the amount of almost every Schedule II opioid pain medication manufactured in the U.S. by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, is being reduced by a third.

The DEA’s order, which is being published in the Federal Register, comes just seven months after the Centers for Disease Control and Prevention released guidelines that discourage primary care physicians from prescribing opioids from chronic pain. The guidelines have had a chilling effect on many patients and their doctors, who have reduced opioid doses or stopped prescribing them altogether.

Opioid prescribing was falling years before the CDC and DEA acted. According to IMS Health, hydrocodone prescriptions in the U.S. plunged by 22 percent from nearly 120 million in 2014 to 93.5 million in 2015.

The “established quota” for hydrocodone in 2017 is being reduced to 58.4 million prescriptions under the DEA order.

“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,” the DEA said in a press release.

“Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those companies that apply for it.  DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls.”

The DEA has been under growing political pressure to reduce the supply of opioids. A group of U.S. senators sent a letter to the agency this summer demanding that opioid quotas be reduced.

“We urge DEA to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic,” said the letter from Senators Dick Durbin (D-IL) Sherrod Brown (D-OH), Edward Markey (D-MA), Amy Klobuchar (D-MN), Angus King (I-ME), and Joe Manchin (D-WV).

“Fourteen billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills. Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA.”

Although opioid pain medication is routinely blamed by politicians, federal agencies and the media for the nation’s so-called opioid epidemic, recent studies in several states have found that most drug overdoses are actually caused by illegal opioids such as heroin and bootleg fentanyl. There are also increasing signs that pain patients unable to get opioids legally are turning to pain medication sold on the streets, some of it counterfeit and laced with fentanyl.

Efforts to restrict the supply of opioids may only be making things worse.

Law enforcement agencies in West Virginia recently said a federal crackdown on opioids – dubbed the Bluefield Pill Initiative -- may have contributed to a recent spike in heroin cases, according to the Bluefield Daily Telegraph.

“We are seeing an increase in heroin because pills are in fewer quantity,” said Sgt. J.S. McCarty, who heads a local crime task force. “Without pills an opioid addict’s only choice is heroin.”

Researchers Identify Riskiest NSAIDs

By Pat Anson, Editor

The risk of non-steroidal anti-inflammatory drugs (NSAIDs) contributing to cardiovascular disease has been known for decades. But now we have a better idea which NSAIDs cause the most risk.

A large study published in the British Medical Journal found that use of any NSAID was associated with a 20 percent higher risk of being hospitalized with heart failure. Seven NSAIDs were found to be the riskiest, depending on the dose taken:

• diclofenac
• ibuprofen
• indomethacin
• ketorolac
• naproxen
• nimesulide
• piroxicam

In addition, two COX 2 inhibitors -- etoricoxib and rofecoxib – were also associated with a higher risk of heart failure.

“Our study, based on real world data on almost 10 million NSAIDs users from four European countries, provides evidence that current use of both COX 2 inhibitors and traditional individual NSAIDs are associated with increased risk of heart failure. Furthermore, the magnitude of the association varies between individual NSAIDs and according to the prescribed dose,” researchers reported.

The risk of heart failure doubled for people taking diclofenac, etoricoxib, indomethacin, piroxicam, or rofecoxib at very high doses. But even medium doses of indomethacin and etoricoxib were associated with increased risk. 

NSAIDs are used to alleviate pain and reduce inflammation, and are found in a wide variety of over-the-counter products – from headache relievers to cold and flu remedies. They are used in so many different products -- such as Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

An editorial in BMJ faulted the study for not going into more detail on the absolute risk between different NSAIDs.

“Information on absolute risks is valuable for clinicians and patients evaluating the balance between benefit and harm of treatment. Low risk patients might accept the small additional risk associated with treatment while higher risk patients might prefer to consider alternative treatments,” said Gunnar Gislason and Christian Torp-Pedersen, who are both professors of cardiology in Denmark.

“In some patients other pain treatments, such as paracetamol (acetaminophen) or a weak opiate, might be a good choice. For patients who do need NSAID treatment, it is important to consider the different risk profiles of the individual drugs. The selective COX 2 inhibitors and diclofenac have repeatedly been associated with higher cardiovascular risk, and therefore it seems prudent to avoid them and consider lower risk naproxen at the lowest effective dose.”

