“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
CDC Opioid Restrictions Reading List (as of June 22, 2017)
In March 2016, the CDC published a guideline for opioid prescribing, which is being codified into laws, even though it was intended only as a guideline for PCP doctors.
Pain itself is hard to live with but the latest restrictions on opioid doses are imposing serious suffering on pain patients.
The posts below are all about the consequences of the guideline so far.
A California mom who welcomed a baby girl in November is suing her doctor and the hospital she gave birth in after she claims she underwent an emergency caesarian section without anesthesia.
According to the lawsuit obtained by NBC 7 and filed on July 13, Delphina Mota and her fiancé, Paul Iheanachor, arrived at Tri-City Medical Center in Nov. 15 for the birth of their daughter and requested an epidural before a planned vaginal delivery.
Mota contends that Dr. Sandra Lopez oversaw her care, and that Dr. David Seif administered the epidural to numb her from the waist down. She also says she was given Pitocin to help advance her labor.
However, on Nov. 16, it was determined that Mota’s blood pressure dropped and that the baby’s heart rate was difficult to read, prompting Lopez to call for an emergency C-section, in which the baby is taken out through the mother’s abdomen.
C-sections account for about 1 in 3 births in the U.S., with the Centers for Disease Control and Prevention (CDC) reporting that in 2016, C-sections accounted for 31.9 percent of all U.S. births.
According to the lawsuit, Seif was paged multiple times, but did not respond, so nine minutes later, “the C-Section was performed by Defendant Sandra Lopez, M.D.” without anesthesia. Mota claims Lopez instructed staff to “strap her down” to the operating table before cutting her open.
The lawsuit claims Seif entered the room after multiple incisions were made, and that Mota had been crying and screaming because she could “feel everything that was happening, and was also pleading for help, and for Defendants to stop cutting and hurting her.”
“If somebody put a knife in your stomach and cut you open, and had their hands on your insides, and ripped your baby out, you know,” Iheanachor told NBC 7. “I just tried to put myself in her shoes. Just tried to wrap my mind around how it would feel to basically be gutted like a fish.”
Mota and Iheanachor, whose baby did not suffer any complications during the delivery, allege that the hospital and staff were careless and negligent and that Mota suffered permanent and significant injuries and emotional distress.
“As a direct and legal result of the above described negligence, Plaintiff Delphina Mota, underwent excruciating and unnecessary pain and suffering, until she eventually passed out from the pain,” the lawsuit said.
We are a group of attorneys, researchers, and journalists concerned about unintended consequences of prescription drug surveillance. We are looking for patients or health care providers who have had negative personal experiences with Prescription Drug Monitoring Programs. Answers are confidential. For some respondents we may request a follow-up.
On Tuesday, KSTP received documents specifically to the death of Prince in the days before he was found dead at Paisley Park.
The documents touch on Prince’s plane making an emergency landing in Moline, Illinois. The DEA documents indicate Prince had to be carried off that plane and placed on a cot. The documents indicate he was only taking three to five breaths per minute. Paramedics had to give him four milligrams of Narcan for him to regain consciousness.
KSTP spoke with Prince’s cousin Charles ‘Chaz’ Smith on his thoughts about the new information.
In this Feb. 4, 2007, file photo, Prince performs during the halftime show at the Super Bowl XLI football game in Miami.
Chris O’Meara/AP
“After you’ve taken a Narcan shot, they should observe you. You should be somewhere where they can check on you 24 hours to 48 hours,” he said.
Hospital paperwork says Prince was suffering from a drug overdose. That same paperwork indicates throughout his stay Prince continuously refused blood draws and EKG tests even after several doctors and a nurse told him of the importance of having it done.
Smith was asked whether religion or a distrust of medical professionals played a part in Prince refusing help.
“I would say it was both of them things and then it might have been the entourage maybe not knowing what to do to override something like that. Religion’s pretty heavy and he was a spiritual man,” Smith said.
