FDA Approves New Inhaler for Migraine

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new type of inhaler for the treatment of acute migraine in adult patients with or without aura.

Onzetra Xsail delivers a low dose of a dry powder formulation of sumatriptan, the most commonly prescribed medication for migraine.

"Onzetra Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people," said Roger Cady, MD, director of the Headache Care Center and associate executive chairman of the National Headache Foundation.

"The Xsail Breath Powered Delivery Device allows the medication to be deposited deep into the nose, an area that is rich with blood vessels. By delivering the medication here, Onzetra Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat."

The inhaler is activated when a user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. The medication is dispersed deep into the nasal cavity, reaching areas where it can be rapidly absorbed.

As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduces gastrointestinal absorption.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

“While there are many acute migraine treatment options available, more than 70% of patients are not fully satisfied with their current migraine treatment. Given this high dissatisfaction, there remains an unmet need to provide patients with fast-acting, well tolerated therapies that deliver consistent relief,” said Stewart Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth.

The FDA approved Onzetra after clinical trials showed the inhaler provided headache relief to about 40% of users within 30 minutes. About two-thirds of users reported pain relief after two hours. Side effects include abnormal product taste, nasal discomfort, rhinorrhea and rhinitis.

How I Found Hope for Fibromyalgia

By Lynn Phipps, Guest Columnist

The year 2004 began for me a decade-long nightmare. Bedridden with severe body pain and disabled from 3 migraines per week, I lost my career as a social worker, ironically working with people with disabilities. I lived with severe pain and bone crushing fatigue daily.

Before I became ill, I didn’t believe in fibromyalgia. I was so wrong.

My diagnosing physician treated me with the standard medications for fibromyalgia, chronic fatigue, post traumatic stress disorder, migraines, anxiety, depression, and pain. None of the three FDA approved fibromyalgia medications worked. A combination of Norco and Butalbital taken every 4-6 hours managed the pain and migraines, giving me some ability to function.

Over time, I was able to take the pain medications less often, every 6-7 hours. I was taking care of my hygiene, my family and home again. The pain medications allowed me to move more, which is essential for managing fibromyalgia pain. I began exercise again for about ten minutes a day.

I remained his patient for 7 years until he yelled and humiliated me when I asked for a prescription for one migraine pill while out of town. I had forgotten to pack mine. He treated me like a drug addict and called me a liar. I was stunned, as that was the only time I had ever asked him for pain medication. I fired him.

Only one physician out of thirty was willing to take my case because it was so complex. I had to wait eight months for an appointment.

lynn phipps

In the meantime, I was seen by a PAC (physician assistant, certified) at a local clinic. I also tried alternative therapies such as acupuncture, massage, and herbal remedies. I tried hydrotherapy, saw countless physical therapists and chiropractors, all claiming they could cure me. Nothing worked. I was becoming fatigued to the point that I could no longer drive to my appointments. Discouraged, I gave up all hope of getting better.

I was referred to a pain specialist whose specialty was to find the nerves causing the headaches and cauterize them. The theory was that scar tissue would then form on the nerves, blocking the pain. It didn’t work. I was afraid at every appointment that he would stop prescribing Norco because he did not believe in pain medication. One year later, he did.

I couldn’t believe that a pain specialist would take away all of my pain medications. I hadn’t misused or abused them. I took less than prescribed. It was cruel. He helped me titrate off of Norco, because studies indicate they cause rebound headaches. He was right, but I was still in so much pain that I was not functioning. Two years with no pain relief had him referring me to a pain psychologist.

The pain psychologist determined that I was not a meanderer; that, in fact, my pain was legitimate. Vindication! He then changed my life by telling me that if I were ever to get well, I had to go to a larger metropolitan area.

A google search led me to an MD in San Francisco who specializes in treating fibromyalgia. A fibromyalgia patient herself, she understood my diagnosis. She explained that she got her life and career back after two years on something called the Guaifenesin Protocol, which includes taking an expectorant drug to clear airways in the lung. It was not a cure, but followed precisely, would reverse the fibromyalgia symptoms.

The basic principles of the Guaifenesin Protocol include finding the proper clearing dosage, eliminating the use of all salicylates (a natural chemical found in plants, as well as household and hygiene products) and following a low-carbohydrate hypoglycemic diet to combat low blood sugar, which mimics many fibromyalgia symptoms.

The Guaifenesin Protocol helps sluggish kidneys excrete the build up of phosphates, which are believed to be the cause of fibromyalgia symptoms, at a rate of six and a half times faster than without it. Over time, this leads to the reversal of fibromyalgia symptoms.

For the first time in three years, I felt hopeful. The doctor examined me and agreed with the  fibromyalgia diagnosis, stating I was one of the worst cases she had seen. She also reviewed recent lab work, discovering that my blood sugar was slightly elevated. She suggested a hypoglycemic diet. Within 6 weeks of the diet, I had more energy and less pain.

I have been taking Guaifenesin and following a hypoglycemic diet for 14 months. Before I made these changes, I had 62 of the 68 most generally accepted Fibromyalgia symptoms.

I now have only 14 fibromyalgia symptoms. I am taking only four prescription medications instead of thirteen. I am off all pain medications. And I am no longer bedridden.

Lynn Phipps lives in northern California with her family. Lynn has a degree in social work and is currently helping fibromyalgia patients navigate the Guaifenesin Protocol at FibromyalgiaWellness.info.

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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Will ‘Secret Deliberations’ Lead to Lawsuit Against CDC?

By Pat Anson, Editor

The Washington Legal Foundation is “keeping its options open” on a potential lawsuit to block the Centers for Disease Control and Prevention (CDC) from implementing its controversial guidelines for opioid prescribing. At issue is whether the CDC violated the Federal Advisory Committee Act (FACA) by developing the guidelines in secret and with little public input.

The CDC contends the guidelines are urgently needed to stop the so-called epidemic of opioid addiction and overdoses, while millions of chronic pain patients fear they will lose access to opioids if the guidelines are adopted.

Last week a “workgroup” appointed by the CDC recommended to the agency’s Board of Scientific Counselors (BSC) that the guidelines by adopted with few changes. The 10-member workgroup spent only three weeks reviewing a dozen complex guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. The panel met four times during that period and all of its meetings were closed to the public.

“Why is CDC so afraid of transparency here? That’s my question,” asked Mark Chenoweth, general counsel to the Washington Legal Foundation (WLF), a pro-business group that has threatened to sue the agency for its “culture of secrecy” and “blatant violations” of FACA.

FACA clearly states that “each advisory committee meeting shall be open to the public,” as well as any records, reports, minutes or other documents provided to or created by the committee.

The CDC has taken the position that the BSC is an advisory committee, but the workgroup is not.

