Guideline Paranoia

By Carol Levy, PNN Columnist

I recently posted an article to an online chronic pain support group about the CDC’s opioid prescribing guideline.

“For treating acute pain, the guideline recommends a quantity no greater than what is needed for the expected duration of pain severe enough to require opioids, specifying that three days or less will often be sufficient and more than seven days will rarely be needed,” the guideline states.

It makes sense to me. And I assumed that would be the response my post would get. The recommendation is only for treating acute pain and acute pain shouldn’t need chronic, long term opioid treatment.

Instead, the replies were quick, angry and knee jerk:

“How dare they decide what and how many we need? This will hurt chronic pain patients.”

“They always come after us. These may be for acute pain patients, but you just know more draconian guidelines are just around the corner for chronic pain patients.”

The CDC guideline does not say, “And no one, even if their acute pain continues longer than 3 or 7 days, will be able to get the pain meds they need.” But that was how it was interpreted.

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And then the people replying went one step further: “Soon they will be writing guidelines that even those in chronic pain can only have opioids for a specified period of time and a specific dosage, and not one grain more or one day longer.”

I see this common response and reaction as a major issue. When any new guideline is proposed (and people forget these are guidelines, not absolutes), it is a major catastrophe: “They are coming after us.”

Too often we act in a way that appears akin to addictive behavior. We have to have our opioid medications. And any restriction, even when it is not related to chronic pain, is one restriction too many: “They are going to take away my drugs. Then what will I do?”

We seem to have lost the concept of consideration. No time is taken to think through the new suggestions. Instead it is an immediate jump to: “This will hurt me. I won't be able to get the meds I need.”

For many of us, opioid medication is all that is left or the only option. The idea that someone, especially the government, may rip them from us is truly terrifying.

But I wonder. Maybe if we did not take any and all new guidelines as a frontal attack on us, maybe we would not be seen and referenced so often as a major component and cause of the “opioid epidemic.”

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Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

How Common Is Opioid Addiction?

By Roger Chriss, PNN Columnist

As the opioid crisis continues to worsen, there is increased scrutiny of both prescribing levels and fatal overdose rates. The goal of reducing opioid prescriptions is to decrease the exposure to opioids, on the theory that medical use of opioid analgesics is closely linked with addiction and overdose risk.

But how valid is that theory? A key issue in the crisis is opioid addiction rates, which can be divided into medical and non-medical addiction.

Medical Opioid Addiction Rates

The National Institute on Drug Abuse (NIDA) reports that 8 to 12% of patients on long-term opioid therapy develop an opioid use disorder.

“The best and most recent estimate of the percentage of patients who will develop an addiction after being prescribed an opioid analgesic for long-term management of their chronic pain stands at around 8 percent,” NIDA Director Nora Volkow, MD, told Opioid Watch.

The NIDA estimate is well-researched and widely accepted. But there are other estimates, each with important qualifications.

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Cochrane found in a major review of studies of long term opioid therapy for non-cancer pain that only 0.27% of participants were at risk of opioid addiction, abuse or other serious side effects.

In another large study, The BMJ reported that only about 3% of previously opioid naïve patients (new to opioids) continued to use them more than 90 days after major elective surgery.

Other addiction rates include numbers as low as 1% and as high as 40%. But details matter. Much of the difference in addiction rates stems from three factors:

  1. How well screened the patient population is
  2. How carefully monitored the patients are during opioid therapy
  3. How the criteria for opioid use disorder are applied

In other words, a well-screened and closely monitored population of adults with no risk factors may well have an addiction rate of 1%. The recent SPACE study by Erin Krebs, MD, in which over 100 people with knee osteoarthritis and low back pain were put on opioid therapy for a year, saw no signs of misuse, abuse or addiction. There were also no overdoses.

Non-Medical Opioid Addiction Rates

It’s also important to look at the percentage of people who become addicted to opioids without ever having an opioid prescription. Here the addiction rates are much higher.

A 2009 study in the American Journal of Psychiatry found that among treatment-seeking individuals who used OxyContin, 78% had not been prescribed the drug for any medical reason. The OxyContin was “most frequently obtained from nonmedical sources as part of a broader and longer-term pattern of multiple substance abuse.”  

