Should corticosteroids be declared experimental for ESI’s – and not paid for ?

FDA Warns About Dangers of Epidural Steroid Injections for Back Pain

www.fibrowomen.com/fda-warns-about-dangers-of-epidural-steroid-injections-for-back-pain

The Food and Drug Administration has just issued what’s called a “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous. The alert says: “Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

Epidural steroid injections – and catastrophic injuries from them – were the subject of my debut investigation for The Dr. Oz Show almost exactly a year ago. (You can watch the video here and read the web article here.) The epidural space is an area between the spinal cord and the bony structure of the spine.

Our investigation revealed that the steroids – called corticosteroids – used for epidural injections are not even FDA approved for this purpose and yet ESIs are done nearly 9 million times a year, according to an analysis by Dr. Laxmaiah Manchikanti.

In addition to informing the public via its Medwatch Alert, the FDA said, “We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.”  Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

The new warning will be a more prominent reminder to doctors that injecting steroids into the epidural space, just outside the spinal cord, has risks. But the warning failed to list all of the possible adverse reactions. Those reactions are named in the fine print of current drug labels, and include: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”

In 2009, the FDA convened a group to study the safety of some types of epidural steroid injections. In its new notice, the FDA said that group’s recommendations still are not ready and will be released when they are.

Dennis Capolongo of the EDNC, a group that has been campaigning against epidural steroid injections for years, called the FDA’s new warning “bitter sweet” because it did not go further.  Capolongo wants the FDA to go beyond telling doctors that injecting steroids into the epidural space COULD have severe side effects and instead state that they MUST NOT do it.

In February of this year, Australian and New Zealand health authorities came out with exactly that stronger language, stating that steroids like this, “MUST NOT be used by the intrathecal, epidural, intravenous or any other unspecified routes.” The South African government issued similar warnings, according to Capolongo.

Since the FDA is still actively studying these procedures, it will be interesting to see if the agency takes any further steps. If and when it does, you can bet I’ll pass the information along.

Pam Bondi sues makers of opioids, says it’s time they pay for the pain they caused

Pam Bondi sues makers of opioids, says it’s time they pay for the pain they caused

https://www.miamiherald.com/news/state/florida/article211185174.html

Florida Attorney General Pam Bondi announced Tuesday that she had filed “the most comprehensive lawsuit in the country” against the largest manufacturers and distributors of opioids, blaming them for creating an opioid crisis that has killed more than 10,000 Floridians.

Flanked by police, firefighters and families of opioid victims, Bondi said she wanted “billions” from the companies, which she said misled patients about addictive drugs and ignored people who were ordering suspicious amounts of them.

“It’s time the defendants pay for the pain and the destruction that they have caused,” Bondi said.

The lawsuit targets some of the largest drug makers in the country, including Purdue Pharma, the creator of the opioids OxyContin and Dilaudid; Endo Pharmaceuticals, which makes the drugs Percocet and Opana; and Johnson & Johnson and some of its subsidiaries, which make the drugs Duragesic and Tapentadol.

Distributors AmerisourceBergen, Cardinal Health and McKesson also “failed to report suspicious orders while knowing these customers were filling an inordinate number of prescriptions,” the lawsuit alleges.

Bondi said that the companies behind these drugs also created “front groups” that promoted and marketed opioids. She held up literature from these groups that she said was full of misinformation and downplayed the addictive nature of the substances.

For example, in “Treatment Options: A Guide for People Living with Pain,” the authors alleged that “despite their great benefits, opioids are often underused” because “heathcare providers may be afraid to prescribe them, and patients may be afraid to take them.”

The long-awaited lawsuit, filed in Pasco County before Circuit Judge Declan Manfield, seeks to recoup the costs for victims and for cities and counties that have spent millions fighting the crisis.

It is an epidemic that Bondi said is indiscriminate in its impact, from the elderly and active teenagers to pregnant mothers and the infants born to them.

“Instead of milk, these babies were coming into the world getting morphine or methadone,” she said.

The suit alleges that the companies violated the Florida Deceptive and Unfair Trade Practices Act, the Florida RICO Act and common law public nuisance. Distributors were also negligent, according to the suit.