Several previous studies have found that NSAIDs increase the risk of cardiovascular disease and other health problems, but the exact cause has been unclear. A recent study at the University of California, Davis, found that NSAIDs reduced the activity of cardiac cells and led to cell death.

The European Society of Cardiology already recommends limited use of NSAIDs by patients who are at increased risk of heart failure. Those already diagnosed with heart failure should refrain from using NSAIDs completely.

Last year the U.S. Food and Drug Administration ordered warning labels for all NSAIDs to be strengthened to indicate they increase the risk of a fatal heart attack or stroke. The FDA said studies found the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

100 Million Pain Pills Unused After Dental Surgery

By Pat Anson, Editor

Over half the opioids prescribed to patients following dental surgery go unused, according to a small study by researchers who say the leftover pills could be abused or stolen by friends and family members.

Researchers affiliated with the University of Pennsylvania’s Perelman School of Medicine and School of Dental Medicine followed 79 patients who had their wisdom teeth removed or some other type of surgical tooth extraction. Seventy-two of them were given opioid pain medication after the surgery.

On average, patients received 28 opioid pills and – three weeks later -- had 15 pills (54%) leftover. Only five patients used all of the prescribed pills.

From that small sample, researchers project that as many as 100 million excess pain pills are prescribed annually by dentists.

 “When translated to the broad U.S. population, our findings suggest that more than 100 million opioid pills prescribed to patients following surgical removal of impacted wisdom teeth are not used, leaving the door open for possible abuse or misuse by patients, or their friends or family,” said lead author Brandon Maughan, MD, an emergency physician and health services researcher at The Lewin Group, a health policy consulting firm.

“Given the increasing concern about prescription opioid abuse in the United States, all prescribers – including physicians, oral surgeons and dental clinicians – have a responsibility to limit opioid exposure, to explain the risks of opioid misuse, and educate patients on proper drug disposal.”

Twenty-four hours after surgery, patients in the study reported an average pain score of 5 out of 10 while taking pain medication. By the second day, more than half (51%) reported a low pain score (0-3 out of 10), and by the fifth day, almost 80 percent had a low pain score.

“Results of our study show within five days of surgery, most patients are experiencing relatively little pain, and yet, most still had well over half of their opioid prescription left,” said co-author Elliot Hersh, DMD, a professor in the department of Oral & Maxillofacial Surgery and Pharmacology at Penn Dental Medicine.

“Research shows that prescription-strength NSAIDs, like ibuprofen, combined with acetaminophen, can offer more effective pain relief and fewer adverse effects than opioid-containing medications. While opioids can play a role in acute pain management after surgery, they should only be added in limited quantities for more severe pain.”

The study, published in the journal Drug and Alcohol Dependence, also found that drug disposal kiosks in pharmacies and small financial incentives may encourage patients to properly dispose of their unwanted pain medication.

Patients in the study received a debit card preloaded with $10. If they completed surveys assessing their pain and medication use after surgery, they received an addition $3 credit on the debit card. Patients who completed a follow-up health interview received an additional $10.

Patients were also provided with information about pharmacy based drug disposal programs, which led to a 22% increase in the number of patients who had either disposed or planned to properly dispose of their leftover opioids.

“Expanding the availability of drug disposal mechanisms to community locations that patients regularly visit – such as grocery stores and retail pharmacies – may substantially increase the use of these programs,” Maughan said.

Reducing the excess prescribing of opioids for acute pain is one of the goals of the Centers for Disease Control and Prevention. The CDC's prescribing guidelines state that three days or less supply of opioids “often will be sufficient” for acute pain caused by trauma or surgery, and that 7 days supply “will rarely be needed.”  Those guidelines, however, were developed for primary care physicians, not dentists.

Survey: Kratom ‘Very Effective’ for Chronic Pain

By Pat Anson, Editor

Chronic pain sufferers often struggle to find a treatment that works. Opioids dull the pain, but come with the risk of addiction; drugs like Lyrica and Cymbalta can have unwelcome side effects; over-the-counter pain relievers often don’t work for severe pain; and alternative treatments like massage and acupuncture are not always covered by insurance.

So people experiment and try different things – often settling for something that just takes the edge off their pain.