The 2014 National Survey on Drug Use also found that about 75% of all opioid misuse starts outside medical care, with over half of opioid abusers reporting that the drugs were obtained “from a friend or relative for free.”

Heroin is considered highly addictive, with nearly one in four heroin users becoming dependent. Importantly, most people who try heroin already have extensive experience with other substances, including opioid medication, and many have serious mental illness. There is no research on the addictive potential of heroin in drug-naive people.

Relatively little is known about the complex and concealed world of nonmedical opioid use. Researchers like UCSF’s Daniel Cicerone are working to fill this gap by collecting information on overdoses to get a more accurate picture on the type of opioids being used.  

Risk Management

Opioids remain an essential part of modern medicine, from trauma and battlefield medicine to surgery, end-of-life care and long-term management of chronic, progressive degenerative conditions. This makes risk management vital.

Current tools to screen patients include the long-standing COMM tool and the new NIDA TAPS tool. Novel approaches using genetic testing for opioid risk may eventually help clinicians better assess risk, too. And improved data analytics may also help reduce addiction.

"Understanding the pooled effect of risk factors can help physicians develop effective and individualized pain management strategies with a lower risk of prolonged opioid use," says Ara Nazarian, PhD, a researcher at Beth Israel Deaconess Medical Center.

The Krebs SPACE study achieved an admirable level of safety by carefully screening and monitoring patients during opioid therapy. A similar patient-focused approach that acknowledges the low rate of medical opioid addiction and works to minimize it further is likely to bring benefits to both individuals and society at large.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Mayo Clinic: Opioid Prescribing Has Not Changed

By Pat Anson, Editor

Numerous studies have shown that opioid prescriptions are falling. The trend started in 2011 and appears to have accelerated since the release of the CDC’s 2016 opioid prescribing guidelines.

The volume of opioid medication filled last year fell by 12 percent, the largest decline in 25 years, according to the IQVIA Institute.  Prescriptions for hydrocodone – once the most widely prescribed drug in the country – have fallen by a third since their peak. Even the CDC has reported that opioid prescriptions have dropped by about 5% each year between 2012 and 2016.

Anecdotally, many patients tell us opioids are harder, if not impossible, to obtain. Nearly half of the 3,100 patients PNN surveyed last year said they were getting a lower dose. And one in four said they were no longer prescribed opioids.

But according to Mayo Clinic researchers, opioid prescribing hasn't changed that much and remains at high levels. In a study published in the British Medical Journal (BMJ), they report that opioid prescriptions for Medicare and privately insured patients have remained relatively stable over the past few years. And the average daily dose of opioids is well above what it was 10 years ago.

“If you’re hearing the message that prescription opioid use is starting to decline, I think we need to counter that message and say in most populations it really isn’t moving very much.” says lead author Molly Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Our data suggest not much has changed in prescription opioid use since about five years ago.”

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Why the discrepancy? Jeffrey says most of the previous studies only looked at market-level data – the amount of opioids that drug makers reported producing and selling. She and her colleagues dug a little deeper, looking at insurance claims for 48 million U.S. patients between 2007 and 2016.  

Over that 10-year period, the rate of opioid use by privately insured patients remained relatively flat at 6 to 7 percent. The average daily dose for that group, about two pills of 5-milligram oxycodone, remained the same.

The rate of opioid use by Medicare patients 65 and older peaked at 15% in 2010 and decreased slightly to 14% by 2016. Their average daily dose, three 5 mg pills of oxycodone, also remained relatively unchanged.

Rates of opioid use by disabled Medicare patients also haven't changed much, peaking at 41% in 2013 and falling to 39% in 2016. Their average daily dose remains relatively high, about eight 5 mg oxycodone pills. 

“Our research of patient-level data doesn’t show the decline that was found in previous research,” says Jeffery. “We wanted to know how the declines were experienced by individual people. Did fewer people have opioid prescriptions? Did people taking opioids take less over time? When we looked at it that way, we found a different picture.”

The Mayo study includes an interesting disclaimer. While the researchers looked at data from patient insurance claims, they never surveyed or spoke to any patients about their opioid use. The researchers said they would “engage” with patients in future blog posts and press releases.

You can share your views with Molly Jeffery by email at jeffery.molly@mayo.edu or @mollyjeffery on Twitter.