The complaint lays out the common narrative about the modern opioid crisis, told over the last two decades by journalists, federal authorities and lawyers: Companies pushed highly addictive pills onto the public without telling people how harmful they were. Many of those people became addicted, and some turned to heroin when they couldn’t get pills.

Drug companies aggressively sold their opioids, downplaying how addictive they were and paying “medical professionals” to “endorse and promote the use of opioids,” Bondi’s complaint states. The complaint calls them “key opinion leaders,” or “KOLs.”

Those “key opinion leaders” were paid by the companies to speak at conferences, given consulting fees, travel and lodging expenses, and food and beverage expenses as long as they touted opioids for chronic pain relief.

According to the suit, the companies paid “front organizations” that portrayed themselves as objective advocates for patients or responsible professional associations that provided misleading claims that opioids were safe without disclosing any of the risks.

Drug distributors violated their duty by shipping hundreds of millions of opioids into Florida without “sounding the alarm or stopping the shipments,” the lawsuit states.

The complaint notes that a single pharmacy in Hudson, a Pasco County town of 34,000 people, purchased 2.2 million opioid pills in 2011 alone — 64 pills for every resident.

A spokesman for Purdue Pharma said they “vigorously deny these allegations and look forward to the opportunity to present our defense.”

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help the state of Florida address the opioid crisis, the attorney general has unilaterally decided to pursue a costly and protracted litigation process,” the spokesman said in a statement.

The case promises to be one of the largest lawsuits filed on behalf of Floridians, ranking alongside the multibillion-dollar Big Tobacco case of the 1990s and the 2010 BP oil spill.

But Bondi has been repeatedly criticized for taking so long to file. Already, hundreds of cities, counties and states have filed lawsuits against the same companies.

After Bondi’s announcement Tuesday, Democratic candidates applauded the filing but criticized the timing.

“I’m glad they are finally taking this long overdue step but remain disappointed it took them so long to do so,” said Gwen Graham, a Democratic candidate for governor.

State Rep. Sean Shaw, D-Tampa, who is running for attorney general, said, “It is disheartening that it took eight years of warnings, thousands of unnecessary deaths, and for her time in office to be coming to an end for Attorney General Bondi to finally acknowledge that Floridians have been facing an overwhelming opioid crisis.”

Shaw’s competitor in the Democratic primary, Tampa attorney Ryan Torrens, said the question Floridians should be asking is, “What took so long?”

Bondi said it’s taken this long to put together a compelling, comprehensive case.

Some lawyers said they did not apply to represent the state, citing an 8-year-old state law that caps contingency fees for lawyers hired by the attorney general at $50 million.

But Bondi said she had no trouble finding top attorneys. Of 52 firms that she said applied, Bondi settled on a team that includes local and out-of-state law firms, including attorneys Drake Martin and Rich Newsome, which handled, respectively, the BP oil spill and the Takata air bag case.

Bondi said she intentionally was not involved in the first round of selecting the lawyers but personally interviewed each of the finalists.

Bondi’s announcement was coordinated with attorneys general of Nevada, Texas, North Carolina, North Dakota and Tennessee, which also filed lawsuits Tuesday, according to Reuters.

Joining Bondi at Riverside Recovery of Tampa, a drug rehabilitation center, were Florida House Speaker Richard Corcoran and Agriculture Commissioner and GOP gubernatorial candidate Adam Putnam.

Bondi acknowledged that a settlement was likely. She could not say what the state is seeking in damages, but prophesied it would be in the “millions — billions, probably.”

She said she does not expect leaders at any of these companies to face jail time.

“I wish I could send someone to jail, but I can’t,” she said. “So we’re going after them financially.”

There were more than 3,000 opioid-related deaths in Florida last year and 2,000 deaths directly attributed to the drugs, a 27 percent increase from 2016, according to the preliminary findings of the Florida Department of Law Enforcement Medical Examiners Commission.

Pasco County Sheriff Chris Nocco called the companies “drug dealers” that were “pushing pills,” and he said that lawyers should go after the families that have profited.

The family that owns the company that makes OxyContin, for example, is one of the nation’s richest and has become one of the biggest donors to the nation’s top museums.