That brings us to kratom, an herbal supplement largely unknown to most pain patients and their doctors. At a recent pain management conference attended by thousands of practitioners, I could find only a handful of doctors who’d even heard of kratom. I’ll confess I didn’t know much about it myself until a few months ago.

Maybe we should all start paying more attention.

In an online survey of 6,150 kratom consumers by Pain News Network and the American Kratom Association, nine out of ten said the herb was a “very effective” treatment for pain, depression, anxiety, insomnia, opioid addiction and alcoholism.

Less than one percent said it did not help.

This was not a scientific study by any means on the safety and efficacy of kratom. It was an online survey of self-selected kratom consumers, many of them quite upset that the U.S. Drug Enforcement Administration is planning to make the sale and possession of kratom illegal, perhaps as soon as the end of the month.

In a 21-page notice published in the Federal Register, the DEA said kratom does not have "an approved medical use” and “is misused to self-treat chronic pain.”

WAS KRATOM EFFECTIVE IN TREATING YOUR PAIN OR MEDICAL CONDITION?

The agency cited no studies to support its claim that kratom was being “misused” to treat pain, so we decided to ask the people who actually use it:

"Honestly, I was blown away at how good it was for my pain and also had the benefit that it lifted my mood, which was important because of the depression I had been experiencing from the chronic pain."

"This natural approach to pain management has allowed me to work full time as a school teacher and be an actively involved mom. These are things I never thought I would be able to have in my life as a result of debilitating pain from a neurological condition for which there is no medical cure."

"I have acute chronic migraines that, unmedicated, result in pain that is completely debilitating, and at times have landed me in the emergency room with stroke symptoms. Multiple doctors have okayed my use of kratom for pain management, as over-the-counter medicine simply does not work and I cannot take opiates."

"My wife has fibromyalgia and has taken kratom for more than 12 years with no adverse effects. Prior to finding kratom, she had tried all of the medication that was prescribed to her. The prescription medication either didn't work, or the side effects outweighed the benefits. Kratom has been a godsend for my wife and has allowed her to function as a mother of 4 children for more than a decade."

"I have been living with chronic pain from multiple reconstructive foot surgeries for 20+ years. Kratom not only effectively treats my pain, but it enabled me to tell my doctor that I no longer wanted my monthly tramadol prescription."

What pain conditions does kratom work best on? Again, this is not a scientific study, and we don’t have a lot of data for certain conditions. For example, 100% of the people who used kratom for cancer pain said it was “very effective” for them, but we only had 27 respondents who identified cancer as the primary reason they used kratom.

On the flip side, over 1,700 respondents said they used kratom for back pain, so the data is probably more reliable for them. And 92% said kratom was very effective for back pain.  

Percentage Who Rated Kratom “Very Effective” for their Pain Condition

powdered kratom

• 100% Cancer
•   97% Multiple Sclerosis
•   94% Irritable Bowel Syndrome
•   93% Migraine
•   93% Fibromyalgia
•   92% Rheumatoid Arthritis
•   92% Back pain
•   92% Acute Pain
•   91% Lupus and other autoimmune diseases
•   90% Osteoarthritis
•   90% Neuropathy
•   88% Trigeminal Neuralgia
•   79% RSD or CRPS
•   76% Ehlers Danlos syndrome   

Quite a few people said they use kratom for pain conditions we didn’t ask about or discovered that it helped them feel better in unexpected ways:

"I tried kratom for many things and it has worked for all. Toothaches, back and knee pain, sore joints and ligaments, flu symptoms, and insomnia."

"I have had very little back pain since I starting taking kratom to treat it. Three side effects I didn't expect is that it eliminated my restless leg syndrome, reduced my blood pressure to a normal level and significantly reduced my overall cholesterol levels."

"I have found so much relief for my ulcerative colitis and carpal tunnel syndrome from this plant that I fear how my body will respond when I no longer have it."

"I use kratom for severe TMJ disorder and sacroiliac joint dysfunction. I am also a recovering addict, and kratom has helped me stay clean and be the best 4th grade teacher I can be. If I hadn't had kratom to help ease chronic pain and the urge to use, I wouldn't be doing my dream job. I'd probably be in jail without a job, divorced, and possibly even dead."