The documents go on to say Prince or someone with him arranged for a jet card program like Jettly to bring him back to Chanhassen.
SUFFOLK, Va. (WAVY) — Stephanie Godfrey says she was eating dinner last week when emails started flooding her inbox.
“I have watch, so it started vibrating a lot, so I look down and it was Express Scripts, Express Scripts, Express Scripts,” said Godfrey
Godfrey says she uses the company Express Scripts, which is a pharmacy benefit manager that provides people access to medicine they need.
So she thought the emails could be about prescription for her household.
But when the emails kept coming in in bulk, and she ended up with 9,000 of them, she knew something was wrong.
She realized these emails were about other people’s prescriptions.
“When you open it you can just see the last four of the prescription number and it’ll say credit card and that’s when we realized these aren’t ours,” said Godfrey.
Godfrey called the company.
“I spent an hour and 24 minutes on the phone with them,” she said.
But the emails kept coming.
“The whole time I’m thinking what if I’m not the only one?” said Godfrey.
Godfrey knew she wouldn’t do anything with the emails, but was worried someone else was getting them too.
10 On Your Side reached out to the company on Friday, and Godfrey says it was only after our call that the emails stopped.
Express Scripts sent 10 On Your Side these statements:
“We are aware of the issue. It was caused by an error in our system which has been addressed. It is very limited in scope – only two Express Scripts members have received emails in error and we have been in contact with both of them to ensure no information is compromised. We regret the error, and reacted as soon as we were made aware of it.
As always, we are committed to protecting patient information. Our initial research indicates that limited personal information was in the e-mails. Additionally, our research indicates that no individual last names or identification numbers were included.”
They later added, “In talking to our information security team, a few more things to share. The member’s email preferences were to not receive personal health information, and from our analysis, it appears that she did not receive any PHI in the emails that were sent to her.While it is regrettable this happened, it is important to understand that PHI — like a name of a medicine or a medical condition — does not appear to have been shared in the emails.”
CBS46 reporter Natalie Rubino is spearheading an in-depth investigation.
It centers on the VA Pharmacy in Decatur and accusations it failed to properly fill prescriptions for a veteran in constant pain.
James Yarbrough is on several different medications to manage his pain. We investigated his claims for three months. The documents show Yarbrough sometimes receives his meds from the VA Pharmacy late or he’s given the wrong prescription. This has all caused even more pain and has taken an emotional toll on Yarbrough. Right now he doesn’t see an end in sight.
Yarbrough enlisted in the Air Force in the 90s.
“I was at my duty station at Tyndall Air Force base in Panama City, Florida. I got into a bad car wreck and I also hurt my back loading an A-9,” Yarbrough told Rubino.
Most of the pain is in Yarbrough’s neck and back.
“I’ve got three blown disks, at T-8, T-9 in the center of my back. I got peripheral nephropathy down both of my my legs and yesterday I just got nerve burns, they hit four in my leg,” he said of his condition.
Dr. David Rosenfeld of Alliance Spine and Pain helps manage the veteran’s pain.
“He’s on a medication called Gabapentin which is used to stabilize nerves. He also uses a little bit of opioid and then probably most notably he has what’s called an intrathecal drug reservoir. So, he’s got a pump that delivers pain medication around the clock into his spinal fluid,” Rosenfeld said.
For years those medications have been crucial to Yarbrough getting through every day life.
Until last October, when the VA suddenly failed to fill some of the veteran’s life saving prescriptions.
“This is neglect. And it’s the pure definition of abuse,” Yarbrough said.
A freedom of information act request filed by CBS46 shows that the Atlanta VA Pharmacy mailed Yarbrough’s meds to the wrong veteran instead of to Yarbrough’s father’s home as instructed.
“I started calling and calling because I did not get that medication.”
Yarbrough corrected his address with the VA and filed a HIPPA violation against the pharmacy. But since then it’s only gotten worse.
