Will People in Pain Suffer Because of FDA’s Scary Opioid Warnings?

[tod evans]

Will People in Pain Suffer Because of FDA’s Scary Opioid Warnings?

https://www.peoplespharmacy.com/2016...ioid-warnings/

The FDA has followed the lead of the CDC in cautioning doctors about prescribing opioid pain relievers. Short-acting narcotics will now come with boxed opioid warnings about misuse, abuse, addiction, overdose and death. Longer-acting narcotics already come with such boxed warnings.

Short acting or immediate-release opioids include drugs like codeine, hydrocodone (Dolagesic, Lorcet, Lortab, Norco, Vicodin) or oxycodone. These drugs are fast acting and ease pain for four to six hours.

Long acting narcotics include methadone, levorphanol and controlled-release formulations of oxycodone (OxyContin), oxymorphone (Opana ER), fentanyl (Duragesic), methadone (Dolophine) and morphine (Avinza). The effects can last from eight to 24 hours or even longer.

The FDA’s Boxed Opioid Warnings Will be Scary:
Expect something like this with short-acting opioids:

“Hydrocodone exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death.”

Doctors will be discouraged from prescribing opioids unless they think the pain is really severe and for which “alternative treatment options are inadequate or not tolerated.”

In addition, the FDA will require that all narcotics carry a warning about drug interactions with certain other medications that could trigger something called serotonin syndrome. This condition can cause agitation, confusion, rapid heartbeat, elevated blood pressure, uncontrollable muscle contractions and elevated body temperature. Nausea, vomiting, incoordination and even hallucinations can also occur with serotonin syndrome, and severe cases can lead to unconsciousness and sometimes death.

The Impact of the FDA’s new Opioid Warnings:
We suspect that between the CDC’s recent Guideline about opioids and the new FDA warnings, many physicians will be reluctant to prescribe opioids at all, even when patients are in substantial pain. In addition, patients will be reluctant to take narcotics even if they are really hurting. There is already a great fear of addiction for many patients, and this is likely to scare them even more.

Will People in Pain Suffer Because of Opioid Warnings?
We recognize that there is a huge drug abuse problem in this country. It includes illicit drugs like cocaine and heroin as well as prescription opioids. Sadly, though, many people who are in severe pain may now have a much harder time accessing needed medicine. A veteran who has suffered grave injuries in Iraq or Afghanistan may find it harder to get pain relief. Someone who has had numerous surgeries and remains in pain could also suffer. And terminal cancer patients suffering severe pain may be afraid to take a narcotic for fear of “addiction.”

It will be interesting to see whether the new CDC Guideline and FDA warnings curtail abuse without causing people in severe pain to suffer.

[The norm today is Tylenol for oral surgery!]

Screen you doctor and dentist PRIOR to undergoing any procedures....

[Anti Federalist]

Umm, yes.

[tod evans]

A ‘civil war’ over painkillers rips apart the medical community — and leaves patients in fear

https://www.statnews.com/2017/01/17/...ement-opioids/

For Thomas P. Yacoe, the word is “terrifying.”

Leah Hemberry describes it as “constant fear.”

For Michael Tausig Jr., the terror is “beyond description.”

All three are patients struggling with chronic pain, but what they are describing is not physical agony but a war inside the medical community that is threatening their access to painkillers — and, by extension, their work, their relationships, and their sanity.

Two years after the United States saw a record 27,000 deaths involving prescription opioid medications and heroin, doctors and regulators are sharply restricting access to drugs like Oxycontin and Vicodin. But as the pendulum swings in the other direction, many patients who genuinely need drugs to manage their pain say they are being left behind.

Doctors can’t agree on how to help them.

“There’s a civil war in the pain community,” said Dr. Daniel B. Carr, president of the American Academy of Pain Medicine. “One group believes the primary goal of pain treatment is curtailing opioid prescribing. The other group looks at the disability, the human suffering, the expense of chronic pain.”

Pain specialists say there is little civil about this war.

“There’s almost a McCarthyism on this, that’s silencing so many people who are simply scared,” said Dr. Sean Mackey, who oversees Stanford University’s pain management program.

“The thing is, we all want black and white. We don’t do well with nuance. And this is an incredibly nuanced issue.”

Nuance does not matter to people like Tausig, 43, who has been unable to work or socialize since 2008, when the last of his five spinal reconstruction surgeries left him in constant pain.

He last got a taste of life without opioids a few years ago, when his pharmacy’s corporate parent imposed opioid-distribution limits, forcing him to find a new one.

“Those three days were among the worst of my life,” he said. “I wandered the house at night, legs shaking like a whirling mass of putty, sleepless and without respite from the pain.”

Now, with regulators and health industry leaders continuing to bear down on opioids, and the arrival of a new president whose statements indicate that he might further restrict opioid distribution, Tausig’s worries have deepened.

“It’s put the fear of God in me.”


The medical community’s battle over painkillers burst out into the open in late 2015, when the New England Journal of Medicine published a commentary in which two doctors argued that chronic pain patients should focus not on reducing the intensity of their pain, but on their emotional reactions to it.

