The F.D.A. declined to issue a ban on Depo-Medrol, like Australia, Brazil, Canada, France, Italy, New Zealand and Switzerland

Above blog post addresses how the FDA declined to ban Depo-Medrol being used is ESI procedures unlike many other countries have done.

Now that the Democrats have taken over control of the House, is it time to start planning on talking with them – face to face – about what they proposed on doing that will/should have a positive impact on the chronic pain community ?

Each member of Congress in back in their district multiple times a year and often have one or more days set aside to meet with constituents. Many will make an appointment for a 15 minutes one to one… face to face meeting.

Here are a few things that they have been backing:

# “Medicare for all”… does this suggest that all disease/health issues should receive appropriate care (standard of care & best practices)  ?

# coverage of preexisting health issues .. does this mean that the number of medication on a formularies should not be cut down year after year

# Fraud and abuse of Medicare/Medicaid… does this mean that products and services should not provided/paid for when there is a lack of medical necessity or when the service/procedure is discouraged by the FDA and/or medication manufacturer . There is an estimated 10 million ESI’s each year (estimate cost $ 10 -30 Billion) and it is estimated that 5% will end up with https://en.wikipedia.org/wiki/Arachnoiditis     reportedly a very painful disease and irreversible disease caused by a medical error and/or procedural mistake.  Annual cost to treat unknown.

Prohibit prescribers from mandating a pt to received a ESI procedure in order to receive oral opiates… this is an inducement/incentive to cause Medicare/Medicaid to expend dollars . DEA is charging prescribers with Medicare/Medicaid fraud when the prescriber is being charged with prescribing opiates/controlled substances without valid medical necessity.

When meeting with a member of Congress… create a packet of information… first page should be just “bullet points” on a two or three issues and other parts of the packet should be more detailed information related to the bullet points on the first page.  Take several copies of all material with you.

Session is now GONE… three more states have legalized Marijuana… Congress is spending nearly ONE TRILLION/yr than we take in.  New Congressional session starts in Jan

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Washington prison inmate awarded $549,000 after he’s denied pain medication for multiple sclerosis

https://www.seattletimes.com/seattle-news/washington-prison-inmate-awarded-550000-after-hes-denied-pain-medication-for-multiple-sclerosis/

A federal jury found that three prison medical staffers showed “deliberate indifference” to Etienne Choquette’s pain and medical needs when they refused to allow him medication that was prescribed to him by a neurologist.

A Washington state inmate with multiple sclerosis who was four times denied nonaddictive nerve-pain medication by prison staff has been awarded  $549,000 by a federal jury in Tacoma.

The jury last week found that three prison medical staffers showed “deliberate indifference” to Etienne Choquette’s pain and medical needs when they refused to allow him medication that was prescribed to him by a neurologist.

Choquette was awarded $149,000 in compensatory damages for violation of his Eighth Amendment rights and $400,000 in punitive damages.

“The jury sent a strong message to the DOC (Department of Corrections) and its officials that they must treat the prisoners under their care with basic human dignity,” said Jesse Wing, one of Choquette’s attorneys.

“The defendants repeatedly denied our client a simple, generic medication for almost five months when they knew their decisions would cause him terrible nerve pain. These state officials thought no one would care. But the jury did, and it found their behavior cruel, in violation of the Bill of Rights,” Wing said.

The state Attorney General’s Office, which defended the three prison officials, deferred comments to Department of Corrections spokesman Jeremy Barclay who said the department is still “reviewing and assessing the ruling.”

Choquette, 54, had been diagnosed with multiple sclerosis in 2009 and given a prescription for gabapentin before he was imprisoned  in 2011  for the murder of a Forks man that Choquette believed was physically abusing a female friend.

While in custody at the Washington State Penitentiary in Walla Walla in November 2013, Choquette was seen by a neurologist who recommended that Choquette’s dosage of gabapentin be increased from 2,400 milligrams to 3,600 milligrams per day to address increased pain, according to court documents filed in U.S. District Court.

Gabapentin is a non-opioid prescription medication used to control seizures, but also commonly prescribed to address neuropathic pain, the suit claimed. It is not classified as a controlled substance by the Drug Enforcement Agency.

Because the higher amount of medicine was above the typical standard dose used by Department of Corrections medical staff, Choquette’s primary health-care provider submitted a special “non formulary request” seeking approval of the medication, according to the lawsuit.