“The BSC charged the workgroup with developing a report of its observations on the draft guideline and its underlying evidence,” said CDC spokesperson Courtney Leland. “Under FACA, the time for public input is when the BSC meets to deliberate on the work prepared by the workgroup.  This meeting, held on January 28, was a public meeting announced in the Federal Register, and included a public comment period.“

But the WLF’s legal team disputes that interpretation of the law.

“I don’t see why you can provide input to the government through secret deliberations simply because you’re providing your advice to an advisory committee rather than to the government itself. The whole point of the law is to make sure that advice that comes to the government and is relied on by government is a product of open deliberations,” said WLF chief counsel Richard Samp, who believes the guidelines were quickly reviewed to prevent any further delays in their implementation.  

The CDC planned to adopt the guidelines in January, but was forced to delay them after widespread criticism about its secrecy and lack of transparency during the guidelines' development.

“They want this to go on quickly. Obviously their existing advisory committee doesn’t have the expertise on its own, so it had to go outside of its ranks to do it,” said Samp. “But it realized that if the group was going to meet four or five times, it was going to drag on for months. And so the only way to do it quickly was to do what they have done.”

“If one wanted to test the legality of this sort of working group workaround on FACA, this is an excellent fact pattern on which to test it,” said Chenowith.

Asked by Pain News Network if the WLF would go to court before or after the guidelines are implemented, Chenowith and Samp were non-committal, but hinted they were prepared to take action in federal court in Atlanta, where the CDC is based.

“It never does any good to wait until final agency action. By that time people have really suffered some severe damage,” said Samp. “I assume one’s interest in these sort of cases is to prevent the agency from adopting guidelines and that’s why you sue early to try to prevent them from taking into account the recommendations before they make their final decision. One could easily file that in federal district court in Atlanta if one wanted to.”

WLF has a lengthy history of taking the government to court for regulations and laws effecting free speech, the environment, health care, and drugs. WLF describes itself as a public interest law firm “that regularly litigates to ensure that federal administrative agencies comply with statutes designed to ensure procedural fairness.” It often supports business groups and companies in litigation against  government agencies, and has represented or acted in behalf of pharmaceutical companies such as Johnson & Johnson and Purdue Pharma, the maker of OxyContin. 

"We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants," a spokesman for Purdue Pharma told Pain News Network.

That connection to a major opioid producer has led to insinuations that WLF and other organizations that accept funding from the so-called “opioid lobby” are somehow tainted. That charge is often made by Physicians for Responsible Opioid Prescribing (PROP), which supports the guidelines and had some of its board members on CDC committees that helped draft them.

A recent story by the Associated Press pointed out that nearly a third of the members of the Interagency Pain Research Coordinating Committee have financial connections to opioid makers. That same committee criticized the CDC for developing the opioid guidelines with little scientific evidence to support them.

“The apparent conflicts of interest on the panel underscore the pervasive reach of pharmaceutical-industry dollars, even among federal advisers who are supposed to be carefully vetted for such connections before serving,” the AP story said.

The article failed to point out that some of the committee members most critical of the CDC are federal employees of the Food and Drug Administration and the Agency for Healthcare Research and Quality (AHRQ), who as government workers are not allowed to accept financial contributions.

“I would be remiss and I’m certain so would many of my government colleagues if I didn’t go back to my director and say there’s a report coming out of the CDC that has very low quality of evidence,” said Richard Ricciardi, AHRQ, during a December meeting. “That’s an embarrassment to the government.”

The AP story also didn’t mention that the CDC itself has a foundation that accepts funding from healthcare companies such as Abbott Laboratories, Amgen, Medtronic, Johnson & Johnson, Merck, Quest Diagnostics and Pfizer, some of which stand to benefit from stricter opioid guidelines because they offer non-opioid treatments for chronic pain. The CDC Foundation accepted over $157 million from donors last year.  

Where Are the Voices of Pain Patients?

By Maureen Wilks, Guest Columnist

It seems that every day there is another news item on either prescription drug overdose deaths or the rise in heroin overdose deaths.  These stories tug at our hearts, the heartbreak of the loss of a vibrant teenager or young adult to prescription drugs and/or heroin.

But where are the stories of the pain patients? Where is the voice of my husband who lived stoically for over twenty years with chronic pain? He bravely kept moving forward always hoping for the pain to abate. He tried all the treatments, countless treatments over endless years. Multiple physical therapists, acupuncturists, chiropractic adjustments, massage, herbal remedies, herbal wraps, yoga, meditation and prayer. But his pain persisted.

He took all the non-narcotic medication prescribed. None helped with the pain, but the side effects added insult to his pain. Some made him feel like a zombie, not himself. Those I made him stop.

Some made him sick to his stomach, others he listed to the right, and a few made ringing noises in his ears and brain. One had him sweating so much that by morning his pillow was wet. Many of them left him feeling zoned out, listless and mentally uncomfortable, and all the while the pain continued, poorly managed, becoming its own disease.

Finally a doctor listened to his life story and prescribed opioids, along with physical therapy. Over the following months his pain backed down, and his life was bearable, and he moved back into the world to participate with friends and family; to go for walks and camping trips that had become impossible to bear.

MAUREEN WILKS

And then we read of research, or lack thereof, that concludes opioids do not work on long term chronic pain. I think of my husband and all the patients I have met over the past ten years as an advocate for chronic pain patients in New Mexico and I want to scream

How can you make such broad sweeping statements? How can you ignore the voices of patients whose lives have been transformed by opioids and have lived with them for many years? How can you place all chronic pain patients into one simple neat little box, wrap it up and throw away the key for a chance of happiness for intractable chronic pain patients? 

Because this is exactly what the latest guidelines from the CDC will do.

When dosing guidelines are implemented, even if you acknowledge the exceptions simply from a legal perspective, it will be a brave doctor that will prescribe above the guidelines. Because if anything were to happen to a patient under their care and they were not following the guidelines, they will face an uphill battle in the law courts of this country. And they know it, and so they will cut back, and patients will be abandoned.

The thrust of all the current research is to come up with as many reasons not to prescribe, while all the time avoiding the number one reason to prescribe, which is to manage pain. Hyperalgesia, low testosterone, constipation and the list goes on. But let’s be honest here. Every drug on the market can have some pretty awful side effects. Just read the list on the information sheet. My husband experienced many of these firsthand, taking the non-opioid anti-depressants and anti-convulsants. It is estimated that NSAIDS kill 16,000 patients a year.

When my husband’s pain was managed, he applied a testosterone cream, and ate a high fiber diet to keep regular bowel movements. And yes, our sex life may have diminished; we always had a great intimate relationship, kissing, cuddling and abundant laughs. But when his pain medication was abruptly taken away in 2011, pain became the overriding aspect of his life. It impacted our relationship so much more; pain overrode all desires.