"Kratom without a doubt helps any part of my body to not be in pain. Not only does it help with pain, it helps with my depression and it helps me get to sleep very easily."

Many also have strong feelings about allowing drug companies to use kratom in pharmaceutical products, which would require approval from the Food and Drug Administration. 

Seven out of ten kratom consumers are opposed to that idea, believing drug makers have conspired with the DEA to make kratom illegal.

"This is big pharma using the DEA to eliminate an all-natural herb that is taking a bite out of their drug selling profits."

"Everyone knows all this has to do with the DEA and big pharma being in each other’s back pockets. Money is the root of all evil and here it shows again."

"I feel that the pharmaceutical companies are behind this. People are weaning themselves from their addictions and those that don't end up overdosing requiring Narcan. That is a lot of money they stand to lose."

"If pharmaceutical companies produce kratom, the cost will probably triple. There will be tremendous red tape in even getting the drug from a doctor."

SHOULD DRUG MAKERS BE ALLOWED TO PRODUCE AND MARKET KRATOM?

To see the complete survey results, click here.

Meanwhile, lobbying efforts continue by the American Kratom Association to get the DEA to postpone its decision to classify the two active ingredients in kratom as controlled substances. Two congressmen, Rep. Mark Pocan (D-Wisconsin) and Rep. Matt Salmon (R-Arizona) are circulating a letter on Capitol Hill urging the DEA to delay enacting its order.

“We hope to see a lot of congressmen and women sign onto this,” says Susan Ash, founder of the American Kratom Association. “The letter asks that the director of the Office of Management and Budget and the acting director of the DEA delay a final decision on the placement of kratom as a Schedule I substance, provide ample time for public comment on this significant decision, and resolve any other inconsistencies with other federal agencies.”

A similar letter is being prepared by a law firm hired by the American Kratom Association. Ash told PNN it’s possible the DEA will not formally act on the scheduling of kratom until well after September 30.   

“When we’ve looked back at some of the other emergency scheduling processes that have happened, we have found that they will say it’s going to happen in 30 days, but it’s usually a few weeks after that. That’s just what’s happened historically. We don’t think September 30 is essentially a firm date, just based on history, but we are prepared in case it is.”

Ash said her organization would seek a restraining order from a judge if the emergency scheduling is implemented by DEA.

Kratom Users Say Ban Will Lead to More Drug Abuse

By Pat Anson, Editor

Kratom is a safe and surprisingly effective treatment for chronic pain and a wide variety of medical conditions, according to a large new survey of kratom consumers. Many say banning the herbal supplement will only lead to more drug abuse and worsen the nation’s opioid epidemic.

The online survey of 6,150 kratom consumers by Pain News Network and the American Kratom Association was conducted after plans were announced by the U.S. Drug Enforcement Administration to classify two chemicals in kratom as a Schedule I controlled substances. Unless the scheduling is postponed, the sale and possession of kratom could become a felony as early as September 30.

The survey findings dispel the myth that kratom is used recreationally like marijuana by people who only want to get “high” or intoxicated. The vast majority say they use the herb in teas and supplements solely to treat their medical conditions.

Asked what was the primary reason they used kratom, over half (51%) said they used the herb as a treatment for chronic pain, followed by anxiety (14%), depression (9%), opioid addiction (9%) and alcoholism (3%). Less than two percent said they used kratom recreationally or out of curiosity.

WHAT IS THE PRIMARY REASON YOU USE KRATOM?

“The survey tells us exactly what we’ve been trying to tell the DEA, lawmakers and the general public. The average kratom consumer is nothing like we are being portrayed as,” says Susan Ash, founder of the American Kratom Association.

“The average kratom consumer is a man or woman in their 40’s, 50’s or 60’s, who is primarily looking for alternatives to pharmaceutical drugs that either didn’t work for them or had side effects that were unbearable. The survey clearly shows the majority of people are using kratom to manage chronic medical conditions.”

Nine out of ten patients (90%) said kratom was very effective in treating their pain or medical conditions.

Asked if they get high from using kratom, three out of four consumers (75%) said no and 23% said “a little.” Only about 2 percent said they get high from using the herb. Many likened the stimulative effect of kratom to a strong cup of coffee.

"I only take enough kratom to take the edge off. I never get high like I did on pills or marijuana. Just a clearer state of being with some pain relief."