I Have to Drive 6 Hours for Pain Care

By Bailey Parker, Guest Columnist

I feel so alone and isolated. There have been times I wanted to die, but my 5-year old son keeps me going. I get up every day for him.

About two years after he was born, I had a car wreck. I hit a coyote at 60 mph and ripped the radiator off my car. The doctors told me I had the spine of an 80-year old and needed a double level fusion in my neck.

I was 34 then and in tremendous amounts of pain. But after reading online stories in spine health forums, I was skeptical about the surgery. Everything told me to wait. So I did, for a year. I saw three surgeons and a neurologist. They all told me to have the surgery.

I live in a small city in southwest Colorado. When it comes to opioid pain medication, all the doctors here seem to have taken the stance, “We just don’t do that here.” The nearest city is Albuquerque, New Mexico, which means a 4-hour drive for me across state lines, or a 6-hour drive to Denver over mountain passes.

Before my surgery, one of the doctors of orthopedic medicine prescribed my pain medication. For two months, I was able to work again and was beginning to get back on my feet. I remember thinking at the time that I didn’t want to take medication for the rest of my life, but the fusion sounded worse.

The third month in I called for a refill of my medication. They told me no, but wouldn’t say why or give me a follow up exam with the doctor. He was too busy and couldn’t see me for a month. I waited one excruciating month and went to see him, asking what happened.

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BAILEY PARKER

He had looked at my prescription records and saw a prescription for narcotics from another doctor for when I had cystic fibroids on my ovaries. It was not the same pain medication as what he prescribed me, and I didn’t even know they were the same type of medicine.  

Even though I had a broken neck, he did not feel comfortable prescribing to me anymore. His office then took 6 months to get my medical records sent to my primary care doctor. I had to physically go in and yell at them that I was about to have major surgery. This was the first time I felt treated like an addict, but not the last.

I went to my primary care physician and explained what happened with this other doctor. We have a very good relationship. She knows all of my medical history. She handled my pain medication before my surgery but was very clear that she would not do it for an extended period.

I never take more medication than prescribed. I am not an addict. I do everything they tell me. I was walking and doing yoga every day, just as the doctors recommended. I took my vitamins and a fruit shake every day.

After the fusion surgery, things just didn’t feel right. I was in tremendous pain again and this time there was more of it in different places. I told the physician’s assistant at my surgeon’s office and he told me to just get off all the drugs. He said it would help. He told me I would be fine. I wasn’t.

I struggled for another month before I demanded to see the surgeon. He told me I would benefit from OxyContin and gave me a week’s supply. For the first time since my accident, I was able to work and properly care for my son. My depression lifted. But when I called to tell them that I was doing good on the medication, they said it was time to go back to my primary care doctor and any further medication would have to be prescribed by her.

I went to see her, but she still did not feel comfortable handling my care and referred me to a pain clinic 6 hours away. I was in despair, thinking that I had crippled myself for life and would lose my job, my son and my husband. All of these relationships were strained at this point.

The pain clinic helped me get my life back. They are compassionate and good to the people that come through their doors. It’s a common misconception that pain patients want to take medication. We don’t. We just want some of our lives back and pain medication helps us have that.

A year after my fusion, the surgeon met me again. The fusion had failed, and he wanted to do a revision that would be more painful than the first. He also told me he thought my pain might be caused by fibromyalgia. I’ve never been so angry. I have pain because of my broken neck. Pompous arrogant doctor with no aftercare.

Here is my dilemma, I’ve gotten better care in a big city, where they do not treat me like an addict. I’ve gotten my life back. At first, I was able to go there every three months to get my medication, but with the laws changing, they now say I have to go every month. Driving 6 hours both ways with a 5-year-old and a broken neck is hard. But quality of life and pain are great motivators.

My experience has left me with so much anger towards doctors in my area. It seems their Hippocratic oath has been trumped by the opioid crisis and fear of administrative action. I do not tell people about the medication that helps my quality of life for fear of judgement and stigma. Unless they have been through chronic pain, they simply don’t understand.

I wouldn’t wish this on my worst enemy.

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Bailey Parker lives in Colorado.

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 Adopts Rule to Further Limit Opioid Production

Pat Anson, Editor

The U.S. Justice Department has finalized a new rule that will allow the Drug Enforcement Administration to reduce the amount of opioid pain medication a drug maker can produce if it finds the opioid is being diverted or misused.