“Freeze all the assets of these companies,” Nocco said. “Freeze all the assets of the families benefiting from all this.”

Florida was one of the last states to implement a PMP program (E-FORCSE) in 2009… So all the data that would have indicated a large quantity of prescription opiates where being distributed throughout Florida..  From what I have heard.. there was a substantial increase in new pharmacy permits issued… so where was the Board of Pharmacy ?

The DEA had reports from the pharmacy wholesalers about the meds and amounts that were being sold in FL- so where was the DEA ?

When a prescription opiate is no longer in the possession of the person to whom it was prescribed.. it AUTOMATICALLY becomes an ILLEGAL OPIATE. How many people getting opiate Rx in FL from these “pill mills” where really drug diverters ?

If there was a mechanism in place to validate who the person really was that was going to these pill mills and getting opiate/controlled substance prescriptions filled… there bank accounts or assets could have been tracked to see if they were substance abusers or just in the business of diverting controlled substances.

Bondi talks about “chronic pain pts” and these opiates and if you read some of the literature and other information around these meds… low addiction is typically mentioned in treating chronic pain… which everyone who is paying attention … knows that is the truth.  It is medically inappropriate to prescribe long acting meds for acute pain.

Purdue Pharma is a private corporation so Bondi states that she is going to go after the family’s assets. All of the original family members who controlled the corporation during the “pill mill ” period are no longer living.

There are other corporations that have produce/sold opiates/controlled substances but they are all publicly held corporations and because of that …she can’t go after the stock holders assets.

I just wonder how many millions or hundred of millions of “profits” that were made by the people whose “business plan” was to make a profit by diverting these meds, but Bondi and these other state’s attorney general knows that there was millions made and it would take too much effort/expenses in trying to find these people…. probably because most used fake names and fake ID’s

But this is just typical of how our legal system and the attorney profession functions

thousands of people are dying every year from opioid overdoses, those who depend on pain management argue that no one is talking about them

https://www.wate.com/news/local-news/pain-patients-cry-out-amid-opioid-epidemic/1581698996

KNOXVILLE, Tenn. (WATE) – While thousands of people are dying every year from opioid overdoses, those who depend on pain management argue that no one is talking about them.

Debilitating pain has been a part of Raymond Kuykendall’s life for nearly 30 years. The simple act of bending over to feed his dog is difficult. 

He was a laborer and fell from a bridge when the Interstate 275/Interstate 40 flyover was under construction 30 years ago. It took more than a year before he could sit in a chair without being in a full body cast.

“I shattered my whole left side. It was like pick up sticks on the X-ray,” he said.

Kuykendall broke his back, lost a kidney, and suffered other internal injuries.

“They told my family for three days that I wouldn’t live,” Kuykendall said.

To relieve his pain, Kuykendall was prescribed by his doctor a cocktail of opioids, which became stronger and stronger every year. In July of this year, when Tennessee enacted one of the strictest opioid policies in the country, Kuykendall said his quality of life changed as his daily meds were cut back.

Kuykendall says he takes 30 milligrams of oxycodone four times a day, which is 60 milligrams less per day than what he used to take.

“It’s affected me in everything. Doing house chores, just getting through in life,” he said.

Steve Glass shared a similar story in August. He can’t get out of a chair without pain. Disabled for 27 years following a series of back surgeries, Glass has chronic, constant pain which affects him emotionally, physically and psychology. 

To ease his debilitation, his doctors prescribed 15 mg of oxycodone and 10 mg of Oxycontin.

“This is one third of what I was taking before the cuts in the medicine of everyone,” he said. “My quality of life has crashed.”

With changes in his pain management, Kuykendall believes he’s paying the price for the abuse by others.

“I just don’t see where it is my fault that people are overdosing on opioids, when I take mine the way I’m supposed to,” he said. “I’m the one that got cut back on my pain medicine because of all the other people out here doing stuff they shouldn’t be doing.”

More Tennesseans died last year from drug overdoses than from automobile crashes. Department of Health records show 1,776 Tennesseans died from drug overdoses in 2017. Prescription opioids are the most common drugs associated with overdose deaths which is one of the reasons why Tennessee has cracked down on the opioid epidemic.

