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.  

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.

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.  

FDA Staff Recommends Approval of Marijuana Drug

By Pat Anson, Editor

The U.S. Food and Drug Administration may be on the verge of approving its first prescription drug derived directly from marijuana.

In a report posted online, FDA staff said there was “substantial evidence” that Epidiolex, a liquid formula containing cannabidiol (CBD), was effective in reducing seizures in children with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), two severe forms of childhood epilepsy.

GW PHARMACEUTICALS IMAGE

Epidiolex is made by GW Pharmaceuticals, a British drug maker that specializes in developing drugs from marijuana.

“The applicant has provided positive results from three randomized, double-blind, placebo-controlled studies conducted in patients with LGS and DS,” FDA staff reported.

“The studies are adequate and well-controlled. The statistically significant and clinically meaningful results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS.”  

CBD is one of the active ingredients in marijuana. It does not contain THC (tetrahydrocannabinol), the chemical compound in marijuana that makes people high. Many oils and tinctures containing CBD are already sold online and in states were medical marijuana is legal, but the FDA has not approved any of them.  The agency has only approved a handful of synthetic cannabinoids such as Marinol (dronabinol) to treat loss of appetite and nausea.

Although some children in the clinical trials experienced side effects from Epidiolex such as liver toxicity, anemia and drowsiness, the FDA staff report said the risks were “mild to moderate” and could be managed with warning labels. The report also found there was low risk of the strawberry flavored Epidiolex being abused.

“Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with LGS and DS,” the report concludes.

(4/18/18 Update: An FDA advisory committee unanimously recommended that the FDA accept the staff findings and approve Epidiolex) 

In a briefing paper for the committee, GW Pharmaceuticals said there were few effective treatment options for children with LGS and DS, who often have severe intellectual and developmental disabilities and a high risk of mortality.

A final decision by the FDA is expected this summer. There is no guarantee the agency will follow the advice of its staff or advisory committee. If Epidiolex is approved, it would only be for the treatment of childhood epilepsy. However, doctors would presumably be able to prescribe it “off label” for other conditions such as chronic pain.  

GW Pharmaceuticals also makes Sativex, an oral spray that contains both CBD and THC. Sativex has been approved in Europe, Canada, Australia, New Zealand and several other countries for the treatment of muscle spasticity caused by multiple sclerosis. In Israel, Sativex is also approved for the treatment of pain and chronic non-cancer pain.  

Lessons from ‘Dark Paradise’ on the Opioid Crisis

By Roger Chriss, Columnist

The book “Dark Paradise: A History of Opiate Addiction in America” by David Courtwright lives up to its title. Starting as far back as the Revolutionary War, Courtwright gives substance and statistics about opioids in the United States. The book clearly shows that America has had one ongoing opioid crisis for its entire history.

Courtwright starts with the premise that “Over and over again the epidemiological data affirms a simple truth: those groups who, for whatever reason, have had the greatest exposure to opiates have had the highest rates of opiate addiction.”

He also takes pains to show how the demographics of addiction shifted over time, moving from men to women and back to men, from the upper class to the working class to immigrants and back again. Seemingly new twists and turns in the present opioid crisis are actually just variations on an old theme.

Addiction rates and trends from 100 years ago seem all too familiar. Courtwright tells us there were about 313,000 opium and morphine addicts in America prior to 1914, with many of them concentrated in the South. But who became addicted was different.

“The outstanding feature of nineteenth-century opium and morphine addiction is that the majority of addicts were women,” wrote Courtwright. “It was principally in those suffering from chronic ailments that use of these drugs led to addiction.”

At the time, opioids were used to treat everything from ennui and anxiety to social performance and sleep -- disorders that nowadays would be treated with other medications. The causes cited are also familiar. “In addition to laziness and incompetence (by physicians), greed was cited as a reason for continued abuse” and 19th century pharmacists “were notorious for their willingness to supply a user; opium and morphine were their bread and butter, and there is no steadier customer than an addict.”

The underground trade in opioids was already a major problem at the turn of the 20th century: “The ingenuity of the opiate smugglers knew no bounds. One supercargo reportedly packed $500 worth of opium into the false bottom of a snake cage.”

As they have today, lawmakers and policymakers responded vigorously, but often with hidden agendas and dubious statistics. In the 1910s, physician and scientist Hamilton Wright used scare tactics to push for legislation on domestic narcotic trafficking. Andrew DuMez of the Treasury Department used “grossly inaccurate” figures about addicts. And Congressman Henry Rainey tried to convince the American public “that addiction was a problem of massive dimensions.”

By the early 20th century, “Opium and morphine had fallen into such disfavor that some physicians began to worry that they might be withheld in even the most dire cases.” Then as now, lawmakers were often behind the curve on the crisis and used fear to advance personal agendas.

This raised concerns that are echoed today about opioid medications. “The present generation (of doctors) has been so thoroughly warned, both by teaching at college and by observation,” wrote New Hampshire physician Oscar Young in 1902, “that now they are in many instances so very afraid to give it, even for the worst pain, that the patient suffers agonies worse than any hell for want of one-eighth of a grain of morphine.”

The opioid pendulum had shifted so much by 1920 that the American Medical Association warned that opiates should not be denied to patients suffering from conditions “such as cancer, and other painful and distressing diseases.”