The controversial change in the opioid production quota system was adopted despite warnings from patients, doctors and drug makers that it targets the wrong the problem and could worsen shortages of some pain medications.

The DEA maintains the rule change will “encourage vigilance” on the part of opioid manufacturers to prevent their drugs from being abused.

“These common-sense actions directly respond to the national opioid epidemic by allowing DEA to use drug diversion as a basis to evaluate whether a drug’s production should be reduced,” said DEA Acting Administrator Uttam Dhillon in a statement. “This also opens the door for increased communication and better information sharing between DEA and individual states, as we work together to address the opioid problem plaguing our country.”

The final rule greatly enhances the roles played by states and other federal agencies in setting opioid production quotas. It requires DEA to share proposed quotas with state attorneys general, who could object to a quota and demand a hearing.

The rule also allows DEA to consider “relevant information” from all 50 states, the Department of Health and Human Services, Food and Drug Administration, the Centers for Disease Control, and the Centers for Medicare and Medicaid Services, before setting a quota.

"DEA must make sure that we prevent diversion and abuse of prescription opioids. Today's new rule, by taking diversion of these opioids into account, will allow the DEA to be more responsive to the facts on the ground. More importantly, it will help us stop and even prevent diversion from taking place,” said Attorney General Jeff Sessions.

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Sessions announced the proposed rule changes in April, and DEA received over 1,500 public comments during an unusually short comment period. A clear majority opposed the new rule.

“This does nothing to stop addiction or overdose deaths. Addicts will find a high anywhere and where they find it now is street drugs! Illicit drugs are what’s killing, not doctor prescribed opioids filled at a pharmacy. The reporting you all are using is inaccurate and false,” wrote Amy Vallejo.

“By creating quotas, and thereby shortages, you are committing torture,” said Kimberley Comfort, who lives with arachnoiditis, a chronic spinal disease. “There is no reason why people having surgeries, people who suffer from incurable diseases, should be left to suffer when we are a nation that has the ability to take care of its citizens. The DEA does not have a clear understanding of the so-called opioid crisis and therefore needs to cease and desist making opiates harder to get.”

“Again, we have the DEA making laws and quotas on something they should not be. Let them worry about the drugs coming in from China, Mexico etc. which are illegal,” said Sarah Yerxa. “By cutting the quotas all they are doing is sending needy pain patients to the streets, which will just raise the addiction... and overdose problem.”

Opioid Shortages

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25 percent in 2017, followed by another 20 percent cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Many hospitals and hospices now face a chronic shortage of intravenous and injectable opioids, which are used to treat patients recovering from surgery or trauma. The shortage has been primarily blamed on manufacturing problems, although some critics say it has been worsened by the DEA production cuts.

“I believe Attorney General Jeff Sessions needs to sit down and talk to some of these physicians who are pain specialists and understand that what he’s doing is going to put the chronic pain patient, the post-operative patient, and the patient that comes to the emergency room in serious jeopardy,” Tony Mack, CEO and chairman of Virpax Pharmaceuticals, told PNN in an earlier interview.

“I think that Jeff Sessions is not educated well. I think he is picking on something that sounds good politically but doesn’t make sense socially. It’s socially irresponsible.”

In a public notice announcing the rule change, the DEA said it was not responsible for “perceived shortages” of injectable drugs and blamed the “manufacturer induced shortages” on “internal business decisions.”

The agency also deflected criticism that it was targeting the wrong problem. Recent studies indicate that overdoses involving illicit fentanyl, heroin and other street drugs now outnumber deaths linked to prescription opioids.   

“The DEA acknowledges that prescriptions for opioid drug products have decreased over the last several years due to the stepped up civil, criminal, and regulatory enforcement efforts of the agency. However, while there is a downward trend in prescribing, these Schedule II prescription opiates continue to have a high potential for abuse and dependence and require the annual assessment of quotas,” the DEA said.

The agency also claimed prescription opioids were “inextricably linked” to overdoses from heroin and illicit fentanyl, because many addicts start by taking pain medication from family medicine cabinets and then move on to street drugs.

The DEA statement defies some of its own analysis. Less than one percent of legally prescribed opioids are diverted, according to a 2017 DEA report, which also found that admissions for painkiller abuse to publicly funded addiction treatment facilities have declined significantly since 2011, the same year that opioid prescriptions began dropping.