“My doctor faxes it in. Then I have to call the pharmacy. They say we didn’t get it. I have to call the doctor again and say, ‘did you get a fax receipt?’ He says, ‘yes.’ I say can you fax it again and then I have to call everybody, anybody and everybody.”
Yarbrough says this happens every month.
According to the documents CBS46 obtained, some months the VA fails to fill certain prescriptions, other months, the meds arrive far too late.
“When they did send the medications, they’d send it so far out I’d have to withdraw off of it,” Yarbrough said.
But that’s not all.
Yarbrough has an internal pump that can dispense Narcan in the case of an overdose.
“[This is post marked] April 17th, 2018. I was supposed to have this by January.”
Our Freedom of Information Act request revealed that in April of 2018 the V.A mailed Yarbrough his Narcan not only four months late but it was only a fraction of his prescribed dose and it had expired 6 months prior.
It took over a month for the VA to fulfill CBS46’s request for the documents. When we did receive them, an entire page was redacted. Raising the question, what is the VA holding back?
A spokesperson for the VA tells CBS46 the redacted information is protecting the VA employees involved.
Yarbrough says he feels retaliated against.
“I do sometimes feel what did I do wrong? What have I done?”
He says he doesn’t know how much longer he can take the pain.
“The end all could’ve been death and it still can be if they continue down the road they’ve taken,” Yarbrough said.
CBS46 made multiple requests to interview the director of the Atlanta VA and the director of VA Pharmacy about Yarbrough’s case. We were denied each time.
As the feds crack down on opioid prescriptions, patients are taking their own lives, doctors are losing their jobs and overdose rates continue unabated.
Meredith Lawrence’s late husband died by suicide after his opioid pain prescription was severely restricted.
Jay Lawrence, an energetic truck driver in his late 30s, was driving a semitrailer across a bridge when the brakes failed. To avoid plowing into the car in front of him, he swerved sideways and slammed the truck into a wall, fracturing his back. For more than 25 years, he struggled with the resulting pain. But for most of that time, he managed to avoid opioid painkillers.
In 2006, his legs suddenly collapsed beneath him, due to a complex web of neurological factors related to his spinal cord injury. He underwent multiple surgeries and tried many medications to alleviate his pain.
The next year, he began to experience some semblance of relief when his doctor prescribed morphine, one of a class of opioid drugs. By 2012, he was taking 120 milligrams per day.
But this isn’t a story about opioid addiction. Lawrence managed a relatively productive, happy life on the medication for the better part of 10 years.
“This isn’t the life I thought I’d have,” he told his wife, Meredith Lawrence, in December 2016. “But I’m all right.”
Living on disability payments, he could still walk around their two-bedroom trailer home using his cane, take a shower on his own and, on his good days, even help his wife make breakfast.
Then, in early 2017, the pain clinic where he was a patient adopted a strict new policy, part of a wide-ranging national effort to respond to the increase in opioid overdose deaths.
Citing 2016 guidelines from the U.S. Centers for Disease Control and Prevention, her husband’s doctor abruptly cut his daily dose by roughly 25 percent to 90 mg, Meredith Lawrence said. That was the maximum dose the CDC recommends, though does not mandate, for first-time opioid patients.
The doctor also told Jay Lawrence that the plan was to lower his dose to 45 mg over the next two months, a cutback of more than 60 percent from what he had been taking.
At the end of that traumatic visit, his wife said, Jay Lawrence’s doctor dismissed their concerns and shared his own fear about losing his license if he continued to prescribe high doses of opioids. (When HuffPost followed up, the doctor declined to comment on the case, citing patient privacy.)
For a month, Lawrence suffered on the 90 mg dose. At times, his pain was so bad that he needed help to get out of the recliner, and when his wife looked over, she sometimes saw tears streaming down his face. He dreaded his next appointment when his dose would be slashed to 60 mg. In the weeks before that scheduled visit on March 2, 2017, Lawrence came up with a plan.