The authors, Dr. Jane C. Ballantyne, the president of Physicians for Responsible Opioid Prescribing, and Dr. Mark D. Sullivan, argued patients should pursue “coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity.”

The pair argued that patients who mainly focus on pain intensity tend to escalate their doses of opioids and worsen their quality of life.

On NEJM’s website, the comments section devolved to a flame war more suited to YouTube than the staid pages of the nation’s top medical journal, with some accusing the authors of a lack of compassion, and others lauding them for a sane approach to public health and addiction prevention.

But the comments also laid bare a fundamental problem in the debate over opioid treatments: Neither side has much evidence about the benefits or consequences of long-term use because almost no such studies exist.

A few studies have identified a litany of side effects beyond addiction. One survey, by palliative care doctors Mellar P. Davis and Zankhana Mehta, pointed to symptoms including increased risk of depression, anxiety, cognitive impairment, and sleep apnea, among other issues. Patients with lung disease were also more likely to die when their treatment included opioids, according to the survey’s authors, who practice at Geisinger Health System.

Stanford’s Mackey said those risks are important to recognize. But, he said, nearly 15,000 people die a year from anti-inflammatory medications like ibuprofen. “People aren’t talking about that,” he said.


On a Monday morning last month, Mackey entered an exam room to greet one of his patients who uses opioids: an 81-year-old physician with a bad back.

The doctor, who agreed to be interviewed on condition of anonymity, said he’d routinely cycled to work until relatively recently, when a degenerative spinal condition worsened. Surgery in October failed to help, and now, he told Mackey, he can only get out of bed if he takes five opioid pills at dawn and sleeps another half-hour before rising.

The doctor wanted to find a way to address his back problem without the painkillers, which, he said, cloud his thinking.

Mackey spent nearly 30 minutes with him, talking about scans, symptoms, and previous treatments. He planned a follow-up consult in January, when another set of test results would arrive.

Over lunch, Mackey reviewed the case.

“Do you get any sense from him of drug-seeking behavior?” he asked. “Is he selling this stuff on the street or trying to score some synthetic fentanyl or heroin? No. All he wants to do is be more functional so he can see patients and be relevant and have a life.”

Mackey also wasn’t sure the opioids were causing the cloudiness. The patient’s cognitive issues could be the result of non-opioid medications he takes before sleeping, so dialing down the opioids without first exploring other options might harm him more. Without them, his pain would be so severe he would be relegated to bed.

“If you’re 81 and you stop getting out of bed, it’s a slippery slope,” he said.

Mackey, a past president of the American Academy of Pain Medicine, has built Stanford’s pain center into one of the nation’s most comprehensive and well-funded pain research operations. But he said doctors being trained there have grown increasingly fearful about prescribing opioids.

“In many cases that can be healthy, but I’d like to see a thoughtful, balanced approach,” he said. “Opioids are a tool — they’re more often a fourth- or fifth-line option for me.”

Mackey recalled the case of a patient who had crushed his foot in an accident and undergone 10 surgeries that failed to diminish his “burning, terrible pain.” The patient now relies on opioids.

“People will say, ‘This guy’s on way, way too much opioid medication, you have to take him off,’” Mackey said. “But guess what: He gets up every morning and goes to work and does his job, and he’s been on the same regimen for years and years and tried everything else first.”

Even some of Mackey’s colleagues have issues with that kind of thinking.

Dr. Anna Lembke, who practices alongside Mackey at Stanford’s pain clinic and is chief of the Stanford Addiction Medicine Dual Diagnosis Clinic, published a book about the opioid crisis last year. It was titled: “Drug Dealer, MD: How Doctors Were Duped, Patients Got Hooked, and Why It’s So Hard to Stop.”

Lembke believes that long-term opioid use can cause patients to perceive pain even after the original cause of pain has cleared. Some patients, she said, find themselves free of pain only once they have endured the often agonizing effects of opioid withdrawal.

“That’s what we’re seeing again and again,” she said.

Lembke believes people with chronic pain who have taken opioids daily for long periods may never be able to break their dependence on the drugs, and may need permanent doses of medications like Suboxone, which is commonly given to people with opioid addictions.

But chronic pain patients who have not yet started on opioids, she said, should only take them intermittently — “like every three days or so” — to avoid addiction.

The American culture has grown too intolerant of pain, Lembke said.

“Whether it’s surgery or women going into childbirth, there’s an alarmist reaction to pain, and it’s contagious and makes more people anxious, which makes the pain worse,” she said. “We’re terrified to experience pain.”


Those who experience chronic pain say these views embolden clinicians, pharmacists, and others to treat them like addicts and criminals.

Hemberry, a 36-year-old multimedia specialist in Leavenworth, Wash., suffers from a connective-tissue disorder called Ehlers-Danlos syndrome and trigeminal neuralgia, an often-excruciating nerve condition for which she occasionally takes opioids.

She heard Lembke interviewed on NPR recently and was bereft. “Every pain patient is now an addict and a failure,” Hemberry said.