FDA Ends Probe into Kratom Salmonella Link

By Pat Anson, Editor

The Food and Drug Administration has ended its investigation of a small salmonella outbreak linked to kratom – but not without taking some parting shots at the herbal supplement used by millions of Americans to treat chronic pain, addiction, depression and other conditions.

“It appears the salmonella problem with kratom uncovered earlier this year has probably been occurring for some time and is ongoing. We have closed our outbreak investigation, concluding that anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella,” said FDA commissioner Scott Gottlieb, MD, and Stephen Ostroff, MD, FDA Deputy Commissioner for Foods and Veterinary Medicine, in a lengthy joint statement.

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The FDA ended its investigation five weeks after the Centers for Disease Control and Prevention wrapped up its own probe of the salmonella outbreak that sickened 199 people in 41 states. The CDC investigation began in February of this year, but salmonella illnesses linked to kratom were traced back as far as January 2017.

No single source of the outbreak was ever identified, but kratom was considered the “likely source.” A little over half of the 81 kratom samples that were analyzed tested positive for strains of salmonella bacteria.

“This means that users of these products had essentially a one in two chance of being exposed to this pathogen,” Gottlieb and Ostroff said. “The more than 50 percent contamination rate is stunningly high. It represents a level rarely seen in outbreak investigations of this nature. It shows that a high proportion of kratom being shipped into the United States may be contaminated with salmonella.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural pain reliever and stimulant, particularly in rural areas of Indonesia and Thailand.  

“In these locations, the plant is being grown, harvested and processed in problematic conditions that readily create the circumstance for widespread contamination with foodborne pathogens. Although some of the kratom is further processed once in the United States into capsules, powders or herbal remedies, based on our findings, these procedures do not appear to be eliminating microbial contamination,” wrote Gottlieb and Ostroff.

In recent years, millions of Americans have discovered kratom and started buying it online or in convenience stores and “head shops.” But not until this year did federal health officials show any concern that kratom products were contaminated with salmonella bacteria. Their primary focus was that kratom was being marketed as an unapproved medical treatment, particularly for pain and addiction.

The FDA has even started calling kratom an addictive “opioid,” when in reality its active ingredients are mitragynine and 7-hydroxymitragynine, two alkaloids that are believed to act on opioid receptors in the brain. Earlier this year, the FDA released a computer analysis that found kratom contains over two dozen opioid-like substances – a report that critics say was biased and amounted to “junk science.”

Over a dozen kratom products were recalled during the FDA and CDC salmonella investigations. Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in death.

There have been several other salmonella outbreaks this year, including infections linked to melons, raw sprouts, dried and shredded coconut, live poultry, chicken salad, pet guinea pigs, and Kellogg’s Honey Smacks cereal.

FDA Continues Crackdown on Kratom Vendors

By Pat Anson, Editor

The U.S. Food and Drug Administration has stepped up its campaign against the herbal supplement kratom by sending warning letters to three distributors of kratom products – the latest effort in what appears to be a concerted government effort to stop all sales of the herb.

Front Range Kratom, Kratom Spot and Revibe are accused of illegally selling unapproved “drug products” and making unproven claims about kratom’s ability to treatment opioid addiction, chronic pain and other medical conditions.

The FDA and the Centers for Disease Control and Prevention have previously warned consumers not to consume any kratom products. The CDC said kratom was the “likely source” of a small salmonella outbreak, while the FDA alleged that kratom has opioid-like qualities and could lead to addiction and overdose.

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“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“We cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and started using the herb as an alternative to prescription drugs for treating chronic pain, anxiety, depression, and addiction.

Like most herbal and dietary supplements, there is little scientific research to support the use of kratom and it is not approved for any medical condition by the FDA. As a result, many kratom distributors are careful to avoid making unsubstantiated medical claims. Front Range Kratom, for example, currently has a clear disclaimer on its website stating that:

Information on this website is not for health-related guidance. The products mentioned on this website are not intended to diagnose, prevent, treat or cure any diseases or health conditions. You need to consult with a medical practitioner for all issues with regards to your overall health.”

