Tell the FDA There is an Urgent Need for New Options for Pain – DEADLINE TODAY


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TODAY IS THE DEADLINE


Electronic comments can be submitted here. Again, the deadline is Monday at 11:59 PM EST.

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Your comment doesn’t have to be long to make a difference.

Tell the FDA There is an Urgent Need for New Options for Pain

 

from

Cindy Steinberg, National Director of Policy & Advocacy,

US Pain Foundation

 

 

At the U.S. Pain Foundation, we often send out notifications to the pain community about opportunities to take action on pain-related issues at the federal level. Most people, if they are anything like me before I became an advocate, assume weighing in on these opportunities doesn’t make a difference.

 

I want you to know that it does! Your voice really does matter. Federal agencies have rules for how they must handle responses to public comment periods. They are required to review and consider public comments in their final rulemaking. Typically, comments are read and then categorized according to key topics or concerns within the comments. If 1,000 people write in about a key topic or concern, it gets attention. At the very least, a large response to a comment period lets the agency know that many people are paying attention to what they are doing and will want to see their views reflected in the final product.

 

With that in mind, I want to encourage all people with pain to submit their comments about the urgent need for new medication options for pain relief to the Food and Drug Administration (FDA) by this Monday, Nov. 18, at 11:59 pm EST. Specifically, the FDA would like the public’s views on two main issues:

 

  1. Should sponsors of new opioids be required to demonstrate comparative advantage relative to existing opioids?

  2. What incentives would better support and encourage the development of new treatments for pain?

This comment opportunity comes on the heels of a Sept. 17 public hearing at the FDA, called “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” At this hearing, many different views on these questions from various individuals and organizations were presented. For example, some people said that no new opioids should be approved and that existing opioids should be reconsidered for possible removal. Others said that there has been a drought of innovation in pain therapeutics and that FDA should do more to encourage innovation.

 

Sadly, it is true that there has long been a dearth of new safe, effective medications approved for pain. We encourage you to tell FDA what impact pain has had on your life and how speeding up the development of new drugs in the pipeline could make a difference to your life and the lives of so many others debilitated by chronic pain.

 

Electronic comments can be submitted here. Again, the deadline is Monday at 11:59 PM EST.

 

Your comment doesn’t have to be long to make a difference. What’s most important is that you submit one. This is one way that you can contribute to a better future for people with pain.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~~~~

For My Home Page, click here:  

Welcome to my Weblog on Pain Management!

 

Please ignore the ads below. They are not from me.

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THE ADVERTISING BELOW IS NOT FROM ME.

Low Dose Naltrexone for Pain


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From NPR: 

In Tiny Doses, An Addiction Medication Moonlights As A Treatment For Chronic Pain

 

Alex Smith

 

Lori Pinkley, a 50-year-old from Kansas City, Mo., has struggled with puzzling chronic pain since she was 15.

 

She’s had endless disappointing visits with doctors. Some said they couldn’t help her. Others diagnosed her with everything from fibromyalgia to lipedema to the rare Ehlers-Danlos syndrome.

 

Pinkley has taken opioids a few times after surgeries but says they never helped her underlying pain.

 

“I hate opioids with a passion,” Pinkley says. “An absolute passion.”

 

Recently, she joined a growing group of patients using an outside-the-box remedy: naltrexone. It is usually used to treat addiction, in a pill form for alcohol and as a pill or a monthly shot for opioids.

 

As the medical establishment tries to do a huge U-turn after two disastrous decades of pushing long-term opioid use for chronic pain, scientists have been struggling to develop safe, effective alternatives.

 

When naltrexone is used to treat addiction in pill form, it’s prescribed at 50 mg, but chronic-pain patients say it helps their pain at doses of less than a tenth of that.

 

Low-dose naltrexone has lurked for years on the fringes of medicine, but its zealous advocates worry that it may be stuck there. Naltrexone, which can be produced generically, is not even manufactured at the low doses that seem to be best for pain patients.

 

Instead, patients go to compounding pharmacies or resort to DIY methods — YouTube videos and online support groups show people how to turn 50 mg pills into a low liquid dose.

 

Some doctors prescribe it off-label even though it’s not FDA-approved for pain.