The request was denied by prison pharmacist Cris DuVall, who instead recommended that Choquette be taken off gabapentin and treated instead with extra clinical observation and an increase of another one of Choquette’s medications.

Both DuVall and the Department of Corrections’ chief medical officer, Dr. G. Steven Hammond, “explained that they did not understand why gabapentin would be used in this context,” the lawsuit claimed.

But Choquette’s pain did not abate, according to the lawsuit.

His primary medical provider again submitted a request for the increased gabapentin prescription about a month later, explaining that withdrawal off the drug had negative effects.

But the request was denied again, this time by pharmacist Michelle Southern, who mistakenly determined that the only use for gabapentin among MS patients was for treatment of an eye condition, the suit claimed.

Southern suggested that Choquette’s provider refer the case to the department’s Care Review Committee (CRC), which is supposed to review nonstandard requests to determine if they are medically necessary.

The board determined that gabapentin was not medically necessary,  but also decided to send Choquette to a specialist in Seattle.

He was transferred to the Monroe Correctional Complex and eventually saw the second specialist, a neurologist with expertise in treating MS, who agreed with the recommendation of the first neurologist seen by Choquette months earlier, according to the suit.

On April 23, 2014, Choquette’s doctor at Monroe presented the patient’s case once again to the CRC, which again determined gabapentin was not medically necessary.

When informed about the board’s decision, the second neurologist wrote that she “had no doubt the plaintiff was in pain, that there was no ‘objective’ test to prove his pain, and that gabapentin was the standard, first-line drug for neuropathic pain in MS patients,” the suit claims.

At the end of April, the case was presented again to the board, which finally determined that the gabapentin was medically necessary.

To prove that Choquette’s Eighth Amendment rights had been violated, his attorneys had to convince jurors that the inadequate medical care he received was the result of deliberate indifference by prison officials to a serious medical need.

In the suit, Choquette alleged that the defendants were aware of his diagnoses, his neuropathic pain, and that he had previously been on gabapentin for that pain, and yet still withheld the medication for over four months.

Further, he alleged that the Department of Corrections officials relied on the judgment and opinions of non-treating and nonspecialist medical personnel over the opinion of the medical staff and specialist who were treating him.

Jurors assessed $200,000 in punitive damages to Hammond, $175,000 to DuVall and $25,000 to Southern.

Barclay declined to give the salaries of the three defendants, but said two of the three had resigned from their DOC positions in 2014, and the remaining staff member retired in 2017 but was brought back as a non-permanent employee in 2018.

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After Doctors Cut Their Opioids, Patients Turn to a Risky Treatment for Back Pain

www.nytimes.com/2018/07/31/health/opioids-spinal-injections.html

Image

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FDA approves painkiller 10 times stronger than fentanyl; UK doctor and other advisors objected

https://www.nkytribune.com/2018/11/fda-approves-painkiller-10-times-stronger-than-fentanyl-uk-doctor-and-other-advisors-objected/

The Food and Drug Administration approved a powerful new painkiller Friday over the objections of a Kentucky doctor who co-chairs its advisory committee on such matters, and other physicians.

Dr. Raeford Brown of the University of Kentucky and others argue that sufentanil, 10 times more powerful than fentanyl, “would inevitably be diverted to illicit use and cause more overdose deaths,” reports Lenny Bernstein of The Washington Post.
Brown, a professor of anesthesiology and pediatrics, is the longtime chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. The panel voted 10-3 on Oct. 12 to support approval of the drug, which was developed with millions of dollars from the Pentagon, which wants an easier-to-use painkiller for the battlefield.

The drug, branded as Dsuvia, is “a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator,” reports Ed Silverman of Stat. That makes it “well-suited for the military and therefore was a priority for the Pentagon, a point that factored heavily into the decision,” according to FDA Commissioner Scott Gottlieb.

Dr. Raeford Brown

“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain”

” Gottlieb wrote in what the Post called “an unusual statement, saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market. That might allow the agency to turn down future applications for new opioid approvals if the drugs are not filling an unmet need.”