However, Steve Glass believes those with chronic pain, due to their serious health issues, should be exempt from strict legislation. Raymond Kuykendall holds the same opinion. 

“I don’t think the government ought to be the one to dictate to the doctors what they can prescribe,” said Kuykendall.

“We’re dying, like the people who are overdosing. It’s just slower,” said Glass.

Just a few weeks ago, the Food and Drug Administration enacted what’s called the SUPPORT Act. In the legislation, the FDA supports developing drugs to treat pain that are not addictive, as well as the need to better understand the safety of existing opiods, to treat those millions of people with chronic pain. 

Those who fit that category say living with unrelenting pain and not receiving the care they deserve, needs to be addressed. They argue the pain crisis has been ignored too long due to the opioid crisis. 

Laugh of the day

See the source image

A teacher gave her fifth grade class an assignment:  Get their parents to tell them a story with a moral at the end of it.

The next day, the kids came back and, one by one, began to tell their stories.  There were all the regular types of stuff: spilled milk  and pennies saved.

But then the teacher realized, much to her dismay, that only Janie was left. “Janie, do you have a story to share?” 

”Yes ma’am. My daddy told me a story about my Mommy.  She was a Marine pilot in Desert Storm, and her plane got hit. She had to bail out over enemy territory, and all she had was a flask of whiskey, a pistol, and a survival knife.  She drank the whiskey on the way down so the bottle wouldn’t break, and then her parachute landed her right in the middle of 20 Iraqi troops. 

She shot 15 of them with the pistol, until she ran out of bullets, killed four more with the knife, till the blade broke, and then she killed the last Iraqi with her bare hands. 

”Good Heavens,’ said the horrified teacher. ‘What did your Daddy tell you was the moral to this horrible story? 

“Stay away from Mommy when she’s been drinking.”

CVS going to compete with primary care and other practitioners.. optional or mandatory if you have Aetna Ins ?

CVS to debut more health services after Aetna deal

https://www.beckershospitalreview.com/pharmacy/cvs-to-debut-more-health-services-after-aetna-deal.html

After its $69 billion acquisition of Aetna is finalized, CVS plans to introduce more health services, including chronic disease management, at select drugstores, according to CNBC.

CVS will open these concept stores early next year in an effort to improve health services and outcomes for patients at a lower cost.

The pilot sites will focus on several ways to manage costs, including optimizing and extending primary care and managing common chronic conditions such as diabetes, cardiovascular disease, hypertension, asthma and behavioral health. The sites may look at reducing avoidable readmissions by combining Aetna’s clinical programs with CVS stores and helping to improve outcomes for patients with kidney disease.  

“We’re making the consumer experience, which will be an increasingly important competitive differentiator, and we are hard at work creating a plan to differentiate CVS Health in these patient journeys with the goal of making them simpler and more personalized while making care more accessible,” CVS CEO Larry Merlo told CNBC.

CVS will pilot these programs at the initial concept stores to determine which are most effective and scalable across the retail pharmacy’s locations. Currently, CVS has about 10,000 stores and 1,100 MinuteClinics across the U.S. 

 

New members of Congress and new majority in the House – time to meet & talk ?

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

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

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.

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

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

WASHINGTON — An injectable drug that the manufacturer says is too dangerous to use along the spine is growing in popularity for back pain as doctors turn away from opioids.

The anti-inflammatory drug, called Depo-Medrol and made by Pfizer, is approved for injection into muscles and joints. Once a drug is approved, however, doctors may legally prescribe it however they see fit. And doctors have long given Depo-Medrol shots, or the generic equivalent, close to the spinal cord for painful backs, necks and conditions like spinal stenosis.

What few doctors or patients know is that Pfizer, faced with hundreds of complaints about injuries and complications related to the shots, asked the Food and Drug Administration to ban that type of treatment five years ago. The company cited the risk of blindness, stroke, paralysis and death — a request that neither the agency nor Pfizer made public.

The F.D.A. declined to issue a ban but toughened the label warning. Other countries — among them Australia, Brazil, Canada, France, Italy, New Zealand and Switzerland — heeded Pfizer’s request.

After concerns were raised about the off-label treatments, use of the injections declined. But the opioid epidemic appears to be spurring their popularity despite risks known to public health officials and doctors.