On the day of his appointment, on the same bench in the Hendersonville, Tennessee, park where the Lawrences had recently renewed their wedding vows, the 58-year-old man gripped his wife’s hand and killed himself with a gun.
Dustin Chambers for HuffPost
Meredith Lawrence sits in the living room of the home in Gainesville, Georgia, that she bought after her husband’s death.
There are at least nine million chronic pain patients in the United States who take opioid painkillers on a long-term basis. As law enforcement and medical regulatory bodies try to curb the explosion in opioid deaths and the rise in illegal opioid use, they have focused on reducing the overall opioid supply, whether or not the drugs are provided by prescription.
There’s mounting evidence this won’t work ― that curbing patient access to legal prescription opioids does not stem the rate of overdoses caused primarily by illegal drugs ― and that patients are being denied desperately needed relief. There are also troubling indicators that cutting back on opioids increases the risk of suicide among those with chronic pain.
Some chronic pain patients and advocates have even begun compiling lists of individuals they know who have died by suicide after they were no longer able to treat their pain with opioid medication.
“There is no doubt in my mind that forcibly stopping opioids can destabilize some of the most vulnerable people in America,” said Dr. Stefan Kertesz, a professor of medicine and an addiction researcher at the University of Alabama at Birmingham. “And the outcomes for those folks include suicide, overdose and falling apart medically.”
I mean, people need to take some aspirin sometimes and tough it out a little.Attorney General Jeff Sessions
In late January, Attorney General Jeff Sessions announced a “surge” in Drug Enforcement Administration activity targeting pharmacies and physicians that, in the agency’s view, oversupply opioids. In February, the Justice Department doubled down with the announcement of a new task force that would focus on manufacturers and distributors of opioids. In March, President Donald Trump unveiled a plan to lower opioid prescriptions by a third within three years. And in late June, the federal government arrested 600 people, including 165 medical professionals, for allegedly participating in $2 billion worth of fraud schemes involving opioids.
The Trump administration’s efforts are dramatic even within the context of the CDC’s opioid dose guidelines. The guidelines were originally intended to advise primary care physicians treating chronic pain patients and other pain sufferers. They were urged to exercise caution in prescribing opioids, to use alternatives whenever possible and to prescribe daily doses of no more than 90 morphine milligram equivalents (MME) for new opioid users.
For pain patients like Jay Lawrence who had already been on opioids for years, however, the guidelines simply recommended regularly assessing the harms and benefits of the dosage. They didn’t advise either mandatory cutoffs or any set limits. (The Tennessee Department of Health’s guidelines would also have allowed Lawrence to stay at 120 mg of morphine when prescribed by a pain specialist.)
But “the CDC guidelines have been weaponized,” said Kertesz. The ramped-up enforcement by the DEA and state regulators has led some doctors to choose caution and to overcorrect in their prescribing, lest they lose their ability to practice medicine at all. Kertesz decried these policies as “simplistic” in a definitive new article published last week in the journal Addiction.
In February, Sessions struck a particularly harsh tone by suggesting that the fate of chronic pain patients was not high on his list of concerns. “I am operating on the assumption that this country prescribes too many opioids,” the attorney general said. “I mean, people need to take some aspirin sometimes and tough it out a little.”
Attitudes like that are based on a series of mistaken assumptions about pain, according to Dr. Thomas Kline, a North Carolina-based family practitioner and former Harvard Medical School program administrator. Kline regularly updates a list of pain patients, published on Medium, who’ve killed themselves in the wake of draconian restrictions on pain medication.
“I ask people to imagine the very worst pain they’ve ever experienced in their lives,” Kline said. “And then that they’re denied relief by a doctor with the one medicine proven effective for pain control for 50 centuries.” (Historical records show that people in ancient Mesopotamia cultivated the poppy plant for medical use.)