 

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For discussion of mechanism and case reports of the remarkable efficacy of this anti-inflammatory medication, use search function top left above small photo. Thankfully his insurer is covering the cost of the compounded capsules.

 
 
 
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The material on this site is for informational purposes only.

.
It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~~~~

For My Home Page, click here:  

Welcome to my Weblog on Pain Management!

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Opioid Intimidation – 29% Decline in Doctors Prescribing by 2017


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The New England Journal of Medicine published a report from Harvard researchers on March 14, 2019, entitled

Initial Opioid Prescriptions among U.S. Commercially Insured Patients, 2012–2017.

They found a “29% reduction in the number of providers who initiated opioid therapy in any patient who had not used opioids, from 114,043 in July 2012 to 80,462 in December 2017.”

Two of my own physicians, both distinguished, outstanding – an internist and a specialty cardiologist who does painful procedures – have said they will never prescribe opioids again. If I ever need an opioid for pain, it is possible I may never be able to get a prescription.

One of my pain management colleagues has defended 6 colleagues in the last 6 months before the Medical Board.

This is just the beginning of Opioid Intimidation perpetuated by government and CDC. It is deeply worrisome and it is getting worse.

We have a shortage of pain management specialists and those that have survived mostly do procedures, delegating prescription writing to PA’s and NP’s because it is time consuming and does not pay. There is a formidable barrier of denials by insurers for nonopioid medications, physical therapy, acupuncture, yoga, Pilates, cognitive behavioral therapy, and all compounded medications. Denials have become voluminous for at least 10 years. The process is not only time consuming, it is expensive, it wears us all down, inflicts horrific cruelty on patients, and to top it all off the appeals system is a joke.

Who would want to go into the pain management field ever again?

Stay tuned for more stories to come.

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The material on this site is for informational purposes only.

.
It is not legal for me to provide medical advice without an examination.

.
It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~~~~

For My Home Page, click here:  

Welcome to my Weblog on Pain Management!

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CMS Criteria Do Not Accurately Identify Patients at Risk for Opioid Use Disorder, Overdose


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CMS criteria do not accurately identify patients at risk for opioid use disorder, overdose

Wei Y, et al. JAMA. 2019;doi:10.1001/jama.2018.20404.

February 15, 2019

 

The CMS opioid overutilization criteria may not accurately identify patients at risk for opioid use disorder or overdose, according to a research letter published in JAMA.

“Based on the CMS opioid overutilization criteria, the majority of the Medicare Part D patients diagnosed with opioid use disorder or overdose were not identified as ‘opioid overutilizers,’ and more than half of ‘opioid overutilizers’ did not develop opioid use disorder or overdose during the study period,” Yu-Jung Jenny Wei, PhD, Msc, assistant professor of pharmaceutical outcomes and policy at the College of Pharmacy, University of Florida, told Healio Primary Care Today. “The CMS criteria seem not to be a good clinical marker for identifying patients at risk for opioid-related adverse events.”

To estimate the predictive value of the CMS opioid overutilization criteria in correctly identifying prescription opioid users at risk for opioid use disorder or overdose, researchers used the 5% Medicare sample from 2011 through 2014 from which they identified between 142,036 and 190,320 beneficiaries who had at least one opioid prescription filled every 6 months, were continuously enrolled in Parts A, B and D and who met the CMS criteria as opioid overutilizers. Opioid utilization was defined as receiving prescription opioids with a mean daily morphine equivalent dose 90 mg from more than three prescribers and pharmacists or receiving a mean daily morphine equivalent dose of 90 mg by more than four prescribers.

Breaking the study period into three 6-month cycles, researchers examined the performance measures over time to assess if accuracy changed with increasing efforts to combat the opioid crisis. 

During any 6-month cycle, the proportion of beneficiaries who met CMS overutilization criteria ranged from 0.37% to 0.58%.

Throughout the entire 18-month follow-up, researchers found that the proportion of patients who had a diagnosis of opioid use disorder or overdose increased from 3.91% in the first cycle to 7.55% in the last.

In addition, researchers observed low sensitivity of the criteria which ranged from 4.96% (95% CI, 4.42-5.58) at the beginning of the study period to 2.52% (95% CI, 2.26-2.81) at the end (< .001).