Last March, the Centers for Disease Control and Prevention issued guidelines for opioid prescriptions. Those guidelines focused on addiction prevention, opioid trafficking, and medication diversion, and included stern cautions against using the drugs for chronic pain.

To Hemberry, the guidelines seemed reasonable. “But many doctors and administrators have taken a hard-line ‘no opiate’ stance,” she said, and go to absurd lengths to enforce it.

“What people forget is, those who end up on opioid pain management have usually tried everything else unsuccessfully.”


Earlier this winter, Hemberry recalled, she went to the emergency room with a migraine headache, a frequent symptom of her medical conditions. She was seeking a saline drip — one of the few treatments that has helped her pain — and said she wasn’t seeking opioids.

The nursing staff nonetheless grilled her on her medications and chided her for taking too many pills, even though her daily medications are non-narcotic. She turned her head at one point and started sobbing.

Others report a similar lack of empathy.

“What people forget is, those who end up on opioid pain management have usually tried everything else unsuccessfully,” said Yacoe, 61, who suffers from chronic migraines. “I stayed away from opioids for decades. It was really and truly a last resort.”


Some clinicians trace the early roots of the opioid crisis not to the pharmaceutical industry’s marketing of controlled-release morphine pills, but to a 1986 study of 38 non-cancer patients performed by palliative care doctors at Memorial Sloan Kettering Cancer Center.

Most were treated with oxycodone, methadone, or levorphanol in small daily doses — less than half the surgeon general’s current recommended starting dose — and 24 reported acceptable or adequate pain relief, while two patients developed “management” problems with the drugs. (Both had histories of substance abuse.)

According to Carr, of the American Academy of Pain Medicine, the conservative opioid treatment approach used in the study, and the modest benefits reported, reflect the current practices and expectations of many doctors.

But a growing number, he said, are being pressured into a zero-tolerance policy.

“Because if one isn’t anti-opioid enough, there’ll be protests,” said Carr, who is also founding director of Tufts University’s Pain Research, Education, and Policy Program.

Other experts note that, as opioid restrictions tighten, the medical system and insurance industry have done little to support opioid-withdrawal efforts, help more physicians learn how to help patients manage pain, or enable access to alternative therapies.

In some cases, patients seeking to treat their pain have turned to street drugs like heroin or synthetic fentanyl, while others have instead chosen suicide. (In one high-profile case recently, a man who committed suicide left behind notes saying he could find no help for his chronic pain; at least two of the roughly 20 patients interviewed for this article said they had considered suicide because of their pain.)

Everyone wants the number of opioid overdoses to fall. But patients like Tausig don’t want to be made to suffer.

Tausig, a single father of two teens, said that every month he needs to fill a prescription, he’s fearful it will be denied.

Whenever he thinks he might meet with a new pharmacist or clinician, he dresses neatly to hide his tattoos. He said he thinks they can cause people to rush to judgment or even stigmatize him as an addict.

“You’ve got the wars on the medical side, but then you’ve got the governmental people stepping in, who have no idea,” Tausig said. “All they know is drugs: bad.

“They don’t see a struggling single dad in the most expensive place in the US who’s just trying to get through the day.”

[tod evans]

When Dr.'s and patients get fed up they'll start going after the politicians.

Problem is how many must suffer in the mean time?

Better 10,000 junkies OD than one grandma suffer needlessly!

Get government out of the drug business.

[shakey1]

... add to that, yet more goobermint shenanigans...

Recent efforts by state and federal lawmakers aimed at punishing drug traffickers could wind up sending people to prison simply for seeking pain relief, according to critics.
This week the American Kratom Association (AKA) sent an action alert to members warning that a bill introduced by Sen. Chuck Grassley and Sen. Dianne Feinstein could be a “backdoor way” of banning kratom -- an herbal supplement that millions of people use as an alternative to opioid painkillers.

The “Stop the Importation and Trafficking of Synthetic Analogues Act of 2017” – also known as the SITSA Act – would give the Attorney General the power to list as a “Schedule A” substance any unregulated drug that has a chemical structure similar to that of a drug already listed as a controlled substance. A similar measure has been introduced in the House.

The bills are ostensibly aimed at banning chemical cousins or “analogues” of fentanyl, a powerful synthetic opioid blamed for thousands of
overdose deaths that is increasingly appearing on the black market.

But kratom supporters fear the SITSA Act could also be used to ban kratom, something the Drug Enforcement Administration tried unsuccessfully to do last year, claiming it was an "opioid substance" with “a high potential for abuse.” Kratom is not an opioid, but it has opioid-like properties that reduce pain or act as a stimulant or depressant – much like a controlled substance.

“So now the anti-kratom bureaucrats in Washington want to ban kratom simply by claiming it has the same effects as an opioid – calling it an ‘analogue’ of the opioid,” said Susan Ash, the AKA’s founder and spokesperson. “After everything that we’ve fought successfully against and endured together as a movement, our lobbyists are concerned that this is now the perfect storm for banning kratom.”

https://www.painnewsnetwork.org/stor...-pain-patients