According to the F.D.A., back problems are the most common cause of disabling, chronic pain. Weekend classes to train physicians in the procedure are flourishing. Critics like Dr. Terri A. Lewis, a rehabilitation specialist and lecturer at the Southern Illinois University, say they are responsible for transforming pain clinics into “drill mills.”

And in June, as part of legislation to tackle the opioid crisis, the House of Representatives approved an increase in Medicare reimbursement for the procedure.

The number of Medicare providers giving steroid injections along the spine, including Depo-Medrol and other drugs, had increased 13 percent in 2016 from 2012. The number of Medicare beneficiaries receiving these injections is up 7.5 percent. The Department of Veterans Affairs reported a 17 percent increase in the injections from 2015 to 2017.

And total sales of brand name and generic Depo-Medrol grew 35 percent to $185 million from $133 million from 2015 to 2017, according to the IQVIA Institute for Human Data Science, a health data firm.

It’s a troubling trend to researchers and experts like Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University.

“The victims of our era of aggressive opioid prescribing are being exploited in some cases by interventional pain doctors, who will continue them on opioids in exchange for allowing them to perform expensive procedures that they don’t need,” said Dr. Kolodny, who is also executive director of Physicians for Responsible Opioid Prescribing. “These are not benign procedures. Patients can be harmed and are harmed.”

Pfizer, in 2013, quietly asked the F.D.A. and regulators in other countries to ban Depo-Medrol for epidural use. “It must not be used by the intrathecal, epidural, intravenous or any other unspecified routes,” the company wrote.

Image
A doctor preparing a Depo-Medrol shot to treat chronic back pain.CreditDr. P. Marazzi/Science Source

It is unusual for a drug company to request a contraindication for one of its own products. In this case, some doctors say Pfizer was worried about liability from the off-label use, which does not give a manufacturer the same degree of protection as approved uses.

When the F.D.A. authorized a stronger warning in 2014, it noted that giving steroid shots close to the spine could cause rare but catastrophic injuries or death. The warning applied to the entire class of epidural steroid injections, estimated at about nine million a year — and not to be confused with the pain blocks, often called epidurals, given to women during childbirth.

Now, interviews with dozens of pain specialists show that pressure to wean patients off opioids is prompting many doctors to refer patients to pain intervention specialists who promote the shots. The cost per shot varies widely, from $100 up to $800, with an additional fee going to the hospital or clinic where it is administered.

“The truth underlying it is that doing an injection is faster and results in higher reimbursements, compared to other ways of managing the same pain,” said Dr. James P. Rathmell, chairman of anesthesiology, perioperative and pain medicine at Brigham and Women’s Hospital. It was Dr. Rathmell who first brought the issue to the F.D.A. and oversaw a panel charged with recommending guidelines on safety.

“The use of injections has increased dramatically, yet the prevalence of back pain has remained relatively unchanged,” Dr. Rathmell said.

Doctors can choose among several types of epidural steroid injections. Depo-Medrol has a major share of the market. Epidural steroid injections in the cervical (neck) area and mid-back are considered the most dangerous.

They work like this: A steroid is injected into the epidural space within the spinal canal. Most of the injuries occur if the needle misses its target and directly injures nerves or places the drug into the spinal fluid or arteries, depriving the spinal cord of blood.

A review of F.D.A. records show that there were 2,442 serious problems reported from Depo-Medrol injections from 2004 through March 2018, including reports of 154 deaths. Pfizer declined to comment on the deaths, pointing to the product’s warning label: “Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.”

In West Virginia, the heart of the opioid epidemic, anesthesiologist Dr. Brian Yee said more general practice physicians are referring patients to his clinic for epidural steroid injections and other procedures, like spinal cord stimulation, than in past years.

Dr. Yee believes spinal injections are valuable if administered properly. But he worries that weekend classes aren’t sufficient training.

“With people trying to take away opioids now, we are opening up another doorway for people to overutilize other options that can be helpful with the right doctors and the right patients,” he said.

Carrie Flaten thinks she was one of the wrong patients. A self-described Montana cowgirl, Ms. Flaten badly injured her back and shoulder in a car accident at age 28 in 2007. Months later, she was still in terrible pain and began physical therapy, along with a series of epidural steroid injections.