In 2012, my husband was diagnosed with a choroidal melanoma in his left eye. As we waited to talk to a surgical oncologist at UNM Cancer Center, I picked up a booklet published by the National Cancer Institute: Support for People with Cancer-Pain Control. It states the following about Cancer-Pain Control:

“Over time, people who take opioids for pain sometimes find that they need to take larger doses to get relief. This is caused by more pain, the cancer getting worse, or medicine tolerance.  When a medication doesn’t give you enough pain relief, your doctor may increase the dose and how often you take it. He or she can also prescribe a stronger drug. Both methods are safe and effective under a doctor’s care.”

No one disputes the effectiveness of opioids in the treatment of acute pain, hospice, palliative and cancer pain. My husband did not have pain associated with his eye cancer, so he could not be treated under their pain guidelines. Radiation treatment did not stop the tumor's growth and he had to have his eye removed. No other cancer was detected in his body.

In reality though the cancer had already spread and two years later by the time two large tumors were detected in his liver, his life of suffering was almost over. In the last five weeks of his life he was given the much needed drugs to manage the pain that was still throbbing at the base of his neck and had now spread to his liver. The last two years of his life were quite frankly miserable, and this sweet gentle man deserved so much more.

Addiction is a serious concern and does need to be addressed. I believe training and education on opioid prescribing, and a strong mental health component are absolutely essential in treating chronic pain patients to prevent addiction from happening. Researchers need to recognize that chronic pain encompasses a multitude of diseases, injuries and mental health issues, and lumping broad groups together is poor science.

Reducing overdose deaths is not quite as simple as reducing access to prescription drugs. If it were, then there should be a correlation between overdose deaths within a state and the amount of opioids being prescribed.

New Mexico ranks number two in overdose deaths, but only 22 when it comes to prescribing (1 being lowest, 50 highest). I live in a county where 27% of the population lives in high poverty; defined as one in which 20% or more of the population has lived in poverty for 30 years or more. 44% of families had parents without full-time, year round employment. New Mexico ranks 49th to 50th for alcohol related deaths.

We have a fragile population and understanding and treating chronic pain within this population requires careful management and better access to mental health care. At the same time, we cannot and should not put limits on the use of opioids for treating pain patients, but need another layer of education, safety and adherence to both patients and prescribers.

The hundreds of thousands of chronic pain patients living in America deserve better than what the CDC guidelines propose.

Maureen Wilks is a Senior Geologist, and Head of Archives and Collections at the New Mexico Bureau of Geology and Mineral Resources.

Her husband Bob Macleod lived with chronic pain for over 20 years before his death in October 2015. Maureen is writing a book about their experiences, “A Pain in the Neck: The impact of prescription drug abuse on the treatment of chronic pain patients in America”.

This column is republished with permission from Dr. Jeffrey Fudin’s blog.

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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Wide Disparity in Opioid Doses in Veteran Overdoses

By Pat Anson, Editor

The difference between controlling chronic pain and risking an opioid overdose can vary widely from patient to patient, according to a new study that found the threshold for safe prescribing may be lower than many doctors think.

Researchers at the University of Michigan Medical School and the Veteran Administration’s Ann Arbor Healthcare System studied the medical records of 221 veterans who died from accidental opioid overdoses and compared them to an equal number of veterans who took opioids for chronic pain, but did not overdose.

The average dose that the overdose victims had been prescribed was over 70 percent higher than what the comparison group received. The average daily dose for the overdose patients was 98 MEM (morphine-equivalent milligrams), compared to about 48 MEM for those who did not overdose.

But the researchers did not find a specific dose that clearly differentiated between patients at risk and those not at risk for overdose. In fact, some overdose victims had prescriptions for well under 50 MEM daily.

Despite that discrepancy, the researchers recommend lowering the recommended dosage threshold below 100 MEM. Lowering the number of high doses, they say, would help more people than it hurts.

“As the United States grapples with the rising toll of accidental overdoses due to opioids, our findings suggest that changing clinical practices to avoid escalating doses for patients with chronic pain could make a major difference in the number of patients who die,” said first author Amy Bohnert, PhD, an epidemiologist at the University of Michigan.

Bohnert was part of the “Core Expert Group” that helped draft the CDC’s controversial guidelines for opioid prescribing. Two co-authors, Joseph Logan and Deborah Dowell, work at the CDC’s National Center for Injury Prevention and Control, which oversaw the guidelines’ development.

The CDC guidelines recommend that primary care physicians start at the “lowest effective dosage” of opioids and should avoid increasing dosages over 90 MEM. Even a daily dose as low as 50 MEM increases overdose risk, according to the guidelines.

“Avoiding prescribing large doses also has the benefit of reducing the amount of the medications going to patients’ homes that has the potential to be taken by others who live with the patient, like children and teenagers,” said Bohnert. “This is important because an opioid that is a larger dose per pill, compared to a smaller one, is going to be deadly to a child or adult who hasn’t been taking the medication regularly.”

The study, which was funded by the Veterans Administration, is published in the journal Medical Care.

The study was based on the veterans’ medical, pharmacy and death certificate records. It did not include those who died by suicide using opioids, or veterans receiving hospice or palliative care.

Veterans were selected only if they filled a prescription for an opioid medication and had a diagnosis of chronic pain during the years 2002 to 2009. The researchers included veterans who had been prescribed codeine, morphine, oxycodone, hydrocodone, oxymorphone, hydromorphone, fentanyl, meperidine, pentazocine, propoxyphene, or methadone.

Under a federal spending bill passed by Congress and signed into law by President Obama, the Veteran’s Administration is required to follow the “voluntary” CDC opioid guidelines. The VA provides health services to 6 million veterans and their families. Over half of the veterans treated by the VA are in chronic pain.   

Players Say Half of NFL Using Medical Marijuana

By Pat Anson, Editor

With the countdown underway for Super Bowl 50, there’s a renewed focus on the NFL’s high rate of injuries and concussions, and whether the league should be open to players using medical marijuana to treat their pain.

“The growing legality of the plant, especially for medical use, is putting the NFL into a bit of a moral quandary,” says former Denver Broncos wide receiver Nate Jackson.

“When you compare it to what the alternative is in their training rooms; pills, pills, pills, that are being put into these guys’ hands and turning them into addicts. I was never big on those pills. I medicated with marijuana and it helped me and I think it helped save my brain.”

Jackson suffered numerous injuries during his six years in the NFL, breaking several bones and suffering at least two concussions. After retiring, Jackson wrote a memoir about his football career, Slow Getting Up: A Story of NFL Survival from the Bottom of the Pile and became an advocate for medical marijuana.