Although this new conservatism greatly reduced rates of iatrogenic addiction caused by medical treatment, opioids continued to be a problem, especially as heroin spread from New York City to the rest of the nation. Courtwright notes that “heroin addicts typically became addicted in adolescence or early adulthood” and that their addictions were rarely iatrogenic in nature.

Heroin succeeded in a way that no other illicit drug had before: “Heroin was the illicit drug par excellence. It spread throughout the country during the 1920's and 1930's because dealers and their customers came to appreciate its black-market virtues.”

World War II interrupted virtually all aspects of life in the United States, including opioid abuse and addiction. But developments in pharmaceutical research contributed to changes as well. “Indeed, one of the reasons why medical morphine addiction largely vanished during the twentieth century was that physicians had so many alternatives for inducing sleep, soothing nerves, and brightening mood.”

Interestingly, in the 1950s, “No one, least of all federal agents, regarded the use of opiates to alleviate intense, pathological suffering as inappropriate or illegal.”

But then heroin surged in popularity in the 1960’s. Courtwright carefully assembles statistics on addiction rates. There were an estimated 120,000 heroin addicts in the 1950’s. The number rose to 315,000 in late 1969 and by the end of 1971 there were 560,000 heroin addicts. That number has remained relatively stable. Today the National Institute on Drug Abuse estimates that there are 591,000 heroin addicts in the United States.

But there was little data on overdose fatalities until the 1970’s. Courtwright reports that heroin-related deaths rose from 1,980 in 1990 to 3,980 in 1996, double the peak death rate in the 1970’s. A key factor in the increasing fatality rate was the combined use of heroin with other drugs.

With the development of methadone maintenance in the 1960's, a new approach to heroin and other forms of opioid addiction arose. “Enforcement must be coupled with a national approach to the reclamation of the drug user himself,” said President Richard Nixon in 1971. But despite its documented effectiveness, Courtwright notes that methadone “never emerged as a coherent national response to heroin addiction.”

The history of opioids in “Dark Paradise” ends at the start of the 21st century. The book does not mention the rise of OxyContin, the movement to treat pain as a vital sign, or the recent spikes in opioid-related overdoses. Nor does it discuss the appearance of Mexican black tar heroin, illicitly manufactured fentanyl or darknet drug markets.

But it does tangentially address what works and what doesn’t. The “War on Drugs” has failed repeatedly, as have policies to criminalize addiction or institutionalize addicts. The three approaches that would probably do the most to help end the opioid crisis -- securing the medical opioid supply against theft and diversion, disrupting the illegal supply by attacking distribution networks, and providing treatment to the addicted -- have never really been tried with any consistency.

Courtwright notes at the opening of “Dark Paradise” that “what we think about addiction very much depends on who is addicted.” But he also shows that we prefer to do very little beyond what is ideologically appealing or politically expedient. Instead, we keep trying the same things over and over and then act surprised when we get the same results. This is more commonly known as the definition of insanity than of paradise, dark or otherwise.

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.

Dear AARP: Stop Picking on Pain Patients

(Editor’s Note: Last year PNN columnist Rochelle Odell wrote an article critical of the American Association of Retired Persons (AARP) for publishing a special report entitled “The Opioid Menace.” The report claimed that many older Americans had become “new opioid dealers” who were fueling the opioid crisis by “selling their prescription painkillers to drug pushers.”

AARP recently published a new bulletin, which focuses on how scammers are bilking Medicare for $60 billion annually. Once again, AARP claims that Medicare fraud "puts deadly pills on the street" and helps fuel the opioid crisis. In response, Rochelle wrote this open letter to AARP’s editors.)

Dear AARP Editors,

I received the AARP Bulletin and at first found your cover story on Medicare fraud interesting. Fraud is a major problem that will need patients, physicians and law enforcement to resolve. It causes healthcare costs to rise, which many of us on Social Security and fixed incomes can’t afford to pay.

As I got towards the end of the bulletin, my anger began to rise as I read "The Opioid-Medicare Connection." You claim that “shady doctors are writing bogus prescriptions for opioid painkillers” using stolen Medicare ID numbers and that “the pills are then sold on the street for huge profits.”

“The practice is shockingly common, and the impact is severe. For Medicare, it means covering the cost of countless millions of high-priced pills that never should have been prescribed. At the same time, prescription opioids are responsible for an estimated 95 overdose deaths a day in the United States,” the article claims, without ever citing a source for that information. 

It brought me back to last summer when AARP published "The Opioid Menace." Why is AARP constantly attacking opioid pain medication? Why do you continually write misleading information about opioids? Could it be dollar motivated? 

Then I read about AARP's survey on medical marijuana, which found that a majority of older Americans “think marijuana is effective for pain relief and should be available to patients with a doctor’s recommendation.”  I have to disagree with the survey findings. There are many of us who have tried medical cannabis and received zero benefit. It did nothing for my pain. 

Then it dawned on me, of course insurance providers such as AARP would like more patients to use cannabis. As it becomes harder for us to get prescription opioids, many pain patients are turning to cannabis, a treatment that AARP and other insurers don't have to pay for. How much will that fatten your bottom line?

I find it hard to believe stolen Medicare ID numbers play that big of a role in the opioid crisis. Prescriptions for opioid medication are tracked more than ever, with doctors, pharmacists and insurers having instant access to databases to see just how many prescriptions a patient is getting.