But even sharing customer testimonials about kratom is considered illegal marketing by the FDA. The agency alleges in its warning letter to Front Range Kratom that the website contained comments from new customers such as “Certainly kratom is useful for pain — myself and everyone else on the internet can attest to that.” Another customer wrote that “the two things I think kratom works the best for are pain and to help people get through some of the post acute withdrawl (sic) symptoms they get when they come off of their pain medications.”

Those testimonials from kratom users can’t be found on the website today.

“If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process,” said Gottlieb. “In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms.”

FDA investigators are also monitoring the social media sites of kratom vendors. Last October, Kratom Spot shared on its Facebook page a CNN story about kratom as a possible treatment for pain and opioid addiction. The company only said the story was “positive news for kratom as... an all natural alternative.” But the FDA said that amounted to the illegal marketing of an unapproved drug.

“The claims on your website and social media sites establish that your kratom products are drugs…  because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease—in particular, for opiate withdrawal and addiction,” the warning letter states.

It probably didn’t help that Kratom Spot shared a picture on its Facebook page of hundreds of kratom orders being readied for shipment by another federal agency -- the U.S. Postal Service.

Kratom Spot, Front Range Kratom and Revibe were all given 15 days to respond to the warning letters, which state that “failure to correct violations may result in law enforcement action such as seizure or injunction.”

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KRATOM SPOT/FACEBOOK

The threat of legal action can be all that it takes to drive a kratom vendor out of business. In February, the FDA forced  Divinity Products Distribution to recall and stop selling kratom products. The FDA said the company agreed to the “voluntary destruction” of its kratom products, even though there were no reports of illnesses associated with them.

Sessions Wants More Cuts in Opioid Production

By Pat Anson, Editor

Attorney General Jeff Sessions has proposed further tightening in the supply of opioid pain medication to punish drug makers who allow too many of their painkillers to be diverted and abused.

Under the proposal, the Drug Enforcement Administration – which is overseen by the Justice Department – must consider whether an opioid medication is being misused, abused or causing overdoses when it sets annual production quotas for drug makers.

“The current regulations, issued initially in 1971, need to be updated to reflect changes in the manufacture of controlled substances, changing patterns of substance abuse and markets in illicit drugs, and the challenges presented by the current national crisis of controlled substance abuse,” the DEA said in a notice to be published in the Federal Register.  

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WHITE HOUSE PHOTO

“Under this proposed new rule, if DEA believes that a company’s opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make,” Sessions said. "It’s a common sense idea: the more a drug is diverted, the more its production should be limited." 

The cuts in opioid production could be ordered even if a drug maker has no direct role in the diversion.

"If DEA believes that a particular opioid or a particular company’s opioids are being diverted for misuse, then DEA would be able to reduce the amount that can produced in a given year. These smarter limits will encourage vigilance on the part of opioid manufacturers," the agency said in a statement.

The public has only 15 days to comment on the rule change. Public comment periods in the Federal Register are usually between 30 and 60 days long, with some taking up to 180 days. Agencies are allowed to use shorter comment periods "when that can be justified."

"This shortened period for public comment is necessary as an element in addressing the largest drug crisis in the nation's history," the DEA said. To see the rule change and make a comment, click here. Comments must be submitted on or before May 4.

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25 percent in 2017, followed by another 20 percent cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Last week the DEA said it would allow three drug makers to increase their production of injectable opioids because of shortages that left hospitals scrambling to find effective analgesics to treat patients suffering from acute pain. The shortages of injectable fentanyl and morphine are largely due to manufacturing problems, although some critics say the DEA itself is partly responsible.

DEA ‘Asleep at the Switch’

The proposed rule change was triggered by a lawsuit filed against the DEA by West Virginia, alleging that the current quota system “unlawfully conflates market demand for dangerous narcotics with the amount of legitimate medical needs.”    

“The DEA -- the agency tasked with effectively limiting how many opioid pain pills can be manufactured -- has been asleep at the switch and unwilling to recognize fatal flaws within its own system,” said West Virginia Attorney General Patrick Morrisey. The lawsuit was put on hold after Sessions directed the DEA to change its rules.

Under the proposed rules, the DEA would be required to get input from states, Food and Drug Administration, Centers for Disease Control and Prevention and the Department of Health and Human Services before setting opioid quotas.