Pain News Network recently spoke to Jackson at the Cannabis World Congress & Business Exposition in Los Angeles, where he told us he started smoking marijuana as a high school football player and has been using it ever since.

nate jackson

“It’s been pretty effective. It didn’t prevent me from getting to the NFL. It didn’t prevent me from excelling and being my best. It was an effective way to take the edge off, deal with pain, and deal with injuries without taking away my edge on the field,” said Jackson. “I would say probably half the guys (in the NFL) use marijuana. They’ve been using it since they were teenagers. They’re familiar with what it does with their bodies. Top level athletes, you tinker with the process as you go, with your body, with your performance, with what works for you and what doesn’t.

"So if these guys get into the NFL with a marijuana habit intact, it means that it’s under control, it’s actually something that works for them, works for their body, allows them to perform at the highest level they can, and it doesn’t affect them negatively. Because if it does affect them negatively, they get cut. The demands of the job are so strict and so intense, if you’re not playing well, you get cut. And so if they are in the league, they are playing really well. They’re punctual, they’re memorizing their playbook, and they’re taking care of their business. If they’re using marijuana to do that, I think it’s healthy.”

Although the NFL has a reputation as a league that closely monitors players for signs of illegal drugs or performance enhancing medication, Jackson says it’s relatively easy to avoid getting caught by a drug test.

“Because the street drug test is only once a year. It’s in May, June or July somewhere around there. Once you get it, then you’re good for the next year, as long as you don’t fail it. I never failed it,” he said.

“The problem is for those guys who get put into a substance abuse program. That could be because of a positive marijuana test or DUI or ephedrine or Adderall or domestic dispute program, whatever it may be. You get put in the substance abuse program and I would say there are maybe a couple hundred guys in the league who are in that program and you get tested. You’re urine tested three or four times a week, every week, all year long for several years.”

Several current players support Jackson’s claim that at least half of the NFL is using marijuana. They told the Bleacher Report that many players smoke marijuana three or four times a week during the season. None of the players wanted to be identified.

"It's at least 60 percent now," said Jamal Anderson, a former running back for the Atlanta Falcons. "That's bare minimum. That's because players today don't believe in the stigma that older people associate with smoking it. To the younger guys in the league now, smoking weed is a normal thing, like having a beer. Plus, they know that smoking it helps them with the concussions."

Former Chicago Bears quarterback Jim McMahon says medical marijuana helps him deal with severe headaches, depression, memory loss and early onset dementia – which he blames on the NFL’s negligence in handling concussions during his playing career. McMahon said he was taking 100 Percocet pills a month for pain before he started using marijuana.

"They were doing more harm than good," McMahon told the Chicago Tribune. "This medical marijuana has been a godsend. It relieves me of the pain — or thinking about it, anyway."

With about 300 players being put on injured reserve every season – many with career ending injuries – Nate Jackson says it’s time for the NFL to acknowledge what’s already happening and change its marijuana policy.

“I think they (injured players) should be given a choice at that point and be able to avoid the opioid painkillers, which are pretty much a scourge in the locker room,” Jackson says.

“When you get put on injured reserve, if you have a severe enough injury that your season is over, you’re going to be given drugs by the team doctors and the team trainers because you are legitimately hurt. Are you going to take those pills or are you going to take something else? I chose to take something else.”

Lyrica and Neurontin Face UK Restrictions

By Pat Anson, Editor

Two drugs often recommended as safer alternatives to opioid pain medication could face new restrictions in the UK because of increasing reports they are being abused.  

British health officials say the prescription drugs pregabalin and gabapentin, which are sold by Pfizer under the brand names Lyrica and Neurontin, are being used by drug abusers to get high, resulting in dozens of overdose deaths.

Since 2012, at least 38 deaths involving pregabalin and 26 involving gabapentin have been reported in the UK.

The prescribing of pregabalin and gabapentin in the UK has soared by 350% and 150%, respectively, in the last five years.  Both medications are anti-seizure drugs widely prescribed to treat epilepsy, neuropathy, fibromyalgia and anxiety.

The UK Advisory Council on the Misuse of Drugs (ACMD) is recommending that gabapentin (Neurontin) and pregabalin (Lyrica) be reclassified as Class C controlled substances – which would mean prescriptions would only be valid for one month and there can be no refills.

“Both pregabalin and gabapentin are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants, they can cause drowsiness, sedation, respiratory failure and death,” said Professor Les Iverson, ACMD chairman, in a letter to Home Office ministers.

“Pregabalin may have a higher abuse potential than gabapentin due to its rapid absorption and faster onset of action and higher potency. Pregabalin causes a ‘high’ or elevated mood in users; the side effects may include chest pain, wheezing, vision changes and less commonly, hallucinations. Gabapentin can produce feelings of relaxation, calmness and euphoria. Some users have reported that the ‘high’ from snorted gabapentin can be similar to taking a stimulant.”

The letter warns there is a risk of addiction for both drugs, as well as misuse and diversion.

“The use of gabapentin and pregabalin by the opioid abusing population either together or when opioids are unavailable reinforces the behavior patterns of this high-risk population. There is a high risk of criminal behavior stimulated by the wish to obtain gabapentin and pregabalin,” said Iverson.

Lyrica is Pfizer’s top selling drug and generates worldwide sales of over $5 billion annually. Pfizer said the recommendation to reclassify the drugs and limit their prescribing could be harmful to patients.

“We are concerned that the advice contains a number of inaccuracies and some potentially misleading information, and is contrary to the totality of the safety data available for pregabalin and gabapentin,” the company said in a statement reported on the Pulse website. “Controlling the supply of these products across the whole UK, would be a disproportionate measure that would impact on patients and their quality of life, and could also result in additional economic and operational burden on an already strained healthcare system.”

Earlier this month a study of 440 drug abusers in Ireland found that 39 tested positive for pregabalin in their urine. Only ten of them had been prescribed the drug. Other drugs detected in pregabalin positive patients were opiates, cocaine, benzodiazepine and cannabis, according to the Irish Examiner.

The study called the abuse of pregabalin a “serious emerging issue.” Recreational users of pregabalin in Belfast call the drug “Budweisers” because it induces a state similar to drunkenness.

Neurontin (gabapentin) is approved by the FDA to treat epilepsy and neuropathic pain, but is widely prescribed “off-label” for a variety of other conditions, including depression, migraines, fibromyalgia and bipolar disorder. In 1999 a Pfizer executive was so mystified by Neurontin’s growing use he called it the “snake oil of the twentieth century.”  

Chronic Pain Changes Our Immune Systems

By Pat Anson, Editor

Scientists already know that chronic pain can change the way our brains work, but now there is new evidence that pain may also make lasting changes in our immune systems.

In studies on laboratory rats, researchers at McGill University in Montreal found that chronic pain alters the way genes work in the immune system. The discovery may help explain why pain can persist long after the initial injury.