I have been on Medicare since 1997 due to becoming disabled by Complex Regional Pain Syndrome (CRPS). There has never been a time that I did not have to present a picture ID when picking up an opioid prescription. And if I was unable to pick them up myself, a friend or relative had to present my ID confirming it was indeed for me, along with my current address.

Please explain how the "shady doctors" you referred to in your article are able to pull off this "shockingly common" fraud and make “huge profits.” As in last year's Opioid Menace article, AARP uses minimal references to support these claims. It was interesting you referenced only one physician who did this, only one. 

Medicare just published a new rule starting in 2019, which impose new limits on high dose opioids and requires “high risk” patients to see a specific physician and use a specific pharmacy. Think of the money you can save now. More patients paying out of pocket for medical cannabis and prescription opioids being reduced or stopped. 

Whatever happened to AARP being there for us older Americans?

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

Prominent Pain Doctor Faces Hundreds of Lawsuits

By Pat Anson, Editor

Imagine spending your retirement defending yourself against hundreds of lawsuits in courthouses around the country – all of them alleging that you played a key role in starting the opioid crisis and that you were indirectly responsible for thousands of overdose deaths.

“It is mind boggling to me and its frightening, actually. I don’t know how I’m going to defend myself,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “Right now, we’re just trying to keep our head above the water.”

Webster has been named as a defendent in so many class action lawsuits – along with Purdue Pharma, Johnson & Johnson, Endo, Janssen and other opioid manufacturers – that he’s lost track. He knows of at least 80 lawsuits but believes there are many more.

“I think it could be several hundred,” he says.

The latest one was filed this week by Salt Lake County, Utah -- where Webster lives -- alleging that drug makers employed him in deceptive marketing practices that downplayed the risks of addiction and overdose. Like the other lawsuits by states, counties and cities, Salt Lake County seeks to recover taxpayer money spent on treating addiction, combating opioid abuse and policing opioid related crimes.    

DR. LYNN WEBSTER

“Utah’s opioid crisis stems directly from a callously deceptive marketing scheme that was spearheaded by certain opioid manufacturers and perpetuated by prominent doctors they bankrolled,” the lawsuit alleges.

“Dr. Webster’s advocacy of opioids was designed to create a veneer of impartiality. But Dr. Webster was a forceful proponent of the concept of ‘pseudoaddiction,’ the notion that addictive behaviors should be seen not as a warning, but as indicators of undertreated pain. The only way to differentiate between the two, Dr. Webster claims, was to increase a patient’s dose of opioids.”

Until he retired from clinical practice in 2010, Webster operated the Lifetree Pain Clinic in Salt Lake City. The lawsuit makes a point of mentioning that at least 20 of Webster’s patients died from overdoses and that he was investigated – but never charged with a crime -- by the DEA and the U.S. Senate Finance Committee.

“Most of what they have in there, at least about me, is false. And I think I can prove that,” Webster told PNN.

A footnote in the lawsuit contains the curious but important disclaimer that “Salt Lake County asserts no claim against Dr. Webster arising from his medical practice. The claims against Dr. Webster relate solely to his participation, as a KOL and otherwise, in Manufacturing Defendants deceptive marketing campaign.”

'Key Opinion Leader'

KOL is an acronym for “key opinion leader” – a euphemism for doctors alleged to be so influential that they helped convince other physicians to prescribe more opioids. Webster and three other pain doctors -- Russell Portenoy, Perry Fine and Scott Fishman -- are portrayed in the lawsuits as KOLs who greedily accepted millions of dollars in payments from drug makers in return for their promotion of opioids.

“It's mind boggling to think how four individuals can be accountable for essentially brainwashing all of the doctors in the country to do something intentionally to make pharmaceutical countries rich. How can anyone think that is plausible? It’s crazy,” says Webster. “Most of the pharmaceutical companies that they’ve listed I never received a dime from.”

According to the Salt Lake County lawsuit, Webster was “handsomely rewarded for his efforts,” receiving nearly $2 million from opioid manufacturers from 2009 to 2013. Webster says that dollar amount is unfair and misleading because most of it stems from his work as a researcher. He is currently Vice President of Scientific Affairs at PRA Health Sciences, a clinical research company.

“If you’re a principal investigator in a research program that has contracted with a pharmaceutical company, that money goes under your name. But its money to conduct a trial. Not a penny of it goes to me,” says Webster. “I have received compensation for consultant work and advisory boards. My consultant work is because of my area of expertise. That’s not unusual. And I do not speak for a company’s product. I do not benefit at all because I personally have no shares in any pharmaceutical company.”

Since retiring from clinical practice, Webster has become an outspoken critic of efforts by the government and insurance industry to limit opioid prescribing -- which he believes have gone too far and unfairly punish pain patients, while ignoring the larger issue of illicit fentanyl, heroin and other black market drugs.

He's written a book, called "The Painful Truth" and self-financed a PBS documentary by the same name.  Webster also comments frequently on PNN about opioid related issues.

With so many lawsuits hanging over him, Webster’s financial future is uncertain.  He says he and his fellow KOLs could be bankrupted by legal fees before any of the lawsuits come to trial.