The CDC guidelines have been weaponized.Dr. Stefan Kertesz
The government’s aggressive focus on doctors and patients is unlikely to address the very real menace of opioid-use disorders and sharply escalating overdose deaths. Fraud ― driven by pharmaceutical company policies ― and diversion ― the phenomenon of prescription medications being sold as street drugs ― initially spurred a wave of opioid abuse in the late 1990s, as some doctors turned their practices into pill mills. But new reports by the CDC and a drug data firm, the IQVIA Institute for Human Data Science, suggest that prescription drugs play a much smaller role in today’s crisis.
The reports show that total opioid prescriptions dropped 10 percent in 2017 ― the sharpest annual decline in such prescribing in 25 years. While opioid prescriptions peaked back in 2010, the studies found that growth rates in opioid-linked deaths, overwhelmingly due to illegal fentanyl and heroin, have skyrocketed in the last seven years.
Still, the CDC’s guidelines have triggered restrictive laws in at least 23 states that mandate ceilings on opioid dosage. (Oregon, in fact, is moving to taper dosages down to zero for all Medicaid chronic patients over a year.) That makes relief less attainable for pain patients and threatens the practices of doctors who treat them. These laws have been augmented by the growth of state prescription monitoring programs that use the software NarxCare, which is designed to flag addiction but can also rope in pain patients based on their prescription history and use of multiple doctors.
And in June, the House of Representatives passed over 50 bills that would establish dramatic new restrictions on opioid prescribing, eliciting alarm among patients and some disability rights groups.
The side effects of the current enforcement efforts are disturbing enough, from patients denied relief to drug shortages to suicides.
No health agency has kept track of all pain-related suicides that may be linked to doctors cutting back on prescriptions. But some preliminary findings from Department of Veterans Affairs researchers indicate that VA pain patients deprived of opioids were two to four times more likely to die by suicide in the first three months after they were cut off, compared to those who remained on their pain medications.
That study isn’t without flaws. Veterans die by suicide at higher rates than average ― currently accounting for 20 suicide deaths a day ― so they are not a nationally representative sample. And the VA study, which was released at a national opioid summit in early April, has not yet been submitted for peer review.
But another study, published last year in the peer-reviewed journal General Hospital Psychiatry, looked at nearly 600 veterans who in 2012 were cut off from dosages after long-term opioid use and found similar results. Twelve percent of the vets showed suicidal ideation or took violent action to harm themselves ― a rate nearly 300 percent higher than the overall veterans community.
“To protect people, you have to take care of the patient, not the pill count,” said Kertesz, who worked on the VA’s April 2017 study but spoke to HuffPost only as an independent researcher. “The findings suggest that the discontinuation of opioids doesn’t necessarily assure a safer patient.”
Leah Ilten, a 53-year-old physical therapist who lives in Kennewick, Washington, told HuffPost that as her 86-year-old father lay dying of pancreatic cancer in a hospice, the medical staff ignored her pleas to provide appropriate opioid pain relief, even cutting his dosage in half on the last day of his life. A few days earlier, when he was in the hospital, one nurse explained to her that opioids could lead to an overdose or could potentially cause the man, who lay moaning in pain, to “get addicted.”
“I was horrified,” Ilten said.
In mid-April, the DEA responded to the injectable opioid shortage by lifting production quotas. An agency spokesman told HuffPost that it was “a manufacturers’ problem, not the quotas,” while asserting that progress is being made.
There have been production issues, including Pfizer’s foul-ups with a plant in Kansas. But the DEA’s delay in taking action ― shortfalls were flagged in February in a letter from the American Society of Anesthesiologists and other health groups ― definitely contributed to the shortage, according to Dr. James Grant, president of the ASA. He told HuffPost that quotas were among the factors creating the crisis.