"We found that chronic pain changes the way DNA is marked not only in the brain but also in T cells, a type of white blood cell essential for immunity,” said Moshe Szyf, a professor in the Faculty of Medicine at McGill. "Our findings highlight the devastating impact of chronic pain on other important parts of the body such as the immune system."

McGill researchers examined DNA from the brains and white blood cells of rats nine months after a nerve injury. They found a “stunning” number of changes in DNA methylation – which regulates how genes function. Chronic pain appeared to reprogram how the genes work.

"We were surprised by the sheer number of genes that were marked by the chronic pain -- hundreds to thousands of different genes were changed," adds Szyf. "We can now consider the implications that chronic pain might have on other systems in the body that we don't normally associate with pain."

Many of the genes that were altered are associated with depression, anxiety, and loss of cognition, which are some of the negative side effects of chronic pain.  The findings could open new avenues to diagnosing and treating chronic pain in humans, as some of the genes affected by chronic pain could represent new targets for pain medications.

“These findings reveal potential new avenues for the development of novel therapeutics directed at either the molecular regulation of methylation or at key genes or pathways dysregulated in chronic pain,” the study found.  “This work also provides a possible mechanistic explanation for commonly observed comorbidities observed in chronic pain (i.e anxiety, depression). Finally, the sheer magnitude of the impact of chronic pain, particularly in the prefrontal cortex, illustrates the profound impact that living with chronic pain exerts on an individual.”

The McGill study is published in the journal Scientific Reports.

A recent study at Northwestern University found that chronic pain “rewires” a part of the brain that controls whether we feel happy or sad.  Researchers found that a group of neurons thought to be responsible for negative emotions became hyper-excitable within days of an injury that triggers chronic pain.

How to Stop Hospital Horrors

By Ellen Lenox Smith, Columnist

I am guessing many readers will be able to relate to this topic -- the horrors of being in a hospital with a complicated chronic condition like mine, Ehlers Danlos syndrome. Whether it is a planned surgery or an emergency visit, patients who do not fit into a “neat box” often find that staying in a hospital can be insulting, frightening, and at times dangerous.

If you are reading this as a medical professional who works in a hospital, I hope you will think about what it is like to be a patient in this circumstance and consider helping to change the staff’s attitudes and ways.

I will share three short stories to help you to begin to understand the horrors that can happen.

One of the most horrifying things my husband and I faced was when we flew from our home state of Rhode Island to Wisconsin to have my feet reconstructed. My life, after the surgery, was to be five months in a wheelchair, non weight bearing. It was not an easy assignment to face.

After the successful surgery, a hospital social worker was assigned to find a safe rehabilitation center for me until I was strong enough to  travel back home.

She arrived in the room four mornings later to announce that not one place would accept me because I was “too complicated” due to my drug and food reactions. As a result, I was to be discharged to home. We were sent that afternoon to a motel that turned out to be filthy. I had to use a bedpan since I was no longer able to walk and then flew home the next day. It was humiliating and also dangerous to send me home just a few days after major surgeries, but we had nothing we could do to change this.

Lesson Learned: I did, in time, write to the president of the hospital to let him know how unacceptable this treatment was. From that point on, we were given a wonderful team to help make sure this never happened again. We have returned year after year to the same hospital for my surgeries.

Another event was dealing with IV’s. Because of my condition, IV’s were difficult to hold in place and many times became infiltrated, sending medication into the surrounding tissue instead of the blood stream. One night I kept telling the nurse in charge of me that the IV was dislodged. I was told all was just fine, even though as he administered the pain medication into the IV it stung and made the location of the injection swell immediately.  

He said  to “get some rest, you are just tired.”  Well, I was right, the pain medication did not get into the blood. So, I had to suffer with unnecessary pain until an ICU nurse came down and was able to successfully get the IV catheter into a vein and stay there. This all happen in the middle of the night while I was in post op, exhausted and paying the price for a nurse not willing to listen to me and take me seriously.

Lesson Learned: Today, I no longer get an IV. We either use a PIC line or port for surgeries. They hold and work for me!

My next story involves a friend who was admitted to a hospital so sick that she was not able to get out of bed without passing out and going into seizures. Due to her complications, she was not able to get the care needed and was transported to Johns Hopkins Hospital. Within 24 hours, after a standard MRI while laying down, it was declared that she was to sit up, take the neck collar off, and be discharged.

The problem was the only way to get a true answer for what was wrong with her was to have an MRI while standing up.

After much hard work by her mom and husband, my friend was transported to Doctor’s Community Hospital; where it was determined, via the correct neurosurgeon who ordered the correct imaging, that she needed a neck fusion quickly to save her life. Yet, two hospitals wanted to discharge her home and felt she was just fine.

Lesson Learned: Be sure to get to a hospital that your skilled doctor has connections with. Don’t give up until you find the right doctor at the right hospital, for if my friend had listened to the first two places, she would not be alive today.

So what can we all do to change the potential of inappropriate treatment, or even no treatment at all?

1) Try to deal with your difficult issues, as much as you can, at home and with doctors you can trust, instead of running to a hospital. My husband and I have a pact to stay away from hospitals as much as we can to keep me safe, even though we both admit that we would so appreciate knowing we could go there safely for help.

2) If there is no choice but to go to the hospital, come as prepared as you can with files of your medical records, including lists of medications, medications you react to, supplements, diagnosis, previous surgeries, contact info for doctors that treat you, and tests done along with their dates and locations.

3) I have a packet of all this information that we keep in the car “just in case.” I also keep the records on my computer and can easily add new information when needed.

4) Make sure your doctor is part of the hospital you go to or is able to connect with the right people in the one you must get to.

5) If you have a negative experience, write the president of the hospital, not to just vent and complain, but with the intent to share issues of your care and to help educate in any way you can. Remember, if we just bad mouth them, we could potentially not be welcome at all. I had a phone call once from a local doctor who saw a negative Facebook post by a frustrated patient that included the doctor’s and the hospital’s names. The call was to ask me to take down the post, because the hospital staff were reading it and were really upset. The doctor told me we had to be careful how we dealt with this or people would reject taking us at all!

6) Write your congressman and share why being admitted to a hospital in their district is dangerous for you. If we don’t speak out, it continues and we suffer.

Unfortunately, we walk a fine line. We need to share these horror stories, but we have to be cautious how we do this. We want changes to happen, but we don’t want to turn people off by being so aggressive and so angry that they turn away from helping us or others like us in the future.

Education is constantly the theme; teach others what your condition is like, offer to speak out, and even consider a letter to the editor to share your concerns. But again, remember to think how you express these words. When somebody approaches you feeling extremely angry, you feel that vibration and want to back up. The medical team will feel this way too.

We have to be bigger people and put our anger aside to explain what it's like to be in our situation.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their 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.