“We don’t have any big pocket that’s going to pay for anything,” he said. “If a jury decided to award money from us, they wouldn’t get any money, because there is no money. We would be all bankrupt by the time we got to court.”

Drug makers, on the other hand, do have big pockets. And during the 1990’s many of the same law firms now involved in opioid litigation helped win big settlements with the tobacco industry worth upwards of $200 billion.  That includes the law firm of Hagens Berman, which is handling the Salt Lake County lawsuit. The firm also represents the city of Seattle in a nearly identical lawsuit against opioid makers, in which Webster is named as a KOL.

Webster is also named in a string of lawsuits filed by the law firm of Simmons Hanly Conroy, which represents dozens of states, counties and cities. Simmons will pocket one-third of the proceeds from any opioid settlement,  which could run into hundreds of billions of dollars.

Simmons is well connected politically, having donated $219,000 to the re-election campaign of Missouri Sen. Claire McCaskill (D), who coincidentally released a report in February that's highly critical of patient advocacy groups and medical associations for accepting money from opioid manufacturers.

It is against these political, financial and legal forces that Webster must find a way to defend himself.

“The body of the allegations are inaccurate, misleading and irresponsibly paint a picture which ignores the realities of Dr. Webster’s compassionate commitment to alleviating suffering in his chronic pain patients,” Peter Striba, Webster’s attorney, wrote in a letter to the Salt Lake Tribune. “It is estimated that there are approximately one-hundred million chronic pain patients in our Country, and it is very telling that their suffering and their medical condition is entirely absent in the narrative of the Complaint.” 

Should You Record Your Medical Appointments?

By Barby Ingle, Columnist

My memory troubles started soon after developing Reflex Sympathetic Dystrophy in 2002. “Brain fog” or “pain brain” is a common symptom of RSD, fibromyalgia and other chronic pain conditions. Our brains have trouble focusing on short term memories and storing them for easy recall.

Even now, in a semi-state of remission, I have trouble saying the right words at the right time or remembering if I have seen a movie before. To help my memory and keep appointments, I started keeping a “to do” list and using a color-coded calendar and a medication dispensing system. I also made a habit of recording phone calls and conversations with my healthcare providers.

I’m not alone. According to a recent JAMA article, about 15% of patients in the UK secretly record their medical visits, often using their smartphones. I have been recording since 2003, after I realized that my memory was weak and that I needed assistance to better comply with my care between appointments.

How many times have you hung up the phone and your spouse asked, “Who was that? What did they need?” Or they came home from work and asked, “What did the doctor say?” or “What did you do today?”

And you can’t answer.

Before you think, “Oh, Barby must have been high on her pain medication,” that for me is a big fat NOPE. It happened to me when I was not on any medications. It is a symptom of my medical condition, not a symptom of the medications I take. For some patients on other medications that may be a problem, but it only adds to the already challenged mind of someone with chronic pain or traumatic brain injuries. The worse the pain gets, the worse their memory gets.

While you're talking, you think, “Oh, this is important, I will remember this.” Yet, you don’t. You can’t recall what you had for breakfast or when you last took your medication, let alone the intricacies of a doctor appointment.

Studies show that recording medical appointments reduces malpractice claims and leads to better understanding from patients on what their care is and why. This leads to better patient compliance and engagement in their own health outcomes.

The University of Texas Medical Branch is promoting patient recording of their visits. They tell patients it is an open policy that is there to protect them and their providers. Check out the video they created: 

Is It Legal?

I live in a state where recording a conversation only has to be known by one party. But if you are in New York or California, you have to inform and get permission from all those who may be recorded in advance.

Sometimes I record in secrecy, but most times I have my husband or sister record the appointment -- and it is quite clear what they are doing. In 15 years of doing this, I have only had one doctor ever ask me to erase the recording. That was because he had other providers in the room examining me and he talked about proprietary information that didn’t have to do with my medical condition.

I know that when I am under stress or have high pain levels, I need to record or have someone take notes at the appointment or both. It’s hard to remember if you’re supposed to take a new medication twice a day before meals, on an empty stomach, or once in the morning and once at night. Appointment times are also getting shorter and more filled with new medical terms and information that is important for us to remember.

In general, a healthy person only remembers about 25% of a conversation as soon as it is over. If you have a stressful chronic condition, even remembering that much is almost impossible. So why not record for your own safety? With most smartphones, all you have to do is press record at the start of the appointment and then hit stop at the end.

You’ll be better engaged, have an accurate account of the appointment, and be able to refer back to it when you get home and someone asks, "What did the doctor say?"

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy 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.

Medical Marijuana’s Catch-22: Policy Before Science

By Marisa Taylor and Melissa Bailey, Kaiser Health News

By the time Ann Marie Owen turned to marijuana to treat her pain, she was struggling to walk and talk. She also hallucinated.

For four years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness and paralysis.

The drugs not only failed to ease her symptoms, they hooked her.

When her home state of New York legalized marijuana for the treatment of select medical ailments, Owens decided it was time to swap pills for pot. But her doctors refused to help.

“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”

While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws — a predicament that is only worsened by thin scientific data.

ANN MARIE OWEN (ALLYSE PULLIAM FOR KHN)

Because the federal government classifies marijuana a Schedule 1 drug — by definition a substance with no currently accepted medical use and a high potential for abuse — research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.