 The CMS opioid overutilization criteria may not accurately identify patients at risk for opioid use disorder or overdose.Source: Adobe Stock

Positive predictive values ranged from 35.2% (95% CI, 32.14-38.38) to 50.95% (95% CI, 47-54.86) and specificity was greater than 99% in all cycles. 

“CMS has required their Medicare Part D plans to implement the criteria,” Wei said. “It’s unclear the effectiveness of such criteria in stopping our national opioid epidemic and whether there are unintended consequences of such implementation. As we are developing solutions to the opioid crisis, it’s important for policymakers, health care providers, hospitals and health insurance companies to be aware that solely relying on opioid prescription data is likely to be ineffective in identifying the high-risk populations for interventions.” – by Melissa J. Webb

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Revision in CDC Opioid Guidelines Demanded


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Revision in CDC Opioid Guidelines Demanded

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  • by Shannon Firth, Washington Correspondent, MedPage Today February 15, 2019 

WASHINGTON — Pain patients tell Congress the CDC’s opioid guidelines are hindering access to vital medications, and an FDA panel recommends approval of esketamine for treatment-resistant depression.

Pain Patients to Congress: CDC’s Opioid Guideline Is Hurting Us

Patients with chronic pain are suffering from ham-handed efforts to curb opioid overdoses, a series of witnesses told the Senate Health, Education, Labor and Pensions (HELP) Committee on Tuesday.

In particular, the CDC’s 2016 guidelines for opioid prescribing came under heavy fire, as even a self-described supporter of its recommendations admitted the evidence base was weak.

Cindy Steinberg, national director of policy and advocacy for the U.S. Pain Foundation, argued that well-intentioned efforts to address the epidemic — particularly strategies to tamp down overprescribing — have stoked a “climate of fear” among doctors.

Thousands of patients with chronic pain have been forcibly tapered off their medications or dropped from care by their physicians, said Steinberg. (Physicians in California, under threat of medical-board sanction if patients die from overdoses, have reported similar reactions.)

Such decisions are “inhumane and morally reprehensible,” she said.

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The material on this site is for informational purposes only.

.
It is not legal for me to provide medical advice without an examination.

.
It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Pain Patients to Congress: CDC’s Opioid Guideline Is Hurting Us, 2% NIH budget for Pain


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Pain Patients to Congress: CDC’s Opioid Guidelines is Hurting Us. Has stoked “climate of fear” leading to inadequate treatment of chronic pain

CLIMATE OF FEAR

WASHINGTON — Patients with chronic pain are suffering from ham-handed efforts to curb opioid overdoses, a series of witnesses told the Senate Health, Education, Labor and Pensions (HELP) Committee on Tuesday.

  • by Shannon Firth, Washington Correspondent, MedPage Today February 13, 2019 

In particular, the CDC’s 2016 guidelines for opioid prescribing came under heavy fire, as even a self-described supporter of its recommendations admitted the evidence base was weak.

In 2018, Congress passed the SUPPORT for Patients and Communities Act, which included billions of dollars in funding aimed at curbing the overdose epidemic and expanding access to treatment for those with substance use disorders.

About 50 million Americans suffer from chronic pain and almost 20 million have high-impact chronic pain. At the same time, more than 70,000 people died from drug overdoses in 2018, often involving opioids, said HELP Committee Chairman Lamar Alexander (R-Tenn.) at the start of Monday’s hearing.

Even as Congress tries to dramatically curb the supply and the use of opioids, “we want to make sure … that we keep in mind those people who are hurting,” said Alexander.

Cindy Steinberg, national director of policy and advocacy for the U.S. Pain Foundation, argued that well-intentioned efforts to address the epidemic — particularly strategies to tamp down overprescribing — have stoked a “climate of fear” among doctors.

Thousands of patients with chronic pain have been forcibly tapered off their medications or dropped from care by their physicians, said Steinberg. (Physicians in California, under threat of medical-board sanction if patients die from overdoses, have reported similar reactions.)

Such decisions are “inhumane and morally reprehensible,” she said.

Steinberg, herself a pain patient, said she takes opioids in order to function. Eighteen years ago, Steinberg was injured when a set of cabinets fell on her. Since her accident, she experiences constant pain, she said, and throughout the hearing she took breaks from testifying to recline on a cot and pillow.