Gottlieb’s words did not satisfy Brown and the advocacy group Public Citizen, who said in a statement that AcelRx, the manufacturer, had not proven the pill’s effectiveness or adequately responded to safety concerns. They noted that the FDA did not convene its Drug Safety and Risk Management Advisory Committee to consider the application.

“Clearly, the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown said. “I will continue to hold the agency accountable for their response to the worst public-health problem since the 1918 influenza epidemic.”

Dr. Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University and is executive director of Physicians for Responsible Opioid Prescribing, an education and advocacy group, told Stat, “There is absolutely no need for this product. Claiming we need it on the market to help soldiers on the battlefield is ridiculous,” because fentanyl administered under the tongue is available for battlefield use.

Gottlieb said, “There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.”

The Post reports, “The FDA says that controls on drugs inside medical facilities are tight and the greatest risk of diversion is among medical personnel themselves. A 2016 survey conducted by the federal Substance Abuse and Mental Health Services Administration shows that narcotics are rarely stolen from doctor’s offices, clinics, hospitals or pharmacies. Fewer than 1 percent of people said they acquired opioids that way.”

The rate of overdose deaths among health care workers is relatively high, however, according to an August study by the Centers for Disease Control and Prevention, with 876 succumbing to prescription opioids between 2007 and 2012.

Sufentanil is “commonly used after surgery and in emergency rooms,” the Post notes. The Dsuvia pills “would not be available in retail pharmacies” and would carry a wholesale price of $50 to $60 per dose. “A spokeswoman said the company is not providing information on expected sales.”

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I-Team: Opioid crisis: Crackdown fails to cut opioid overdoses; deaths on the rise

https://www.lasvegasnow.com/news/local-news/i-team-opioid-crisis-crackdown-fails-to-cut-opioid-overdoses-deaths-on-the-rise/1575669160

LAS VEGAS – A year ago this month, 8 News Now aired a multi-part, in-depth project called “#OurPain: The other side of opioids,” which explored the mostly untold stories of how a crackdown on prescription medications has affected millions of legitimate patients dealing with chronic pain.

#OurPain: Opioid crisis leaves legitimate pain patients struggling

The Centers for Disease Control started this ball rolling back in 2016 when it issued supposedly voluntary guidelines that have since been enacted into law across the country.  In the past 12 months, the crackdown has intensified, though it failed to put a dent in opioid overdoses. 

I-Team: Feds ask public for help with opioid crisis

Barby Ingle, the president of the International Pain Foundation, learned about chronic pain patients the hard way when she became one. Ingle lost everything to pain, then slowly rebuilt her life and became an advocate for pain patients. 

Since  2016, when the CDC initiated the great opioid crackdown by issuing supposedly voluntary guidelines, the suffering of millions of legitimate pain patients grew to be worse. 

“I’m hearing more desperation,” Ingle said.  “I’m hearing about more suicides, more loss of friends.”

Ingle says she hears the stories every day through her pain foundation, but now, the news is slowly seeping out.  

Suicides among pain patients, including veterans and seniors, have spiked.  Pain patients who could function and hold jobs have had to leave the workforce after being cut off. 

Forced reductions in the production of opioid medications is felt in hospital emergency rooms, even in hospices where end-of-life cancer patients have had to suffer.  

The crackdown on pain medications not only failed to cut opioid overdoses, but the deaths have also gone up.  Especially, in areas that cut down the most.  Death records, including in Nevada show that 80 percent of deaths are from illicit drugs like heroin and fentanyl, or a combination of drugs and alcohol, along with other underlying medical problems.

“Gunshot wounds; people who are taking multiple medications or mixing medications, even NSAIDs and opioids, It could have been the NSAIDs that gave you internal bleeding, but they blame it on opioids only,” Ingle said.

The annual pain week symposium held in Las Vegas was missing many familiar faces this year.  Pain doctors are shutting down their practices out of fear they will be prosecuted.  

Pain pioneer Dr. Forrest Tennant earned a lifetime achievement award one year ago. Now, his practice is shut down. Not because he was charged with any crime, but merely because he was served a search warrant. That kind of news spreads fast among doctors.

“We already know patients are having trouble finding doctors willing to treat them, especially in rural areas — pain management doctors are extremely hard to find,” said Pat Anson, Pain News Network.  “And if they are abandoning their practice and doing whatever they can do safely, who is going to treat the pain patient of the future from the standpoint of the patient, they are being abandoned.  From the standpoint of the doctor, they could be going to jail if they don’t stop prescribing, o what choice do they have?”