Underscoring the federal government’s position, Health and Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”

Scientists say that stance prevents them from conducting the high-quality research required for FDA approval, even as some early research indicates marijuana might be a promising alterative to opioids or other medicines.

Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.

“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Dr. Orrin Devinsky, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’”

The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.

Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the University of Mississippi is inadequate for high-quality studies.

The marijuana, which comes in a micronized powder form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles that are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.

Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.

“It’s public policy before science,” said Dr. Chinazo Cunningham, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”

Cunningham, who received a five-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.

“It’s a catch-22,” said Cunningham, who is with the Albert Einstein College of Medicine. “We’re going to be looking at all of these issues — age, disease, level of pain — but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’

Don’t Ask, Don’t Tell

Without clear answers, hospitals, doctors and patients are left to their own devices, which can result in poor treatment and needless suffering.

Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.

Some have a “don’t ask, don’t tell” approach, said Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.

Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Devinsky, the director of NYU Langone’s Comprehensive Epilepsy Center.

“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”

The Trump administration, however, has resisted policy changes.

Last year, the Drug Enforcement Administration had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.

The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.

The DEA and HHS have cited concerns about medical supervision, addiction and a lack of “well-controlled studies proving efficacy.”

Patients, meanwhile, forge ahead.

While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans 65 and older who say they are using the drug skyrocketed 250 percent from 2006 to 2013.

Some patients turn to friends, patient advocacy groups or online support groups for information.

Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.

“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk and talk again.”

Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.

“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”

Still, doctors and scientists worry about the implications of such experimentation.

In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”

The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review, including finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.

‘I Broke Federal Law’

Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.

Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.

“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”

Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.

The conflict in the law makes her uneasy. But Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”

Others experience mixed results.

Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.

 “She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.

Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”

The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.

The researchers running the trial at Connecticut Hospice spent two years getting necessary approvals from the Food and Drug Administration, the National Institute on Drug Abuse (NIDA) and the DEA.

Started in May, the trial has enrolled only seven of the 66 patients it plans to sign up because many patients were too sick, too close to death or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.

Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.

“We just have no data on how many older adults are using medical marijuana, what they are using it for and most importantly what are the outcomes,” said Brian Kaskie, a professor at the University of Iowa’s College of Public Health. “It’s all anecdotal.”

Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based Retirement Research Foundation to survey the use of medical marijuana by older Americans.

In many quarters, there’s a growing appetite for solid information, he said.

“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”

drug policy alliance

Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.

In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of marijuana and other drugs on older adults and pain.

NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.

Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente. KHN’s coverage of end-of-life and serious illness issues is supported in part by the Gordon and Betty Moore Foundation.

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

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.

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. 

DEA Takes Steps to Reduce Hospital Opioid Shortages

By Pat Anson, Editor

In response to a growing number of complaints about shortages of opioid pain medication in U.S. hospitals, the Drug Enforcement Administration is allowing some drug makers to increase their production of injectable opioids.

The shortages were first reported last summer but have intensified in recent months – leaving some hospitals scrambling to find morphine, fentanyl and other injectable opioids to treat patients suffering from acute pain after surgery or trauma. The shortages are largely due to manufacturing problems at Pfizer, which controls 60 percent of the market for injectable opioids.

“DEA is working closely with the U.S. Food and Drug Administration, drug manufacturers, wholesale distributors and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. These include certain injectable products that contain morphine, hydromorphone, meperidine, and fentanyl,” the agency said in a statement.

The DEA said it gave permission to three other drugs makers to produce the injectable drugs after Pfizer “voluntarily surrendered” part of its quota allotment.

“It is important to note that an increase in DEA procurement quotas to various manufacturers cannot alone prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products,” the agency said.

But critics say the DEA itself is partly responsible for the shortages. The agency may not control how companies manufacture drugs – but it has a big say on the amount. Under federal law, the DEA sets annual production quotas for each drug maker to produce opioids and other controlled substances.

Because of growing concerns about the overdose crisis, the DEA ordered a 25 percent reduction in opioid manufacturing in 2017 and an additional 20 percent cut in 2018. This year’s cuts were ordered despite warnings from three drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

A group of 16 U.S. Senators – led by Illinois Democrat Dick Durbin – urged the DEA to make the production cuts. 

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the senators wrote in a September 2017 letter to then acting DEA administrator Chuck Rosenberg.

According to Kaiser Health News, shortages of injectable opioids have led to an increasing number of medical errors and left trauma patients suffering in pain. Some hospitals are rationing opioids like Dilaudid, and using nerve blocks, acetaminophen and muscle relaxants instead.

The DEA said it would make further adjustments to opioid quotas if they are needed and would “also consider other measures that may be necessary.”

More Americans Worried About Rx Drug Misuse

By Pat Anson, Editor

A recent study by the Centers for Disease Control and Prevention found that about one in four overdose deaths in 2016 involved prescription opioids. That’s a lot – but it’s far less than the number of Americans killed by illegal drugs such as heroin, cocaine and illicit fentanyl – which account for nearly two-thirds of all drug related deaths.

But a new survey shows that a growing number of Americans still blame the overdose crisis on prescription drugs.

The nationwide poll by the Associated Press and the NORC Center for Public Affairs at the University of Chicago found that 43 percent of Americans believe the misuse of prescription drugs is a serious problem in their community. That’s up from 33% two years ago. Only 37 percent see heroin as a serious concern locally.