She was especially critical of the CDC’s opioid guidelines, which included recommendations regarding the number of days and dosage limits for certain pain patients.

“When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed,” notes a CDC fact sheet.

These recommendations have been “taken as law,” she said.

In 2016, Massachusetts set a 7-day limit on first-time opioid prescriptions, according to the National Conference of State Legislatures, which counted 33 states with laws limiting opioid scripts as of October 2018.

Steinberg said the guidelines should be rewritten.

Because of the CDC’s reputation, “people think that those [guidelines] are based on strong science and they’re not,” Steinberg said. Pain consultants were not involved in the development of the guidelines, she said.

(Voicing similar concerns in November, the American Medical Association passed a resolution opposing blanket limits on the amount and dosage of opioids that physicians can prescribe.)

Steinberg pointed instead to the Pain Management Best Practices Inter-Agency Task Force, a group appointed by Congress of which she is a member, which issued its own draft recommendations in December.

Alternatively, the NIH (which she noted has an office dedicated to pain policy) could be asked to make recommendations, she suggested.

Halena Gazelka, MD, chair of the Mayo Clinic Opioid Stewardship Program in Rochester, Minnesota, pointed out that the guidelines were “intended to advise primary care providers” and not to provide “hard and fast rules.”

“I actually like the CDC guidelines,” Gazelka said. Mayo’s own guidelines are based on the CDC’s. However, “the doses that are mentioned, probably are not scientifically-based, as we would prefer that they would be,” she acknowledged.

Another challenge for some pain patients are situations that pit prescribers against pharmacists, said Sen. Lisa Murkowski (R-Alaska).

“It’s the pharmacists that are refusing to fill the prescription the doctor has prescribed,” she said, blaming the CDC guidance. Pharmacists are following it out of “an abundance of caution,” including in cases where abuse is not suspected, she suggested.

Steinberg said, “I think we need public education about pain and the fact that pain is a disease itself. … Pharmacists are not getting proper training in that, I don’t think anyone is getting proper training in pain.” She asserted that veterinarians get nearly 10 times as many hours of pain management training as do medical students.

Andrew Coop, PhD, of the University of Maryland School of Pharmacy in Baltimore, returned to the CDC guideline. “I think those guidances on the quotas, I think they’ve been taken too far and that needs to be rolled back.”

Improving Care

In exploring other ways to improve care for patients with chronic pain, Gazelka recalled the pain clinics that existed 30 years ago, which included a physician, a psychologist, and a physical therapist.

“It would be ideal to return to a situation where people could have all of that care in one place,” Gazelka told MedPage Today after the hearing. But most small practices and even institutions may not have the same blend of clinicians, and the cost could be “prohibitive,” she said.

Access to specialists also poses a problem, noted witnesses as well as senators.

In her own pain group, it takes patients more than a year to get an appointment with pain specialists, Steinberg said. She encouraged Congress to “incentivize” pain management as a specialty.

Gazelka agreed and suggested leveraging telemedicine and electronic health records to extend the reach of existing specialists.

Telemedicine can allow primary care physicians to consult with pain management specialists, she said. Also, in Mayo’s own controlled substances advisory group, she and other specialists review cases submitted by primary care clinicians and provide advice directly into the patient’s medical record. However, Gazelka noted that privacy protections in some states might disallow that.

Gazelka noted that insurance coverage can be a barrier to non-opioid alternatives. For example, the Mayo Clinic has a Pain Rehabilitation Center staffed by specialists in pain medicine, physical therapy, occupational therapy, biofeedback, and nursing that aims to treat pain without opioids. But Medicaid won’t pay for it, she testified.

Witnesses also spoke of efforts to develop non-addictive painkillers, such as NIH’s Helping to End Addiction Long-term program.

Steinberg called these efforts “a great start” but noted that only 2% of the NIH’s budget is directed towards pain research. Funding should be “commensurate with the burden of pain,” she said.

Finally, Coop pressed the committee to take seriously the potential of medical marijuana.

Acknowledging that it’s a controversial area, he stressed the need for “good consistent, well-designed clinical studies with good consistent material,” referring to the type of marijuana used.