Since becoming Attorney General, Sessions has been almost singularly focused on prescription opioids as the cause of the addiction and overdose crisis, even though about two-thirds of all overdoses are caused by black market drugs such as illicit fentanyl, heroin and cocaine. Less than one percent of legally prescribed opioids are diverted, according to the DEA’s own figures.

In February, Sessions said pain sufferers should “tough it out” and take aspirin, rather than turn to opioids for pain relief. "Sometimes you just need to take two Bufferin or something and go to bed," he said.

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WHITE HOUSE PHOTO

Last week, Sessions visited a controversial memorial near the White House that features a wall of 22,000 engraved white pills -- each pill representing the face of someone who supposedly died from a prescription opioid overdose in 2015.

As PNN has reported, the National Safety Council’s traveling exhibit misrepresents the number of Americans who overdosed on pain medication. The CDC recently admitted that its methods for counting overdoses “significantly inflate estimates.”

More misinformation and half-truths are being published in the Federal Register to justify changes in the DEA quota system.  

“(Opioid) users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers or without cost from the family medicine cabinet or from friends. Once ensnared, dependency on potent and dangerous street drugs may ensue,” the notice says.

“About 80% of heroin users first misused prescription opioids. Thus, it may be inferred that current users of heroin and fentanyl largely entered the gateway as part of the populations who previously misused prescription opioids.”  

The notice is referring to a single but often-cited survey, which found that most heroin users in addiction treatment also abused prescription opioids. But experts say most addicts try a variety of different substances – such as tobacco, marijuana, alcohol and illicitly obtained opioid medication – before moving on to heroin. It is rare for a legitimate patient on legally prescribed opioids to make the transition to heroin.  

Memorial Misrepresents Overdoses Linked to Rx Opioids

By Pat Anson, Editor

A provocative memorial to overdose victims makes its debut in Washington DC this week, where it is likely to draw more attention to opioid addiction and the overdose crisis.  

Modeled after the Vietnam Veterans Memorial, the National Safety Council’s traveling exhibit features a wall of 22,000 engraved white pills, each pill representing the face of someone who died from a prescription opioid overdose in 2015. To dramatize the point, a new pill is etched at the exhibit every 24 minutes, to represent how often a person supposedly dies from an overdose of pain medication.

Prescribed to Death: A Memorial to the Victims of the Opioid Crisis has already appeared in Chicago, Pittsburgh and Atlanta, and will be on display at President’s Park near the White House from April 11 to 18.

"We hope that putting a face on the statistics of the thousands lost to this epidemic inspires a greater sense of urgency among all stakeholders to continue their work to eliminate preventable drug overdose deaths," Deborah Hersman, president and CEO of the National Safety Council (NSC), said in a statement. 

NATIONAL SAFETY COUNCIL IMAGE

NATIONAL SAFETY COUNCIL IMAGE

But like nearly everything else having to do with the overdose crisis – the exhibit misrepresents and exaggerates how many people actually died from prescription opioids, while ignoring the larger role played by illegal opioids and other black market drugs, which now account for about two-thirds of all overdoses.  

Twenty-two thousand people did not die from prescription opioids in 2015. According to revised estimates by the CDC, there were 17,536 deaths involving opioid medication that year. And some critics believe the actual number is even lower.

But that’s not stopping the NSC and the White House from promoting the memorial and its false statistics.

"The decision to bring the memorial to Washington is part of President Trump and First Lady Melania Trump's efforts to raise awareness about the crisis and to make us each part of solution," said Kellyanne Conway, counselor to the President. 

An NSC video shared by the White House on its Twitter account claims that “commonly prescribed pain medications are at the root of the crisis” and that “92,000,000 Americans were prescribed opioids in one year. 22,000 of them died from an overdose.”

‘Significantly Inflated’ Estimates

Where does the 22,000 number come from? It was not taken out of thin air or invented -- at least not by the National Safety Council. The NSC says it is based on CDC mortality data from 2015 -- when 22,598 overdoses were initially blamed on opioid pain relievers.

However, as PNN has reported, CDC researchers recently admitted that number and many other overdose estimates are wrong, because they included deaths involving illicit fentanyl and other synthetic opioids that “significantly inflate estimates.”

A more accurate number to blame on opioid pain medication, according to one CDC critic, is 16,610 overdoses – a number that has remained relatively stable over the last few years.  It’s also about 25% lower than the number of pills on display in the NSC exhibit.