"It's not possible to get high from kratom as that's not what it does. It is in the same family as coffee and acts just like coffee."

"It elevates my mood, gives me energy and helps with the pain."

"I was stable at all times with kratom. Sound minded and alert. In no negative way did it affect my ability to function. If anything, it improved that and my overall happiness in life."

CAN YOU GET "HIGH" FROM KRATOM?

While the DEA maintains that kratom poses “an imminent hazard to public safety” and has been linked to several deaths, the vast majority of kratom consumers believe it is safe to use.

Ninety-eight percent said kratom was not a harmful or dangerous substance and 95% said banning the herb will have a harmful effect on society.

Many have strong feelings about what will happen if kratom is made illegal.

"I believe this is incredibly harmful to the thousands of people who have been able to find relief from a huge variety of issues, but especially those treating an opioid addiction. Those people will be forced back to opiates."

"I believe that the ban on kratom will trigger the biggest uptick in opiate-related deaths that we've seen in decades."

"Banning kratom will in no way protect society from an imminent health hazard, but actually push society further into the deadly opiate epidemic that plagues America today."

"It will kill people if they make kratom Illegal."

"We must utilize every tool possible to combat addiction to dangerous drugs, and banning kratom is like cutting off your nose to spite the face: stupid and unproductive."

WILL BANNING KRATOM BE HELPFUL OR HARMFUL TO SOCIETY?

Given a variety of scenarios on what could happen if kratom becomes illegal, two out of three respondents (66%) said kratom consumer would be more likely to become addicted and overdose on other substances.

Over half (52%) predicted that kratom users would be more likely turn to illegal drugs such as heroin and illicit fentanyl.

Half (51%) also said kratom consumers would be more likely to consider suicide.

Asked what they would do personally if kratom is banned, one out of four (27%) said they would seek to buy kratom on the black market – indicating that many are willing to risk being charged with a felony rather than give up kratom. Less than a third (30%) said they would not buy kratom on the black market.

"Making kratom illegal isn't going to stop people from buying and taking kratom."

"People who want kratom bad enough will find it and keep using it."

"I believe kratom consumers are likely to try multiple strategies, but most likely they will go back to whatever they used prior to kratom and there will likely be a black market for illegal consumption because none of these other options can compete with the efficacy of kratom."

"We will all be forced to go back on the very drugs that kratom helped us get off of! It will kill a whole lot of people! It will undoubtedly cause an increase in suicides, overdoses of illegal drugs like heroin and morphine."

"Banning this leaf is equivocal to signing the death certificates of many. You may as well be sticking the needle into many arms."

IF KRATOM BECOMES ILLEGAL, WOULD YOU SEEK TO BUY IT ON THE BLACK MARKET?

Susan Ash of the American Kratom Assocation estimates that between 3 and 5 million Americans have tried kratom. And she thinks the DEA’s attempt to ban the herb may have actually led more people to try it.

“Probably a quarter of a million have tried it since they put this notice out,” Ash said.

To see the complete survey results, click here.

Click here to see a report on the effectiveness of kratom in treating specific chronic pain conditions such as fibromyalgia, migraines and back pain.

Living with Chronic Pain After Being Labeled an Addict

By Patricia Young, Guest columnist

I am writing this article from the perspective of a patient who has chronic back pain and also an unwarranted, doctor-imposed label of “addiction.”

As most people can imagine, having both of these problems -- chronic pain and a substance use disorder -- can be very difficult for a healthcare provider to manage. Imagine though how harmful it is when someone is diagnosed or labeled as an addict and it is not an appropriate diagnosis.

The new polite wording for addiction is "chemical dependence," "substance use disorder" or "opiate dependence."

But these terms are not helpful either, since they have the same meaning to most healthcare professionals, as well as the general public.

To make matters worse, I was totally unaware that this diagnosis was ever made and it was never explained to me that it would be in my medical record. I want to share some of the problems this has caused me.

The first time I thought something was wrong was when I found myself having severe eye pain. I called ahead to the emergency room to make sure they had an eye doctor available to see me and decided to go in when they said they did. Instead, I was examined by a physician’s assistant (PA) after he reviewed my medical records. He looked at my eye from a distance without using any diagnostic equipment, told me I had an infection, and gave me antibiotic drops for it. The eye drops only made the pain worse.