Committees Support CDC Opioid Guidelines

By Pat Anson, Editor

Two advisory committees expressed broad support Thursday for the controversial guidelines for opioid prescribing being developed by the Centers for Disease Control and Prevention (CDC). Those guidelines discourage primary care physicians from prescribing opioids for chronic non-cancer pain and recommend other therapies such as over-the-counter pain relievers, acupuncture, and cognitive behavioral therapy.

One newly formed committee --- which the CDC calls a “workgroup” --- did express “significant concern” about the cost of those alternative pain therapies and whether they are covered by insurance. The workgroup's report to the CDC’s Board of Scientific Counselors (BSC) also suggested that the guidelines be “framed with positive rather than negative language” that supports “integrated care for people with chronic pain.” It also recommends the impact of the guidelines be monitored for “unintended consequences” after they are implemented. 

The BSC voted to support the workgroup’s report, which can be found here.

“The BSC voted unanimously: to support the observations made by the BSC Opioid Guideline Workgroup; that CDC adopt the guideline recommendations that, according to the workgroup’s observations, had unanimous or majority support; and that CDC further consider the guideline recommendations for which the workgroup had mixed opinions,” said CDC spokesperson Courtney Leland in an email to Pain News Network.

“CDC is taking the BSC’s recommendations, as well as comments received from the public, into consideration in revising the guideline. The guideline is a priority for our agency. Given the lives lost and impacted every day, we have an acute sense of urgency to issue guidance quickly.”

The CDC planned to implement the guidelines this month with little public input, but was forced to change course after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines. In response to critics, the 10-member workgroup was formed three weeks ago and met four times by teleconference to review the guidelines. A potential legal problem for the CDC is that none of the workgroup’s meetings were open to the public. The workgroup also reviewed the guidelines with outside consultants without publicly disclosing who they were.

The Washington Legal Foundation (WLF) has threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA), which requires meetings to be open to the public.

Over 4,300 online comments were received by CDC during a public comment period that ended earlier this month. Many opposed the guidelines as being too restrictive, while others wished the guidelines were stronger to combat the so-called epidemic of opioid abuse and overdoses.  There were passionate arguments on both sides, but in the end the workgroup decided that the case for the guidelines was stronger.

“Comments from patients and family members, in particular, expressed the desire that patient-centered care is enhanced rather reduced by these Guidelines. Members felt that the guidelines could be implemented in a manner consistent with patient centered care,” the workgroup said in its report.

As many as 11 million Americans use opioids for long-term chronic pain and many fear losing access to the drugs if the guidelines are adopted.

“The purpose of the guideline is to help to primary care providers offer safer, more effective care for patients with chronic pain and to help reduce opioid abuse disorder and overdose from these drugs,” said Debra Houry, MD, director of the CDC’s National Center for Injury Prevention and Control, which is overseeing development of the guidelines.

"The guideline itself is not a rule, regulation or law. It is not intended to deny access to opioid pain medication as an option in pain management. It is not intended to take away physician discretion and decision making.”

“Pain specialists and their patients fear the Guidelines will not be used that way though and adoption by boards, professional organizations, and insurers will pressure even specialty pain providers to taper patients,” said Anne Fuqua, a chronic pain sufferer and patient advocate. “Pain patients nationwide have been experiencing dose reductions and losing access to care altogether for several years, with the situation becoming more acute in the past year.  In an environment where physicians are tapering patient doses or ceasing opioid prescribing altogether, I feel these guidelines will serve like an accelerant in a growing fire.”

Although the CDC has said it doesn’t want the guidelines implemented until they are finalized, Fuqua said many doctors are already doing just that. She said her faith in democracy “took a swift kick in the teeth” as she listened to the workgroup’s presentation during a conference call. Fuqua was not given an opportunity to speak, although the president and founder of Physicians for Responsible Opioids Prescribing (PROP) were given time to address the BSC in support of the guidelines they helped draft.

“There were 28 comments supporting the Guidelines and 4 dissenters. One physician made statements partially supportive of our needs. CDC will no doubt use this ‘overwhelming support’ to justify adoption of the guidelines. I fear they see us as simply a casualty of war, much like those with tuberculosis who were quarantined to prevent disease spread. The only difference is that harming us doesn't save other lives,” she said.

CDC has not released a timetable on when it plans to finalize or implement the guidelines.

My Life as a Teen with Chronic Pain

By Stacy Depew Ellis, Guest Columnist

School, sports, music, catching up on the latest gossip. That is what I wish I could say my teenage years were filled with.

Don’t get me wrong, I had a great life. However, I was more concerned with being at school, when my last dose of medicine was, and how I was going to get up the stairs.

When I was in eighth grade, I had a traumatic accident in my dance class. After being misdiagnosed and put in a cast for almost three months, I was diagnosed with a chronic pain syndrome called Reflex Sympathetic Disorder (RSD) or CRPS.

I was sent to yet another doctor to see about treatment. It was decided that I would continue taking pain medication and start receiving lumbar injections. Little did I know that sleepless nights and several emergency room trips would also be included. I would be given more than the recommended amount of painkillers and would still be screaming in pain. Every trip back there offered more questions about a teenager being addicted to prescription drugs. Every doctor in town had seen me.

I started high school as a homebound student. I was going to school for my elective classes and seeing a teacher at my house for core classes. A lot of kids my age got hurt, most of them had a cast at some point. But my illness wasn’t visible; you couldn’t see anything wrong with me. I began losing friends and rumors spread like wildfire throughout my community and school. The worse my pain was, the worse the rumors were. It was tough, but I got through school.

STACY DEPEW ELLIS

After my 33rd spinal injection, I put a stop to the poking and prodding. The doctor hit a nerve and I was paralyzed from my shoulder to my finger tips for two days. Forty-eight hours of not moving an arm. Even more doctors came to see me and I started what would become the first of many steroid treatments.

Time went by and nothing got better. I had headaches, achiness, and started having trouble putting my thoughts into sentences. I saw a neurologist who once again started a smorgasbord of tests. Using my body as a human cushion was normal. What seemed like years of MRIs, spinal taps, and some things I have never heard of, led to the diagnosis of multiple sclerosis.

MS? Really? I was 21 years old.  My first round of treatment was a huge dose of steroids. I took 150 Prednisone pills followed by three days of IV steroids. My flare ups were bad, leaving me in the hospital for weeks at a time. I was a guinea pig for these pharmaceutical companies, injecting myself with a different medicine every month to see which worked best.

It was relieving to finally have a diagnosis and know what was wrong, but having MS is almost worse than not knowing. Heaven forbid I get sick and need to see a doctor. No one wants to treat someone with something like MS. Doctors immediately go to “it’s just the MS” and real problems get overlooked and never fixed. Honestly, the dentist even has trouble being your doctor.