I’m not willing to go back to the state I was in before I started treatment.Anne Fuqua
Faced with the hardline national crackdown on opioid prescriptions, people with chronic pain are trying to raise awareness of the suffering caused by the loss of medications. Some are gathering the names of those patients who ended up taking their own lives, both as a memorial to those who died and as a protest against the health establishment that has seemingly abandoned them. Others are seeking comfort from each other on social media.
Lelena Peacock, who declined to name her southeastern city of residence for fear of retaliation from doctors, is struggling with how to treat the pain associated with fibromyalgia. The 45-year-old found that her social media posts drew other pain patients who turned to her for help.
By her own count, Peacock has thus far convinced more than 70 chronic pain patients to call 911 or suicide prevention hotlines instead of killing themselves.
For Anne Fuqua, a 37-year-old former nurse from Birmingham, Alabama, the motivation for compiling a list of chronic pain-related suicides is to track the damage done by what she sees as policies that have left people like her behind.
“There’s so many people who have died,” she said. “We have to remember them.”
Fuqua has an incurable neurological illness known as primary generalized dystonia that causes Parkinson’s-like involuntary movements and painful muscle spasms. She started taking about 60 mg of Oxycontin a day in 2000. Her doctor began to limit her access to high doses of opioids in 2014, the same year she started chronicling those friends who had killed themselves or otherwise died after being denied pain medications. Her informal list is now up to roughly 150 people, augmented by lists that other pain patient advocates have compiled.
On July 9, Fuqua joined other chronic pain patients at a meeting at the Food and Drug Administration campus in Maryland to express their fears and outrage at the cutbacks. Sitting in the front row in her wheelchair, she told FDA officials about that list and declared, “I’m not willing to go back to the state I was in before I started treatment.”
Courtesy of Anne Fuqua
Anne Fuqua needs exceptionally high doses to manage her pain because of opioid malabsorption.
Fuqua’s own difficulties are compounded by the fact that her body does not respond to even large doses of opioids the way others do ― she suffers from severe malabsorption that hampers her ability to benefit from everything from opioids to vitamin D. Since 2012, she has relied on a strikingly high daily regimen of 1,000 MME of opioids, including fentanyl patches, to manage her pain.
But her physician, Dr. Forrest Tennant, was driven to retire this year after a DEA raid and investigation. The Los Angeles-area physician mailed her a final series of prescriptions, which will run out at the end of July.
“It’s terrifying,” she said looking at her future. “If these were people who had asthma or diabetes and weren’t stigmatized because of opioids, this wouldn’t be allowed to happen.”
Another doctor has quietly stepped forward to continue treatment for Tennant’s remaining patients, Fuqua said, although there’s no assurance that this physician won’t also be investigated in the future.
If these were people who had asthma or diabetes and weren’t stigmatized because of opioids, this wouldn’t be allowed to happen.Anne Fuqua
The raid on Tennant’s home and office last November illustrates the hard-line regulatory and enforcement approach that critics say doesn’t distinguish between pill-mill doctors who deserve to be shut down and legitimate pain doctors who use high-dosage opioids. The wide-ranging search warrant served to Tennant essentially accused him of drug trafficking even though he’d earned a national reputation for deft treatment of ― and research about ― pain patients.
“He’s highly respected and prominent in pain management,” said Jeffrey Fudin, a clinical pharmacy specialist who heads the pain pharmacy program at the Albany Stratton VA Medical Center in Albany, New York, and serves as an associate professor at the Albany College of Pharmacy and Health Sciences. “Most of his patients had no other options, and they came from around the country to see him.”
Tennant was known for taking on difficult-to-treat patients, including those suffering from pain as a result of botched surgeries and other forms of malpractice. His research included innovations in the use of hormones to alleviate pain and lower opioid use up to 40 percent, as well as work on genetic testing for enzyme system defects that lead to opioid malabsorption.
“The DEA can trigger an investigation every time they misapply the CDC guidelines without paying attention to the population the physician treats or issues of medical necessity,” said Terri Lewis, a patient advocate and a Ph.D. clinical rehabilitation specialist with Southern Illinois University who trains clinicians on how to manage seriously ill patients with incurable pain.