At first the shots made her feel better. But the relief never lasted, and she ended up having so many Depo-Medrol and other injections over the years that a nurse started calling her “our pincushion.”

Her last shot, in late 2015, left Ms. Flaten in what she described as frequent excruciating pain, with difficulty walking, little bladder control and loss of sexual function. Ms. Flaten said she could not return to her job as a mechanic, and still has trouble keeping up with her children.

When Ms. Brandt went to a different clinic to seek treatment for her pain, they also told her they would only prescribe painkillers if she agreed to an epidural steroid injection, she said.CreditShawn Poynter for The New York Times

Ms. Flaten said her clinic has refused to give her any painkillers unless she resumes the injections — something she does not want to do. Had someone told her that Pfizer sought a ban on using the shots this way, “I would have said absolutely no,” Ms. Flaten said.

Sherry Brandt did say no, and claims that refusal led her pain clinic to dismiss her as a noncompliant patient. The 56-year-old Tennessee resident had suffered back pain for years, and received several epidural steroid injections that did not seem to harm her. But she said they did not help, either.

Physical therapy and opioid painkillers left her stable, but she still had difficulty standing or walking — which worsened after a back surgery several years ago. She said she became more reliant on painkillers until her doctor, nervous about continuing to prescribe them in the current climate, referred her to a local pain specialist. The clinic staff suggested more shots, but by then Ms. Brandt had discovered their risks and declined.

Then she got hit by a truck.

Ms. Brandt went to another pain clinic, where doctors also told her they would only prescribe painkillers if she agreed to an epidural steroid injection, she said. Again she declined, fearing it could worsen her condition. “It’s blackmail,” she said.

The clinics that Ms. Flaten and Ms. Brandt visited declined to comment.

Dennis J. Capolongo often fields calls from people like those patients. The former photojournalist became a patient advocate after epidural Depo-Medrol injections for hip pain in 2001 inflamed his nerves, leaving him bedridden for nearly three years.

Mr. Capolongo, who lives in Potomac, Md., said he still suffers from debilitating central nervous system disorders. He has been campaigning for years for the F.D.A. to ban Depo-Medrol for spinal use.

Pfizer said it cannot track how much Depo-Medrol is used for off-label shots. Company spokesman Thomas Biegi said without an F.D.A. ban, there was nothing Pfizer could do to stop the off-label shots.

“We believe this is a question of medical practice and defer to clinicians and pain experts who utilize these medicines in their practices for the treatment of pain conditions,” Mr. Biegi said.

Dr. Laxmaiah Manchikanti thinks that’s as it should be. Chief executive of the American Society of Interventional Pain Physicians, Dr. Manchikanti does not use Depo-Medrol in his own practice but believes it is safe for the lower spinal area.

In May, after the physicians’ group met with lawmakers on Capitol Hill, Representative John Shimkus, Republican of Illinois, proposed raising Medicare reimbursement rates for epidural steroid injections and other interventional procedures.

The doctors’ political action committee had donated $20,000 to Representative Shimkus’s 2016 and 2018 campaigns, according to the Center for Responsive Politics, which tracks political contributions. Democratic co-sponsor Raja Krishnamoorthi, of Illinois, also received a $10,000 donation during this election cycle, and $5,000 during his 2016 race.

The House approved the plan in June, which would reverse previous cuts of 16 to 25 percent. The Senate may consider whether to include a similar plan in its version of the opioid legislation.

Dr. James Patrick Murphy, an anesthesiologist and addiction specialist in Kentucky, believes that recent studies showing the shots do not work better than physical therapy for many patients are reason enough not to use them on so many patients. He also thinks they cost too much.

“The physician fee is usually somewhere between $100 and $300,” Dr. Murphy said, “but the hospital fee for the procedure, the separate fee, can be anywhere from $1,000 to $5,000. That’s a lot of expense for somebody when you really can’t promise you’re going to cure them.”

Kolodny:There is absolutely no need for this product to help soldiers on the battlefield… is ridiculous

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.”

Are the REAL FACTS of the opiate crisis really of a concern to DEA/DOJ and other bureaucrats

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.”