I have been on medicine almost my whole life. I have been seen for depression and spent my paychecks on medical bills. There may never be a cure for multiple sclerosis and I may always be popping pills and injecting things into my stomach, but I am happy to say that I do my hardest to not let my disability hinder me. I try to not let it even be a part of me and I live my life to the fullest.

I will be on anti-anxiety medicine forever but I also believe that I can do anything that I desire. That is something that no doctor can ever take from me.

Stacy Depew Ellis lives in Alabama with her husband. Stacy proudly supports the Alabama-Mississippi National Multiple Sclerosis Society and the Ronald McDonald House Charity, which provided housing for Stacy and her mother when she was in a treatment program in Philadelphia.

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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Does Chronic Pain Define Us?

By Crystal Lindell, Columnist

The strangest part about having mental health issues is that it makes you wonder who you really are as a person — in your core.

Like if you’re feeling insanely anxious because of morphine withdrawal, does that make you an anxious person? Does that become part of who you are? Is that suddenly one of the many personality traits people will associate with your character?

Or, when you’re on morphine, and it changes you from a Type A person into a Type B person, is that who you are now?  Is that your personality?

Or what about when you’re in so much pain that your patience is gone, and you realize that you are being a total bitch to everyone within striking distance. Does that make you a bitch? Is that who I am now?

I honestly don’t know who I am now.

I’ve been feeling especially unsteady lately as I try to navigate a new-found glimpse of health where I have actual pain-free days, and as I also simultaneously try to go off morphine completely. It turns out long-term morphine withdrawal is so much more emotional than anyone ever tells you.

And it turns out that I actually have no idea who I am as a person anymore.

I’m working with a psychologist and a psychiatrist, and I’m trying to figure everything out. But it’s almost like I spent the last three years of my life so completely consumed with my health issues, that I lost my identity. 

Back when my parents got divorced, I remember being in a “kids from divorced families” support group about two years after everything first went down, and the woman leading the group asked me to tell everyone a little bit about myself. And I suddenly realized I didn’t know myself well enough to answer that question.

I remember lying and saying I was involved in things I used to be involved in, like theater. I realized in that moment that I had been walking through life with my head down, with my eyes on the ground for years, and I was trying to look up and see the world around me again. I’d been so consumed by my family’s issues that it literally hurt my eyes to look up. 

These days, the setting is different but the realization has been the same. I’m on a date, or writing a Twitter bio, or talking to my therapist, and I suddenly find myself unable to answer basic questions, like “What are you interested in?” “What do you like to do for fun?” or “How would you describe yourself?”

And it hits me, that for the second time in my life, I have no idea who I am.

I know what I’m not. I’m not a youth leader anymore. I’m not Type A anymore. I’m not independent anymore. I’m not even drug free, or a practicing Christian, or living in my own place.

But if I’m not any of those things, who am I?

They say that going through hard times makes you realize who you really are as a person. If that’s true, it turns out that this whole time I was an atheist, Type B, bitch.

But I’d like to believe something else. I’d like to think that hard times are like a fire, a hurricane and maybe a bomb -- all at once — and they just destroy everything in their path. Picking up the pieces means finding lots of damaged things. It means that for a while, everything is burned, and blown up and underwater. And that’s okay. It’s okay to be damaged.

The important thing is figuring out how rebuild, and creating something new from the wreckage. It’s about figuring out what I want my soul to look like now that it’s endured an explosion. I’m not sure yet who I will be when everything gets redone — I’m not sure who I want to be.

When 2016 started, I posted a quote on my Instagram, “What is coming is better than what has gone.” 

And I have to believe that whatever I choose to rebuild, it will be better than what the pain destroyed.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Recalled Lyrica Damaged By 'Extreme Heat'

By Pat Anson, Editor

Nearly 150,000 bottles of Lyrica are being recalled by Pfizer in the United States and Puerto Rico because they may have been damaged by "extreme heat" while being transported, Pain News Network has learned. Each bottle contains 90 capsules.

Pfizer ordered the recall of its blockbuster pain drug on January 11 and notified retailers that may have been shipped the damaged capsules, but made no effort to tell patients about the recall because the problem did not appear serious, according to the company. PNN learned about the recall when a “Dear Customer” letter sent to retailers surfaced.

“Even though the patient impact and safety risk are low, Pfizer has decided, out of an abundance of caution, to voluntarily recall three lots of Lyrica capsules at the retail level due to the potential presence of deformed or damaged capsules. Please note that the use of, or exposure to, this product is not likely to cause adverse health consequences,” the company said in a statement to PNN.

The Lyrica capsules were manufactured at a Pfizer facility in Freiburg, Germany and shipped to U.S. wholesalers in September or October of last year. Pfizer said it learned some of the capsules were damaged in mid-December.

"We believe this was a result of exposure to extreme heat during transit," the company said. “Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. There is no anticipated impact on supply. Pfizer will continue to meet product demand based on U.S. prescriptions."

Lyrica is Pfizer’s top selling drug, generates over $5 billion in annual sales, and is currently approved for use in over 130 countries. In the U.S. Lyrica is approved to treat epilepsy, diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injury. It is also widely prescribed “off label” to treat a variety of other conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults. Lyrica is the brand name of pregabalin, which was originally developed as an anti-seizure medication.

Three lots of Lyrica are being recalled. They include 50 mg capsules in 90-count bottles, Lot #M07861 and with an expiration date of 5/31/2018. Two lots of 75 mg capsules in 90-count bottles are also being recalled. Their lot numbers are #M07862 and #M07865, with expiration dates of 5/31/2018 and 6/30/2018.

Pfizer issued no press releases about the recall and there is no mention of it on the company’s Lyrica website or the Food and Drug Administration's website that lists recalled products. 

Pfizer says the manner in which it conducted the recall was approved by the FDA’s New York District Office. The company proposed that it be classified as a Class III recall, which the FDA defines as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

“Recalls are actions taken by a firm to remove a product from the market.  Only in rare cases will FDA request a recall. FDA's role is to oversee a company's strategy and assess the adequacy of the recall,” said Stephen King, an FDA spokesman who said the agency was still evaluating the effectiveness of the recall.

“Not all recalls are announced in the media or on our Recalls press release page.  FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard.”

Pfizer ordered the Lyrica recall just days after raising the listed price of the pain drug by 9.4 percent. Prices were also raised on over 100 of the company’s other drugs. Pfizer’s pharmaceutical division reported revenue of $45.7 billion in 2014.

#PatientsNotAddicts Campaign Launched on Twitter

By Ken McKim, Guest Columnist

There’s a hashtag coming to a screen near you: #PatientsNotAddicts. Its importance to the millions of people who suffer from chronic illness cannot be overstated.

Words matter. Words are powerful. They can educate, but they can also blind. They can sway the opinions of millions of otherwise thoughtful and intelligent people through nothing more than simple repetition, even if the information they repeat is patently false.