But speaking to reporters after the hearing, Alexander was cautious. “I’ve supported giving states the right to make decisions about medical marijuana. That’s about as far as I’m willing to go right now.”

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The material on this site is for informational purposes only.
.
It is not legal for me to provide medical advice without an examination.

.
It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please ignore the ads below. They are not from me.

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CBD Anti-inflammatory, does not make you “high”


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CBD from CV SCIENCES Las Vegas, NV, is top rated by Consumer Labs. They sell CBD spray, oil, capsules, and softgels. The soft gels contain 5mg of hemp-derived CBDA/CBD oil per serving that includes terpenes, phytocannabinoids, fatty acids. Capsules contain 10 or 15 mg CBD are “made using our Total Plant Complex” that includes terpenes, phytocannabinoids, plant sterols, fatty acids.

One patient says the softgel is small, easy to swallow. “PlusCBD Oil Raw Softgels offer the fullest spectrum of naturally occurring hemp co-factors and contain 5mg of hemp-derived CBDA/CBD oil per serving.” [6.2 mg consumers labs say, tho bottle says 10 mg]

CWHemp in Boulder, CO, sells CBD oil and capsules. One patient who had 3 different pain conditions, each one disabling, severe, found it far better than CBD tried in 3 different states.

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One patient, A, has several conditions responding to CBD, discussed below.

TINNITUS:

She has suffered many years of tinnitus.

Soon after starting CBD, the tinnitus is now down to where she is just barely able to hear it. “It was driving me crazy: clicking, grinding, hissing, whiny, scraping like pieces of sandpaper being scraped together. I thought I’m going to go crazy. Now I can barely hear a hiss at all on left, and on the right very very low hardly discernible hiss. It’s like a miracle.”  Taking 1 twice daily, maybe have been taking them for 2 weeks, it’s amazing to me.”

Pains are 80% better:

Stiffness in hands, osteoarthritis arthritis pain in knuckles

 
70% relief left shoulder had been barely able to pick up the shoulder due to bone on bone osteoarthritis. Not frozen shoulder but the pain mimicked frozen shoulder, pseudo-frozen. Markedly better.


Anxiety:

Lifelong anxiety disorder has been helped to a degree, allowed drop in Xanax down to 3.0 mg/day from 3.5 mg total daily dose of Xanax she was taking since 1990. And dropped dose within the first week on 12 mg CBD dose, able to leave out the 2 pm Xanax. 


Had been using 2  of the 12 mg capsules from Leafly initially.


Vertigo due to BPPV, very severe:

25% improved, can roll over in bed now without feeling like flying off the bed. Helped balance related to the vertigo. The tinnitus had made the vertigo worse, so lessening of tinnitus has lessened the vertigo. Helped the balance, not a lot, but since vertigo is diminished, balance is better. 


“THC gives me more trouble than the CBD because I know I am not going to have a paranoid attack on CBD.  I’ve now lost my desire to smoke marijuana for relief. There is no change yet in depression, but during SAD [Seasonal Affective Disorder] and weeks of grey weather, I can’t tell.”

BAM, the devastating bile acid malabsorption:

No change yet. I have been manipulating diet to get results I need, now fairly good control by taking more water. Not having the horrible bile burn in lower abdomen, none in days. I’m not sure why yet. Water intake, I can’t even tell because I’m so sporadic. If I could get into me minimum 4 full glasses a day, I probably could control the constipation part. I’d rather deal with that than the diarrhea which is debilitating.” 

Ear Pressure:

JG no longer needs to be taking ibuprofen to treat PRESSURE in ear. It felt like the tubes were full of fluid and that pressure from the tubes was having a vacuum type effect on the eardrum itself.  He’s been to every ENT at Rush Memorial, next will see ENT at Loyola. It was distracting and uncomfortable, made him miserable, frustrated and did not want to take the medication because he was concerned about NSAID adverse effect on the heart. Was taking Ibuprofen every few hours, now no longer needed. This pressure has been disabling for years.

 
He is taking CBD 12mg/day, now will start taking 18-19 mg.
This is profound. 

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The material on this site is for informational purposes only.
.
It is not legal for me to provide medical advice without an examination.

.
It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please ignore the ads below. They are not from me.

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