The survey findings show that many Americans have a conflicted attitude about the opioid crisis and drug misuse in general.

For example, while over half (53%) believe prescription drug addiction is a disease that is treatable, a significant number (39%) think substance abuse is caused by mental illness. Forty-three percent think opioid addiction shows a lack of willpower or discipline, and nearly a third (32%) say it’s a character defect or a sign of bad parenting.

The stigma associated with drug addiction is strong. Fewer than 1 in 5 Americans are willing to associate closely with a friend, colleague or neighbor who is addicted to prescription drugs.  

"In the national effort to grapple with the enormous issue of opioid addiction, it is important to know the level of awareness and understanding of Americans who find themselves in the midst of an epidemic that is claiming growing numbers of lives," said Caitlin Oppenheimer, senior vice president of public health at NORC. "This survey provides important, and in some cases troubling, information."

Other survey findings:

• 13% of Americans had a relative or close friend die from an opioid overdose.
• 24% have an addicted relative, close friend, or say they themselves are addicted to opioids.
• Two-thirds say their community is not doing enough to make treatment programs accessible and affordable
• 64% would like to see more effort to crack down on drug dealers.

"The number of people who recognize how serious the opioid epidemic is in this nation is growing," said Trevor Tompson, vice president for public affairs research at NORC. "There is clearly a continuing challenge to ensure that what is learned about the crisis is grounded in fact."

The survey found that Facebook plays a dominant role in how Americans get their news – particularly about opioids. Of the 74 percent of adults who use Facebook, 41 percent say they have seen messages about opioids or deaths from overdoses. Fewer users of Twitter, Instagram and other social media platforms report seeing such information.

The nationwide survey of 1,054 adults was conducted online and using landlines and cell phones. The margin of sampling error is +/- 4.1 percentage points.

How CDC's Opioid Guidelines Killed My Mother

Sheila Ramsey, Guest Columnist

For the past year, I have been reading the heartbreaking stories being posted about the degrading and inhumane treatment of the elderly, critically ill and disabled persons by our government, healthcare institutions and physicians.

And all I can do is sit here and cry, thinking about the struggles that my mother went through for the last 25 years of her life. She was a diabetic for 40 years, had rheumatoid arthritis, osteoarthritis, degenerative disc disease, high blood pressure, depression and cystic lung fibrosis. These conditions caused her much pain every day.

She was placed on a low dose of hydrocodone 20 years ago. It did not completely erase her pain, but made it manageable to where she wasn’t completely bedridden.

Then in 2016, when the CDC came out with their opioid "guidelines," her doctor reduced her dosage three times. I watched her suffer immensely and she pleaded with him to raise it several times. He would not.

Her life became more miserable than before and her depression worsened. She even had to stop driving, relying on me and a few friends to take her to appointments and grocery shopping once a week. Which were the only times she got out of her small one-bedroom apartment.

In May 2017, her lung disease got worse and it was hard for her to breath due to panic attacks several times a day. Her pulmonary doctor placed her on a low dose of Ativan to reduce her anxiety.

JANET DIXON

As soon as her primary care doctor found out about that, he immediately gave her a choice of which illness she was willing to suffer from: panic attacks or chronic pain due to her many incurable illnesses. She chose the Ativan and he immediately stopped her pain meds. She then had to start using a walker instead of her cane.

In June 2017, she had a friend drop her off to see her lung doctor. While waiting for the elevator, she tripped over her walker, fell and broke her hip. She went into the hospital for surgery, caught pneumonia and had to be placed in a medically induced coma. She also had congestive heart and kidney failure. She was waiting on a lung transplant but did not make it. We had to take her off life support on October 25, 2017.

This was all due to complications from being in the hospital for a hip surgery that never would have been needed if she did not have to use a walker and had not been taken off pain medication! If her pain had been controlled, my mother might still be alive.

That’s why it angers me that our government is denying medication to patients that benefit from them. How in America can our lawmakers let this happen? I’ve written so many letters. I don’t know who else to contact or what else I can do to help all the people who have been brutally denied pain relief and subjected to humiliating and degrading treatment. Please if there is anything I can do to help stop this neglect, I’m all in.

I just want to let everyone who reads this to know that I feel for each and every one of you who is suffering, and I hope this ends soon. God bless you all.

Sheila Ramsey lives in Ohio. Her mother, Janet Dixon, died last year at the age of 69.

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.

Rallies Draw Attention to Suffering of Pain Patients

By Pat Anson, Editor

Hundreds of people braved the rain, wind and cold Saturday to take part in a nationwide series of rallies in support of people living with chronic pain and illness.

The “Don’t Punish Pain” rallies were organized by a grassroots group on Facebook and held mostly at state capitols in 47 states.

The primary goal of the rallies is to get the Centers for Disease Control and Prevention to change its opioid prescribing guidelines, which have caused many doctors to stop treating patients with opioid medication or to drastically lower their doses.

Although attendance was sparse in some locations, a dozen or more people gathered in Baton Rouge, Dallas, Little Rock, Annapolis and several other cities.

Some protestors brought an empty pair of shoes to represent people who were too ill to attend, those who have died due to poorly treated pain, and some who have committed suicide.

While the turnout may have been disappointing to some, the rallies were successful in attracting local media attention – shining a rare spotlight on the plight of pain patients and how many are suffering in an age of hysteria over opioid medication and the overdose crisis.