Special Agent Timothy Massino, a spokesperson for the DEA’s Los Angeles division, declined to comment on the agency’s approach to Tennant. “It’s an ongoing investigation,” he noted.
Tennant’s isn’t alone. Physicians must now balance their prescribing obligations to their patients with legitimate fear for their livelihoods.
DEA enforcement actions against doctors have risen some 500 percent in recent years ― from 88 in 2011 to 449 last year, according to an analysis of the comprehensive National Practitioners Data Bank by Tony Yang, a professor of health policy at George Washington University. Even though that’s a relatively small number of arrests compared to the roughly one million physicians in the country, such arrests can have an outsized impact.
“They make big news, and they serve as a deterrent for physicians whose specialties require them to use a lot of pain medications,” Yang said. “It makes them think twice before prescribing opioids.”
Dustin Chambers for HuffPost
Meredith Lawrence shows the tattoo she got after her husband’s death. The bluejay represents her husband, Jay; a cup of coffee is the way she loves to start her day; and the quote is “Sail away with me, what will be will be.”
Dr. Mark Ibsen of Helena, Montana, found himself in a five-yearbattle against the state licensing board that’s still not over ― even though a judge last month reversed the board’s decision to suspend his license because of due process violations. The court has remanded the case back to the licensing board for potential further investigation of his opioid prescriptions, but Ibsen has decided he won’t resume his medical practice.
That’s bad news for Montana, which has the highest rate of suicide in the country, according to the CDC. What’s more, chronic pain-related illnesses account for 35 percent of all the state’s suicides, as a recent state health department study found.
In the course of his fight with the medical board, the 63-year-old doctor said three of his former chronic pain patients have killed themselves after he and other doctors stopped prescribing opioids. The first of those patients died shortly after attending a hearing to show his support for Ibsen.
The deaths of pain patients haunt those who treated them and loved them. Meredith Lawrence, who sat with her husband to the very end, said, “It was as horrifying as anything you can imagine.”
“But I had the choice to help him or find him dead someday when I came home,” she added.
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 anti-opioid crusaders 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,” Dr. Kolodny said. “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.
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.”
Hundreds of gun owners in Florida have been ordered to give up their guns under a new law that took effect after the deadly Parkland shooting in February, according to a report published Monday.
The Risk Protection Order, signed by Florida Gov. Rick Scott just three weeks after a gunman killed 17 people at Stoneman Douglas, aims to temporarily remove weapons from gun owners who have been deemed by a judge to possibly be a threat to themselves or others.
Roughly 200 firearms have been confiscated in the state since the law was enacted, Sgt. Jason Schmittendorf, of the Pinellas County Sheriff’s Office, told WFTS-TV. “Around 30,000 rounds of ammunition” were also taken, he said.
A five-person team in the county that’s worked solely on the risk protection law reportedly has filed 64 risk protection petitions in court. Broward County, according to the news outlet, has filed 88 risk protection petitions since March.
“It’s a constitutional right to bear arms and when you are asking the court to deprive somebody of that right we need to make sure we are making good decisions, right decisions and the circumstances warrant it,” Pinellas County Sheriff Bob Gualtieri told the station in defense of the task force.
Every petition filed under the order in Pinellas County has so far been granted by the judge, according to the report.
The first gun seizure under the law occurred in April when Florida authorities confiscated an AR-15 semiautomatic rifle from an Army veteran.
Jerron Smith’s gun was seized when he refused to surrender it voluntarily, the Broward County Sheriff’s Office said at the time. The officers also seized a .22 caliber rifle he owned, hundreds of rounds of ammunition, a bump stock and numerous other weapon-related items.
In addition to confiscating guns, the law also raised the age to buy a rifle to 21 and established a three-day waiting period on gun purchases.