Since January when a new state law kicked in, Nevada doctors have sought clarification from the medical board about what the crackdown means here. At its most recent meeting, the board approved general guidelines that are far less Draconian than in other states, but the required paperwork is burdensome, and patients are being cut back regardless of their individual medical needs.

“I had my pain management physician involuntary taper me down to 90 MMEs and their entire amount of patient; they had like 300 patients and told me they were going to taper all of them down to 90. We’re all in pain because of it,” said Rick Martin, patient advocate.

Martin says the worst may come in January when new federal guidelines give pharmacies and insurance providers more power to overrule no matter what a doctor might prescribe,

“The insurance company is basically got a prescription pad and a white coat now, telling the legislators and doctors what to do,” Martin said. “The patient-doctor relationship is shattered.”

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Notice NOT ONE REPUBLICAN signed this letter. It was also the Democrats that voted AGAINST Medicare Part D in 2004-2005.  When Medicare started in 1965 there was no medication coverage

Part A covered hospital

Part B  covered doc’s office visits and lab tests

Once a pt got a diagnose with what their health issues where.. there was no coverage for medication to treat their health issues.

Off course, back then, the average Rx price was abt $4 and there were few generics.. everything was BRAND NAME…

Today with generics being some 85%+ of all prescriptions the average Rx price is pushing $60 each.

We really didn’t start see price increases until the PBM’s came to being (1969-1970)  with the goal of saving the pts and the system money and when Congress starting pushing for generics to come to the market place.. mid-70’s.

If one applied the CPI (Consumer Price Index) or COLA ( Cost of Living Index Adjustment) to those 1965 prices… and nothing else changed one would expect that the average Rx price to be in the $ 30 -40 range today.

Aren’t we all glad that the increase in generic utilization and the PBM industry has helped us all save money ?

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Cocaine Back in a Big Way, DEA Warns, with Rising Overdose Deaths

https://pjmedia.com/news-and-politics/cocaine-back-in-a-big-way-dea-warns-with-rising-overdose-deaths/

I wonder what they are going to blame on for this surge in Cocaine use/abuse… what is the “gateway drug”..it is not a normally used prescription medication.

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‘El Chapo’ Goes On Trial This Week But His Billion Dollar Drug Empire Continues Under his Sons, Judge Says

https://www.newsweek.com/el-chapo-goes-trial-week-his-billion-dollar-drug-empire-continues-flourish-1200601

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TBI: counterfeit drugs are newest trend contributing to opioid epidemic

https://www.wjhl.com/top-news/regional/tbi-counterfeit-drugs-are-newest-trend-contributing-to-opioid-epidemic/1570683855

KNOXVILLE (WATE) – The Tennessee Bureau of Investigation is reporting a new trend contributing to the opioid epidemic: counterfeit drugs. 

The phenomenon involves drugs, specifically pills, made to look like prescription medications like Percocet or Xanax.

Using pill presses that can produce thousands of pills in an hour, the medications are manufactured to look real, but are made with a combination of other drugs. 

“Pharmaceutical manufacturers will tell you, when you take powders and try to mix them together, it’s one of the most difficult things that they do,” said T.J. Jordan, Assistant Director for the TBI, overseeing the drug division. 

Jordan says the growing trend is dangerous because the counterfeit drugs can be laced with more deadly combinations, like fentanyl, without the buyer knowing. One could talk to Renaissance Recovery de-addiction experts to get help with overcoming the issues.

The counterfeit pills are more increasingly sold online using the “Darkweb,” according to the TBI’s annual report, and cannot usually be traced as easily by law enforcement. 

“People think they’re buying hydrocodone, but they’re actually getting a pill laced with fentanyl. They think they’re getting a good pill, but actually, it’s counterfeit and it isn’t what it appears to be,” said Jordan. 

In Knoxville, a local pharmacist says his job changes weekly to stay up-to-date to new medications and prescription laws. 

 “I understand that people want to save money, i understand that money can be tight, but it’s not worth risking your life over saving $5 on the internet getting a medication that you may not know what you’re getting,” said Matt Windham, pharmacist in charge at Belew Drugs on Washington Pike in Knoxville. 