"We have gone so much to the other side that we are forgetting that there are voices of pain that need to be heard," Carlene Hansen told KIVI-TV in Boise, Idaho. "I've been on medications for 5-7 years and always take it as prescribed."

 "I think that a responsible doctor is going to do the right thing and prescribe the right medications for the right individual," Michele Thomas told the News Tribune in Jefferson City, Missouri. "Where I have a problem is when the government comes in and tells the doctor that they cannot prescribe what the doctor feels is the best medication."

“Doctors need to be able to treat their patients again,” Karlyn Beavers told WLNS-TV in Lansing, Michigan. "I have pain every day. Whether some days it may be light, some days it's heavy, but it's always there.”

The Don’t Punish Pain rallies were organized in the last few months on social media without support or funding from patient advocacy groups or pharmaceutical companies.

Since the CDC released its opioid guidelines in 2016, many patients say the quality of their medical care has gone downhill. 

In a PNN survey of over 3,100 patients on the first anniversary of the guidelines, 84 percent said their pain and quality of life had gotten worse. Over 40 percent said they had considered suicide and 11 percent said they had obtained opioids on the black market for pain relief.

CDC researchers recently admitted that they significantly overestimated the number of Americans that have died from overdoses involving opioid medication. A CDC report released last month found that most drug deaths are actually caused by illicit fentanyl, heroin, cocaine and other drugs obtained on the black market.

More Salmonella Cases Linked to Kratom

By Pat Anson, Editor

The Centers for Disease Control and Prevention says another 45 people have been sickened in a salmonella outbreak linked to the herbal supplement kratom.  A total of 132 people have been infected in 38 states, with 38 of them hospitalized. There have been no deaths.

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States.

This particular outbreak is small compared to previous ones, but it’s been long-lasting. While the vast majority of cases have only been reported in the last few months, CDC traced the first illnesses back to January 2017. Three different Salmonella strains have been identified – none of them resistant to antibiotics.

Millions of Americans use kratom to treat chronic pain, addiction, depression, anxiety and other medical conditions. The CDC says kratom is the “likely source” of the outbreak – although the evidence behind it is not entirely clear.

Several kratom samples have been found to be contaminated with salmonella bacteria, but less than half the people sickened in the outbreak say they consumed kratom. Their ages are also unusual, ranging from 1 to 73 years old.

salmonella bacteria

“State and local health officials continue to interview ill people to ask about the foods they ate and other exposures before they became ill. Fifty-seven (73%) of 78 people interviewed reported consuming kratom in pills, powder, or tea,” the CDC said in its latest update.

“People who reported consuming kratom purchased it from retail locations in several states and from various online retailers. Despite the information collected to date about where ill people purchased kratom, a single common brand or supplier of kratom has not been linked to the outbreak. CDC continues to recommend that people not consume kratom in any form because it could be contaminated with Salmonella and could make people sick.”

Earlier this week, the Food and Drug Administration ordered a Las Vegas company – Triangle Pharmanaturals -- to recall all of its dietary supplements containing kratom. The rare mandatory recall order was issued after the company refused to make a voluntary recall when some of its kratom capsules were found contaminated with salmonella.

There other kratom distributors – PDX Aromatics, Tamarack and NutriZone voluntarily recalled their products after samples tested positive for salmonella. A complete list of recalled kratom products can be found here.

Many kratom supporters remain suspicious of the motives behind the federal government’s salmonella investigation. The Drug Enforcement Administration tried unsuccessfully to list kratom as a controlled substance in 2016, which would have effectively banned its sale and use. In recent months, the FDA has also released several warnings that kratom should not be used to treat any medical conditions because it has opioid-like properties and could cause addiction.

The American Kratom Association (AKA) – a pro-kratom association of consumers and vendors -- is currently surveying members “to get a clearer picture” of the actions taken by the FDA and CDC in the salmonella outbreak.

“We are particularly concerned with reports that the FDA/CDC may be using the salmonella outbreak purportedly in kratom products as a pretext to allow the FDA to expand their war on kratom,” the AKA says on its website. “If your business was contacted by either the FDA or CDC regarding the salmonella outbreak that has been associated with kratom, we are asking that you take the following survey.”

Among other things, the survey asks vendors if they were given a laboratory analysis of any “alleged salmonella contamination” by the FDA or CDC, and if they were given time to conduct their own independent lab test.    

A Pained Life: My Medical Marijuana Experiment

By Carol Levy, Columnist

I just got my medical marijuana ID card.

I never tried marijuana as a teen. The one time someone gave me a sample of their medical marijuana, it made me feel terrible, as though I had taken a large dose of opioid medication -- fuzzy mouthed and cloudy brained.

It made me leery, but once it became legal in Pennsylvania there was no way I would not try it.

First thing you have to do is find a state certified doctor. There are only a few, so you are pretty much stuck with whomever is nearby. Before I could see the doctor, I had to give a urine sample. I have never been asked before to do this. All patients are required to – so they can weed out those who may be abusers.

That does not make it any less uncomfortable. I felt, as many do, as though I had been convicted of something and now had to prove my innocence.