In a 1992 study by McMaster University researchers, it was shown that people give more weight to something they hear repeated over and over again, than something they have only heard once. People will do this even if the person repeating the information has proven untrustworthy in the past on multiple occasions. Repeat it often enough, and a lie becomes the truth.

We see this all the time in life. It’s why advertising exists, and why politicians will never completely stop using negative campaign ads. Its how one discredited doctor was able to scare the daylights out of millions of Americans about the so-called dangers of vaccines, thus leading to a resurgence of diseases that had previously been all but eradicated, like measles and whooping cough.

This same tactic is now being used against medications that give relief to millions of people who are fighting cancer and chronic illness: opioid-based painkillers.

There’s no better way to ascertain public opinion on a subject than by Googling it. In this modern century of seemingly unlimited information, Google serves as society's mirror, reflecting back to us the truth of how we feel about any given subject. It’s not hyperbole to say that as Google goes so does the world, and this is especially true when it comes to the subject of opioids.

A recent search of Google using just the word “opioids” found that 50% of the search results had to do with addiction and abuse. Only 4% of the results dealt solely with the proper use of opioid pain medication.

It’s plain to see that media coverage on the subject of opioids skews overwhelmingly negative, and the average person researching the topic will come away with an equally negative (and unknowingly distorted) opinion of them.

It’s this negative societal view that the CDC was probably counting on to divert attention from their covert attempt to issue new prescribing guidelines to severely limit the prescribing of opioids. The webinar they held on the subject last September was an invitation only affair. No press releases were issued, and the period of time allotted for public comment was a paltry 48 hours (which was laughable considering most of the public had no idea this was taking place). 

If not for the vocal pushback from the chronic illness community and organizations like the Washington Legal Foundation, these new guidelines would already be a fact of life for all United States citizens. Sadly, these guidelines are now the law of the land for our wounded veterans, as part of the $1.1 trillion spending bill passed and signed into law by President Obama last December.

Taking opioids for pain does not automatically turn you into an addict, any more than eating M&Ms turns you into chocolate.

Chronic illness may be invisible, but the chronically ill can no longer afford to be. That’s why #PatientsNotAddicts is important. Words are powerful and repetition can be a tool for the truth as well as for lies.

Using this hashtag can help remind everyone that pain patients are ordinary people. They are your loved ones, friends, neighbors and co-workers. What they want more than anything (except for a cure, of course) is to recapture just a small piece of the life they had before their illness took hold, before the never-ending pain of their condition destroyed the lives they had built for themselves -- lives that included careers, birthday parties, graduations, playing with their kids and being intimate with their spouses or significant others.

For hundreds of millions of people, opioids help them do just that. To deprive them of that small ray of hope in the name of “protecting them” is nothing short of inhumane.  I believe we are better than that, America. Prove me right.

Ken McKim is an advocate for anyone with a chronic illness, and has made more than 43 videos on topics such as Crohn’s disease, lupus, depression, Ehlers-Danlos Syndrome, Complex Regional Pain Syndrome and much more. You can see his videos at Don’t Punish Pain and on his YouTube channel.

Ken began advocating for pain patients when his wife was diagnosed with Crohn’s – and he came to realize that the chronically ill were often stigmatized by society. That realization led him to make a 32-minute video called "The Slow Death of Compassion for the Chronically Ill."

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.

Major Decline in Hydrocodone Prescribing

By Pat Anson, Editor

Prescriptions for Vicodin and other hydrocodone products declined dramatically in the United States after the opioid pain medication was rescheduled by the Drug Enforcement Administration to make it harder to obtain. But there may have been unintended consequences for cancer patients, according to a new study published in JAMA Internal Medicine.

In October 2014 the DEA rescheduled hydrocodone from a Schedule III controlled substance to a more restrictive Schedule II medication because of its “high abuse potential.”

The rescheduling limits patients taking Vicodin, Lortab, Lorcet and other hydrocodone combination products to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill.

In the first year after rescheduling, the number of hydrocodone prescriptions in the U.S. plunged by 22 percent, from nearly 120 million to 93.5 million.

“Dispensed hydrocodone combination product prescriptions decreased substantially after rescheduling by the US Drug Enforcement Administration, with 26.3 million fewer hydrocodone combination product prescriptions and 1.1 billion fewer hydrocodone combination product tablets dispensed in the year after rescheduling,” wrote lead author Christopher Jones, PharmD, U.S. Department of Health and Human Services. “Most of this decline was due to the elimination of hydrocodone combination product prescription refills, consistent with the prohibition on prescription refills for schedule II medications.”

The decline in prescribing was seen in almost all healthcare specialties, including primary care, surgery, dentistry, emergency medicine and oncology. Nearly 187,000 fewer prescriptions for hydrocodone were written for cancer patients in the first year after rescheduling, a decline of nearly 21 percent.

“It appears that up-scheduling of hydrocodone accomplished the goal of the DEA,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and author of The Painful Truth. “The more important question is what impact this has had on the rate of abuse and patient access to the medication. It may be too early to know whether rescheduling has affected the rate of people abusing opioids or if it just forced some abusers to seek alternatives like heroin.

“The JAMA report suggests that even cancer patients found it more difficult to obtain hydrocodone. That should be alarming to the medical community and illustrate to policy makers and law enforcement there are consequences to every action and in this case some people have been subjected to more cost, inconveniences and abandonment without any data to suggest an improvement in abuse or overdoses.”

Interestingly, the number of hydrocodone prescriptions written by pain management specialists after rescheduling increased by 7 percent. And there was a modest 4.9% increase in the number of prescriptions for opioids other than hydrocodone, as some patients apparently switched to opioids that were easier to obtain.

"The uptick from pain specialists most likely reflects a transfer of narcotic provision from non-specialists to specialists. That is, a decrease in prescribing from those who have less training in prescribing opioid pain relievers offset to some extent by an increase from those who have more such training," said Stuart Gitlow, MD, Executive Director of the Annenberg Physician Training Program in Addictive Disease and past president of the American Society of Addiction Medicine.

Gitlow believes the large overall decline in hydrocodone prescribing was a sign that many of the refills being ordered before rescheduling "were ultimately determined to be unnecessary."

"This was not meant to address the overall opioid prescribing problem, but was rather filling one hole in the dike," Gitlow wrote in an email to Pain News Network. "There remains much left to do, such as removal of the cap for treatment of opioid use disorders in office settings, and availability of tapering to avoid having patients move to heroin when their supply of prescription narcotics is suddenly cut off."

Hydrocodone was once the most widely prescribed medication in the United States, with over 137 million prescriptions annually. Prescribing of hydrocodone was already in decline before rescheduling, because of growing concern the drug was being abused and diverted.