I thought it was odd since I had no eye drainage of any kind and never had such pain before with an eye infection. A few days later I learned I had a herpes sore in my eye. No wonder those eye drops didn’t work!

Not one medical doctor or PA had taken my pain seriously in the ER because I had been labeled as having “drug seeking” behavior. But I did not know that until much later.

At the time I was taking opioid pain medication prescribed by my doctor to treat chronic pain from a lower back injury and two back surgeries. Sometimes I have flare ups of severe pain in my left hip, groin and leg despite the prescribed opiate drugs.

I went another time to the ER in severe pain and was seen by another physician’s assistant. After looking at my medical record, the PA proceeded to tell me to get out of the ER as I lay there on a gurney. My husband and I had no understanding at the time why 3 security guards came and told me to get back in my wheelchair myself or they would pick me up and put me there.

My husband picked me up and we were escorted out the door. I was 59 years old, disabled and was no threat to anyone. It was at that point that I started to wonder what “red flag” was in my medical records to make them treat me like that.

Later I found out what that red flag was. A doctor had written down after one visit that I had a “history of addiction.” This was the first time I became aware of this. I really could not understand why since no medical person had ever said I may have this diagnosis or even mentioned the word “dependency” to me.

I later had to move to Florida from upstate New York because my disability made it hard to cope with harsh winter weather. After the move I had great difficulty finding a new primary care physician. I believe no doctor wanted me as a patient after they saw the diagnosis of “history of addiction.”

We all know how difficult it can be to deal with an individual with a drug addiction. It’s a diagnosis that follows people for a lifetime. Unfortunately, when it is made in error, it is very detrimental and can even be a factor in someone’s death. Not only can there be a huge physical ramification from a diagnosis of addiction, but it can do harm to a person’s mental and emotional health, as well as cause family problems. I know it has affected me that way. The diagnosis evokes many people to make judgements.

I had many angry responses from healthcare professionals in my times of real need. The ones that threw me out of the ER demonstrated their anger by tone of voice, gestures, and curtness. I felt hopeless leaving there and my husband was so stunned he had no words to say. It was a very dark time in my life that is difficult to forget.

It has been suggested to me that I now suffer with post-traumatic stress syndrome and anxiety. Doctors want me to take anti-hypertensive medications daily as a result. This very frustrating and damaging diagnosis has led me to distrust the very physicians I go to for help. My blood pressure is high in their offices but not at home.

I also wrestle now with the problem of feeling as if my reputation has been harmed. I am seen by doctors as untrustworthy and in denial since I disagree with the addiction diagnosis. The very medical system that I worked in for almost 35 years has now mislabeled me and treats me harshly at a time when I need care myself.

I strongly believe there needs to be more understanding within the medical community as well as the public arena about this problem. There is a definite difference between a physical dependence on a substance versus an addiction to it. An addiction diagnosis suggests that one has misused drugs and has a mental disorder.

I have been judged as one of those types of people and it’s wrong. I had many medical professionals come up to me and congratulate me for stopping my pain medication. I thought they were crazy. It was no mental feat to stop taking the drugs, but I must admit my body’s physical reaction was not good. That is normal for someone that has taken opioid pain medicine for a period of time.

It is time we stop hurting and stigmatizing pain patients in this manner. It just makes our pain worse and can even lead to serious mental health problems and in some cases suicide.

Please healthcare providers, make sure your diagnosis is made correctly. I believe that an addiction or dependency diagnosis should only be made by someone who is trained in addiction medicine and who specializes in treating addictive disorders.

Patricia Young lives in Florida.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CDC: Prescription Opioid Abuse Costs $78.5 Billion

By Pat Anson, Editor

A new analysis by the Centers for Disease Control and Prevention estimates the total “economic burden” of prescription opioid abuse in the United States at $78.5 billion a year.

Researchers at the National Center for Injury Prevention and Control – the same agency that oversaw development of the CDC’s controversial opioid prescribing guidelines – analyzed economic data from 2013 associated with opioid abuse, including the cost of health care, lost productivity, substance abuse treatment and the criminal justice system.