Windham says while he doesn’t think about counterfeit drugs everyday, he hopes to educate the community about the risks associated with some drugs, to help the community be safer. 

The TBI reports investigations involving counterfeit drugs are increasing statewide. 

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Chronic Pain in Adults on the Rise: A Potential Crisis

https://www.medscape.org/viewarticle/904084

Clinical Context

All clinicians are aware of the mandate to reduce opioid use, but is awareness having an effect? Data from the Centers for Disease Control and Prevention suggest that the tide has shifted in the prescription rate for opioids.^[1] Opioid prescription rates reached a peak in 2010 to 2012, but since then, there has been a steady decline. In 2012, the rate of opioid prescriptions per 100 persons in the United States was a staggering 81.3. That figure fell to 58.5 by 2017. Prescription rates for high-dose opioids have fallen by more than half from their peak in 2008.

Nonetheless, 17% of Americans received at least 1 opioid prescription in 2017, and these patients averaged 3.4 prescriptions over the year. There is wide geographic variability in the rate of opioid prescriptions, with rates generally higher in locations with larger proportions of non-Hispanic white residents and more primary care physicians and dentists.

While US healthcare practitioners grapple with the opioid epidemic, we still need to treat the many adults with chronic pain. How many are there, and what are the risk factors for chronic pain? Dahlhamer and colleagues address this subject in their current research.

Study Synopsis and Perspective

Chronic pain affects about 50 million US adults, and “high-impact” chronic pain, which interferes with life or work activities, affects around 20 million adults, new federal data indicate.

“Pain is a component of many chronic conditions, and chronic pain is emerging as a health concern on its own, with negative consequences to individual persons, their families, and society as a whole,” note the authors, led by James Dahlhamer, PhD, from the National Center for Health Statistics, part of the Centers for Disease Control and Prevention.

Their analysis of 2016 National Health Interview Survey data showed that 20.4% of US adults had chronic pain in 2016, and 8.0% had high-impact chronic pain. Both types of pain were more prevalent in women than men (20.8% vs 17.8% and 8.9% vs 7.0%, respectively).

Both types of chronic pain were also more prevalent among older adults, veterans, those previously but not currently employed, those living in poverty or rural areas, and those with public health insurance.

The study was published September 14 in the Morbidity and Mortality Weekly Report, in time for Pain Awareness Month.^[2]

$560 Billion in Direct Costs

Chronic pain and high-impact chronic pain have been linked previously to restrictions in mobility and daily activities, dependence on opioids, anxiety, depression, and poor quality of life, the authors write.

Chronic pain contributes to an estimated $560 billion each year in direct medical costs, lost productivity, and disability programs, they note.

As reported by Medscape Medical News, the federal government’s National Pain Strategy, released in the spring of 2016, marked the nation’s first coordinated plan for reducing the burden of chronic pain.

The plan recognized the need for better data to inform action and called for better estimates of chronic pain and high-impact chronic pain in the general population.

Dr Dahlhamer and colleagues say their report “helps fulfill this objective and provides data to inform policymakers, clinicians, and researchers focused on pain care and prevention.”

The study had no commercial funding. Dr Dahlhamer has reported no relevant financial relationships. One author has received honoraria for serving as a member of a research grant review board for the American Pain Society and serves as senior editor for Pain Medicine. Another author has received grants from Pfizer Inc as an investigator of the use and misuse of opioids at Kaiser Permanente Washington Health Research Institute and from inVentive as coinvestigator for US Food and Drug Administration-mandated postmarketing surveillance studies of extended-release opioids.

Morb Mortal Wkly Rep. 2018;67:1001-1006.

Clinical Implications

• Rates of any opioid and high-dose opioid prescriptions have fallen substantially in the United States from 2012 to 2017, but 17% of Americans still received at least 1 opioid prescription in 2017. Communities with higher rates of opioid prescriptions have higher concentrations of non-Hispanic white residents, as well as more primary care physicians and dentists.
• Approximately 1 in 5 US adults has chronic pain, and the rate of significant disability resulting from pain is 8%. Being a woman, poverty, public health insurance, and non-Hispanic white race were associated with higher rates of chronic pain.
• Implications for the Healthcare Team: The healthcare team should try to use local resources to present an effective and multidisciplinary approach to treating the many US adults with chronic pain.

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