The expense seems to be created to make it very hard to access. I am on a fixed disability income. The first visit with the doctor cost $125. This fee was required at the time of the appointment. The doctor told me that I would have to come in once a month for the first six months of use. This would cost $50 per visit, again payable at the time of the appointment.

Next you must send in $50 to get the state ID card.

Once that arrived, I had to find a dispensary. There was one about a half an hour from my home.  I called first to make sure they were open. They were very nice, but the feeling of doing something untoward was hard to ignore. I watch Law and Order. The drug dealers invariable say they have “product.”

“Are you open yet?” I asked the receptionist at the dispensary. “Yes. But we are out of product at this time.” Product? But this is supposed to be a legitimate medical medication, not something clandestine.

Product? But this is supposed to be a legitimate medical medication, not something clandestine.

I went as soon as they had “product.” When I arrived, another person was waiting outside at the entrance, where there was a security guard. He looked at me and said, “Sorry you have to wait outside. We're only allowed to let one person in at a time.”

A security guard? I get that. You never know who might try to worm their way in. But I had the ID card. Why did we have to wait outside before each person was cleared?

Inside was lovely. Nice personnel, a waterfall, plants, real wood tables, coffee, tea and cookies waiting for us on a sideboard. It almost puts you off balance. A security guard at the door. Only one customer inside a time. Is something nefarious going on? But once inside it is warm, embracing and inviting.

I was escorted to a private room, where I spoke with the dispensary pharmacist. She explained how the medication works and what would be best for me, at least to start with. After the consultation I went back to the dispensary room.

The cost was less than I expected. Again, the fee was required at the time of purchase. It was cash only, no checks and no credit cards. Just like with a drug dealer. Apparently, banks are not able to accept checks or credit card charges because of the federal prohibition against marijuana.

Aside from feeling like I was doing something wrong, because of the urine test, security guard, “product” and cash up front, I am glad I tried it. The product I bought has not helped my pain, but the good thing is there are other concentrates and combinations I can try.

It is ironic that there is this war on opioids, yet marijuana remains a Schedule I controlled substance, making it very hard for researchers to get permission to study it. Studies that are available show it helps many disorders, including some forms of chronic pain  If the government truly wanted to help us get off opioids, they should make marijuana readily available for study and for patients..

Then, for many of us, there would be one more avenue of hope.

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.

‘Don’t Punish Pain’ Rallies Set for Saturday

By Pat Anson, Editor

Dozens of protests are being planned across the United States this Saturday to draw attention to the plight of patients suffering from chronic pain and illness.

The “Don’t Punish Pain” rallies were organized by a grassroots group on Facebook and quickly gained traction in the pain community – where there is growing frustration over reduced access to pain medication and medical care.

“One day we were talking and decided we could have a rally. And it went from there. It just exploded,” says David Israel, a 30-year old Michigan man disabled by chronic pain.

Israel says the group is planning rallies in 47 states – mostly at state capitols – and has obtained the necessary permits. For a complete list of the times and locations, click here.

The primary goal of the rallies is to get the Centers for Disease Control and Prevention to change its opioid prescribing guidelines, which have caused many doctors to stop treating patients with opioid medication or to drastically lower their doses.

“There are millions of people that are being affected by this. Not only do we need to get the CDC to change but we also need to get help for the people who’ve been abandoned,” says Israel.

Israel was recently abandoned by his doctor and has been unable to find a new one, in part because of a disputed drug test. He suffers from hydrocephalus, a condition that causes spinal fluid to build up in his brain, leading to headaches and other neurological problems.

“I don’t have a doctor at all right now,” said Israel. “I need pain meds, but I don’t have any because there was a false positive last year that I proved was false, but the doctor said there was no such thing as a false positive. She dropped my pain meds overnight.”

Some patients have complained to PNN that the rallies are poorly organized and they don't know who to contact or where to get further information. Perhaps the best thing to do is to join their Facebook group by clicking here and see if the information has already been posted.

The Don’t Punish Pain rallies were organized in the last few months without support or funding from other patient advocacy groups. It truly is a grassroots effort, supported by volunteers like Rhonda Posey, a Texas grandmother who suffers from arachnoiditis, a chronic spinal condition.

“It’s been fun to be involved with it, but it’s been quite a job,” says Posey, who helped organize the Don’t Punish Pain rally at Dallas City Hall Saturday morning. She was unable to get a permit at the state capitol in Austin, possibly due to the stigma associated with opioids.

“We had to have legislator sponsorship (for a permit). And we reached out to probably a dozen people trying to get someone to sponsor us and nobody would do it,” she told PNN. “They probably didn’t want their name associated with something like that.  

“Dallas has been very nice. Someone will be there with us the entire time. They’ve been real nice about everything, so it’s worked out well.”

Posey has also been successful in getting some advance media coverage of the rally from local newspapers and from KTRE-TV.  Her group plans to bring 50 pairs of shoes to the rally to represent patients who have died from suicide or medical conditions caused by untreated pain. 

She and Israel say it is time for different tactics by the pain community. Just signing petitions and writing letters to politicians about how the government’s response to the opioid crisis is hurting patients hasn't been effective.

“Nobody’s got the guts to standup and say wait a minute, there are other people suffering. It’s not just people that are suffering form addiction. It’s not just the families who are suffering from people who have died from overdoses," Posey said. “What about me? What about the millions of chronic pain patients that are suffering? What about us?”