“A large share of the cost is borne by the public sector, both through direct services from government agencies, but also through tax revenue that will be lost from reduced earnings. Also, the health care sector bears approximately one third of the costs we have estimated here,” wrote lead author Curtis Florence, a senior health economist at CDC.

Florence and his colleagues estimated that nearly two million Americans abuse or are dependent on opioids. Their study is published online in Medical Care, the official journal of the American Public Health Association.

 "More than 40 Americans die each day from overdoses involving prescription opioids. Families and communities continue to be devastated by the epidemic of prescription opioid overdoses.” said CDC Director Tom Frieden, MD, in a news release.

"The rising cost of the epidemic is also a tremendous burden for the health care system."

Exactly what that burden is is open to conjecture. The researchers admit that some of their data is flawed because they relied on death certificates codes – which often fail to distinguish between deaths associated with prescription opioids and those caused by heroin. Heroin users and prescription opioid users are essentially lumped together – even though heroin users are far more likely to enter the criminal justice system.

In addition, opioids associated with death were considered a sign of abuse even if multiple drugs were involved. No distinction was made if the deaths were accidental, intentional or undetermined.

“Our health care cost estimates used the definition of opioid abuse and dependence identified by ICD-9 diagnosis codes. This definition does not differentiate between prescription opioids and heroin,” said Florence. "We did not attempt to attribute costs to specific drugs if multiple types of drug abuse were reported. This could bias our results if the health care cost impact of abuse and dependence is different between prescription opioids and heroin, or if abuse of prescription opioids alone has a different effect from abuse of multiple drugs,”

The researchers also were unable to distinguish between the “nonmedical” use of opioids by someone who obtained the drugs illegally and those who obtained them legally through a prescription.  

“It is extremely difficult to measure all costs to society from an epidemic. In this case, there are many costs we were unable to measure, such as the reduction in quality of life of those who are dependent,” wrote Florence.

Despite these limitations, the CDC research team said their estimates should be considered by healthcare providers and regulators in deciding whether prescription opioids should be used to treat pain.

“In the ideal case, decision makers could use these estimates when weighing the benefits and risks of using opioids to treat pain, and evaluating prevention measures to reduce harmful use. However, at the present time a full accounting of both the benefits and costs of prescription opioid use is not available,” they wrote.

The CDC estimate of $78.5 billion as the annual cost of prescription opioid abuse is only a fraction of the total cost of chronic pain on society. Using data from 2008, researchers from Johns Hopkins University estimated that the economic cost of pain in the United States ranged from $560 to $635 billion annually.

The CDC’s opioid guidelines discourage primary care physicians from prescribing opioid for chronic pain. Although voluntary, anecdotal reports from patients and doctors suggest the guidelines are being widely adopted by many prescribers. Some states have even adopted the CDC guidelines as official policy or in legislation.

The CDC has released no estimate on the economic impact of its guidelines or on the reduction in quality of life for pain patients who are no longer able to obtain opioids.

Half of Patients Have Trouble Getting Pain Meds

By Pat Anson, Editor

A new survey of chronic pain patients found that over half – 56 percent -- have experienced problems getting access to opioid pain medication, either from a pharmacy or their own doctor. Nearly half of the patients surveyed also said they have contemplated suicide.

“Access continues to be a problem and a growing problem for patients living with chronic pain,” said Jeff Dayno, MD, chief medical officer for Egalet, a pharmaceutical company that conducted the survey along with the American Chronic Pain Association (ACPA).

The online survey of over 1,000 patients was conducted in 2015, before guidelines were issued by the Centers for Disease Control and Prevention that discourage primary care physician from prescribing opioids for chronic pain. Although the guidelines are voluntary, they’ve had a chilling effect on many doctors and pharmacists since their release in March.  

“General practitioners who don’t have as much experience are having somewhat of a knee jerk reaction. Either they’re not prescribing opioids at all or taking a very cautious approach,” said Dayno.

“The broader medical community is backing away from the more effective type of pain medications and opioids specifically, even at the pharmacy level in terms of stocking them and having them available.”

Nearly two-thirds of patients (63%) said their pharmacy carries only a limited supply of pain medication. And nearly four out of ten patients (39%) said their physician no longer prescribes pain medication.