When PNN asked the NSC to explain the discrepancy, we were emailed a nonsensical response by a spokesperson that only bends the truth further:

“The number of pills on the wall – 22,000 – represents the number of people who overdosed on prescribed opioids or prescribed fentanyl. However, some of the faces represent people who eventually overdosed on heroin. All of these addictions, however, began with prescribed medications.”

For starters, the notion that all addictions begin with prescriptions is -- to put it kindly -- misinformed. Toxicology tests also cannot differentiate between prescription fentanyl and illicit fentanyl, although the latter is now believed to be responsible for more overdoses than any other drug. And why would the faces of people who overdosed on heroin be included in a memorial to victims who died from prescription opioids?

The National Safety Council is a nonprofit that promotes itself as a "data-driven organization" focused on preventing unnecessary injuries and deaths. It was established by labor unions in 1913 to improve workplace safety but is now funded largely by corporations, including the insurance industry.

For several years the NSC has had an aggressive marketing campaign against the use of opioid medication.

"Opioids do not kill pain. They kill people," says NSC medical advisor Donald Teater, MD, on the organization’s website.

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The NSC recently released a 32-page report called “Prescription Nation 2018” that calls prescription opioids “a gateway drug to heroin” that were "liberally prescribed, setting the stage for a flood of people suffering from opioid use disorder, overdose and death.”

An NSC analysis found that just 13 states and Washington DC have implemented adequate policies to prevent opioid overdoses, such as adopting prescribing guidelines and mandating prescriber education. The report says 29 states are lagging in adopting such policies and 8 of them are failing. 

The organization did not respond to a request for an interview. 

Fewer Opioids Prescribed in Medical Marijuana States

By Pat Anson, Editor

The availability of medical marijuana has significantly reduced opioid prescribing for Medicaid and Medicare patients, according to two large studies published in the Journal of the American Medical Association (JAMA).

In one study, researchers at the University of Georgia looked at Medicare Part D prescription drug data from 2010 to 2015. They found that the number of daily doses prescribed for morphine (-14%), hydrocodone (-10.5%) and fentanyl (-8.5%) declined in states with medical marijuana laws. However, daily doses for oxycodone increased (+4.4%) in those same states.

The drop in opioid prescribing was most pronounced in states that have medical marijuana dispensaries, as opposed to those that only allow home cultivation of cannabis for medical purposes.

“We found that prescriptions for hydrocodone and morphine had statistically significant negative associations with medical cannabis access via dispensaries,” wrote lead author W. David Bradford, PhD, Department of Public Administration and Policy at the University of Georgia.

“Combined with previously published studies suggesting cannabis laws are associated with lower opioid mortality, these findings further strengthen arguments in favor of considering medical applications of cannabis as one tool in the policy arsenal that can be used to diminish the harm of prescription opioids.”

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The second study, by researchers at the University of Kentucky, looked at Medicaid prescriptions from 2011 to 2016, and found a 5.88% decline in opioid prescribing in states with medical marijuana laws.  Opioid prescribing for Medicaid patients fell even more -- by 6.38% -- in states where the recreational use of marijuana is legal.

“These findings suggest that medical and adult-use marijuana laws have the potential to reduce opioid prescribing for Medicaid enrollees, a segment of population with disproportionately high risk for chronic pain, opioid use disorder, and opioid overdose,” wrote lead author Hefei Wen, PhD, University of Kentucky College of Public Health.

One weakness of both studies is that they did not determine if Medicaid and Medicare patients reduced their use of opioid medication because they were using cannabis.  They also only included patients that were elderly, poor or disabled. And they were conducted during a period when nationwide opioid prescribing was in decline.

A recent study by the RAND corporation found little evidence that states with medical marijuana laws experience reductions in the volume of legally prescribed opioid medication. RAND researchers believe some pain patients may be experimenting with marijuana, but their numbers are not large enough to have a significant impact on prescribing. 

"If anything, states that adopt medical marijuana laws... experience a relative increase in the legal distribution of prescription opioids," the RAND study found. "Either the patients are continuing to use their opioid pain medications in addition to marijuana, or this patient group represents a small share of the overall medical opioid using population." 

Although 29 states and the District of Columbia have legalized medical marijuana and a handful of states allow its recreational use, marijuana remains illegal under federal law.