“Since the push to combat prescription medication abuse has risen, so have the number of calls we have received from individuals expressing their frustration about accessing their prescription medications,” said Penney Cowan, founder of the ACPA. “The study found that access really is an issue for individuals; they struggle to find doctors who are willing to treat them, and pharmacies that stock their medication.

“For individuals living with chronic pain, access to medication is vital to functioning in their everyday lives. Doctors would not withhold prescriptions from patients with other medical conditions such as diabetes or heart disease. What’s startling is the high percentage of individuals who have contemplated suicide.”

Forty-seven percent of the survey respondents said they’ve had thoughts of suicide.

“The statistic around patients contemplating suicide, we’ve seen numbers like that in the literature before. And that’s a very concerning and frightening aspect of the impact of limited access to effective pain medications,” said Dayno, who believes the number of patients complaining about access would be even higher if the survey was conducted today.

When asked by Pain News Network if he thought the CDC even considered suicides and other negative consequences on patients when it was drafting the guidelines, Dayno said no.

“I don’t think that dimension was clearly considered in the guidelines. I think it was much more of an evidence based, clinical approach on the pain management side. But the impact of potential barriers to access to these medications was not factored in to that assessment as part of the CDC guidelines,” he said.

A noted expert on pain management says he’s also seen “anecdotal reports” of primary care physicians and pain management specialists dumping pain patients since the CDC guidelines came out.

“I think some doctors are increasingly uncomfortable with continuing to prescribe what has been a higher dose of opioids, uncomfortable with the scrutiny that they’ve gotten, and as a consequence they are discharging patients from clinics, urging them to find care elsewhere,” said Sean Mackey, MD, Chief of the Division of Pain Medicine at Stanford University.

Kratom Petition Reaches Goal, But Now What?

By Pat Anson, Editor

Supporters of a citizens' petition that calls on the Obama administration to reverse a decision that will make the sale and possession of kratom illegal have reached their goal of 100,000 signatures.

But the move is largely symbolic and will probably not prevent the Drug Enforcement Administration from classifying kratom as a Schedule I controlled substance at the end of the month.

The DEA filed notice in the federal register last week for an emergency scheduling of mitragynine and 7-hydroxymitragynine, the two main active ingredients in kratom, which comes from the leaves of a tree that grows in southeast Asia.

Kratom is used in teas and supplements as a natural treatment for pain, depression, anxiety and other medical conditions. The DEA claims kratom is also used recreationally for its "psychoactive effects" and has even been used as a substitute for heroin. Kratom supporters say its no stronger than a cup of coffee.

Under its "We the People" petition rules, the Obama Administration promises to "take action" on an issue whenever supporters are able to gather at least 100,000 signatures online within 30 days.

"We will do our best to respond to petitions that cross the signature threshold within 60 days, however, depending on the topic and the overall volume of petitions from We the People, responses may be delayed," the White House says in a statement on its website.

According to the website whpetitions.info, the average response time for a successful petition is 118 days. Six petitions -- including the kratom petition -- are currently waiting for a response.

Barring a last minute legal challenge, the DEA scheduling of kratom as a controlled substance, alongside heroin, LSD and marijuana, will begin September 30.

"This may go into effect before we get a response from the White House," says Susan Ash, founder of the American Kratom Association, a volunteer organization of kratom users. "That's one of the reasons why we are doing our rally September 13th in front of the White House, so that we can bring this issue to their attention prior to them being required to give us a response."

The Obama administration began hosting "We the People" petitions on the White House website in 2011. Although the petitions have been criticized as a public relations gimmick, some have resulted in federal action, such as legislation allowing consumers to use their mobile devices on any network they choose.

At other times, however, the White House response to a petition has been a statement that only reaffirms current policy. That was the case in 2011, when petitioners asked the administration to legalize marijuana.

"Like many, we are interested in the potential marijuana may have in providing relief to individuals diagnosed with certain serious illnesses," wrote Gil Kerlikowske, Director of the Office of National Drug Control Policy, in the official White House response to the petition.

"That is why we ardently support ongoing research into determining what components of the marijuana plant can be used as medicine. To date, however, neither the FDA nor the Institute of Medicine have found smoked marijuana to meet the modern standard for safe or effective medicine for any condition."

The DEA is taking a similar stance on kratom, saying it has no medically accepted use.