Pain patients getting new attention from top at FDA 

Chronic pain patients, overlooked in opioid crisis, getting new attention from top at FDA – by , USA TODAY (mainstream national media!)

Chronic pain patients and the groups that represent them say the escalating government response to opioid addiction ignores their need for the painkillers and doctors who will prescribe them, leaving some out of work, bedridden and even suicidal.

Tough state laws on prescribing that took effect Sunday, Centers for Disease Control and Prevention (CDC) dosage guidelines and state and federal charges against doctors who prescribe opioids are an overreaction to addiction, according to several dozen people with unremitting pain who contacted USA TODAY.  

Because of inaccurate tracking methods, the CDC said it incorrectly counted many overdoses from illicitly manufactured synthetic opioids such as fentanyl as prescription drug deaths.

The CDC had estimated 32,445 Americans died from overdoses involving prescription opioid pain medication in 2016.

The CDC’s new estimate of fatal overdoses
from prescription opioids is

17,087, or 53% of the original estimate

That’s about half. Our own CDC made a “mistake” and doubled the numbers of overdoses from prescription opioids…

a “mistake” that misled other government agencies and most government officials up to the president,

a “mistake” that sent legislators, regulators, and even doctors to attack the wrong target (patients taking opioids for pain),

a “mistake” that misguided millions of dollars of taxpayer funds,

a “mistake” that caused tens of thousands of pain patients to be denied their pain relievers.

A simple “oops” just won’t suffice for this magnitude of “error”.

Even though state laws say chronic pain patients who need medication will receive it, “that’s not what’s happening,” says Lauren Deluca of Worcester, Massachusetts, who founded the Chronic Illness Advocacy & Awareness Group last year after her own challenges getting the opioid painkillers she needed.

Once again, proof that only those that “know” chronic pain can understand it.

The Food and Drug Administration (FDA) is trying to undo some of the damage through a host of actions that include a public meeting July 9 on chronic pain drug development and the challenges pain patients face in getting the treatment they need.

DEA Miami Field Division Deputy Special Agent in Charge Jaime Camacho said last week that the agency is “committed to ending the opioid crisis that continues to plague Florida and endanger the welfare of our communities.”

So, the FDA has recognized the gross maltreatment of pain patients, yet the DEA still proudly hews to their misguided prohibitionist policies.

Once we let the primitive and outdated law enforcement mentality of the DEA into doctors’ offices, patients were bound to suffer. The DEA has no knowledge of or interest in the medically appropriate treatment of intractable chronic pain.

With their constricted worldview focused on prosecutions, arrests, and dramatic raids of drug dealers, the DEA sees everything in black and white. Their limited understanding can only grasp that “opioids are bad”; the DEA cannot comprehend the difference between legally prescribed pain medication and injected street drugs.  

Clinical psychologist Michael Schatman, editor in chief of the Journal of Pain Research, who describes himself as an “opioid moderatist,” said about 90 percent of people are better off without opioids.

But it’s the 10 percent who need them that are terribly harmed by policy and enforcement actions pushed by groups he said are “radically anti-opioids.”

“For years, federal and state legislators did nothing, leaving it up to state medical boards and the regulatory agencies, which was the problem,” said Schatman, research director at Boston Pain Care, which has treated hundreds of patients without an overdose or suicide.

At first, I thought the 90% figure was completely wrong…
until I gave it some further thought.

This number is coming from a doctor down in the trenches, a nationally known and respected doctor who is absolutely not anti-opioid. He would certainly have a better overview of the “pain crisis” than we individual patients ever can.

If his experience is that 90% of the pain patients he sees don’t need opioids, that means they don’t have the same kind of pain we advocates suffer from, pain that makes you desperate and suicidal without relief. So, for now, I’ll go along with 90/10 assumption.

That ratio would explain why only such a small proportion of people in pain in America are vocal and advocating. 

It would explain why there is still so much pressure to reduce prescribing if 90% could be getting opioids they don’t need.

But we only hear about and notice the 10-percenters. Those might be the only ones for whom tapering is a disaster, while the 90% who didn’t need opioids may have been tapered without much trouble and remained silent.

And *we* are the 10-percenters, the ones who absolutely need opioids and use them responsibly and aren’t addicted. We are the ones that suffer when subjected to indiscriminate and arbitrary tapering of our lifesaving medication.

“Now all of a sudden, state legislators are passing incredibly draconian laws that are and have the future potential to literally kill people.

That attitude has led some doctors whose patients have had no problems with opioid prescriptions to back away from prescribing them. Schatman said there’s a big difference between depending on opioids to survive and becoming addicted to them.

Making matters worse for what’s estimated to be millions of patients, the Centers for Medicare and Medicaid Services plans to drop coverage of opioid medications above a certain dosage starting next year.

Elsewhere at the Department of Health and Human Services, the FDA’s plans include encouraging medical device development for pain and hosting a drug development meeting July 9 that focuses on how hard it is for patients with chronic pain to get treatment and what solutions exist.

“The reality is that the opioid drugs work for certain patients, and there are certain situations where the opioids are the only drugs that work for those patients,” FDA Commissioner Scott Gottlieb said.

The FDA’s success will be tested by the fact that physicians are largely policed by states and that even as opioid prescriptions go down, overdose deaths increase as many suffering from addiction have moved on to heroin, often in combination with other drugs.

The FDA recommended that doctors reduce opioid prescriptions, but doctors and their medical societies remain opposed.

Chronic pain patients across the country said that when physicians lose their license or stop treating pain patients, it can be difficult, if not impossible, to find a new doctor willing to take them on as a patient.

In Virginia, then-Governor Terry McAuliffe boasted on a panel in October that the state led the nation in reductions in opioid prescribing, including a drop of a third in the prior six months. Doctors aren’t allowed to prescribe or refill a prescription for opioids for longer than 10 days without a written explanation.

It’s medically unsound to establish treatment guidelines based only on cumulative milligrams of a medication prescribed by a single doctor while ignoring the individual patient outcomes.

It seems like it would be malpractice when a patient is taking a medicine that’s been effective for relieving the primary disabling symptom (pain) of their incurable medical condition (chronic pain) and suddenly their doctor stops prescribing that medicine for administrative reasons (“guidelines” from above) completely unrelated to the patient’s benefit.

And this is what’s happening when doctors are punished (by bosses, by boards, even by legislation) for prescribing “too many” milligrams of opioids (“too many” means more than other doctors, averaged over all specialties).

To help remedy this, the FDA is considering encouraging medical professional societies to develop evidence-based guidelines on appropriate prescribing and the possibility of incorporating new prescribing information on opioid painkiller labels.

Isn’t this exactly what the CDC had supposedly done with their Opioid Prescribing Guideline?

Again, more guidelines lead to more standardization, not taking into account an individual’s specific pain and responses to medication.

Not all chronic pain is the same, yet all guidelines treat it as a single entity.

Schatman is skeptical the efforts will make much difference, in part because he said “there’s no empirical evidence that apps and other ‘medical devices’ can improve the quality of pain medicine in the United States.”

Online, I’ve noticed that all articles about opioids or pain treatment are surrounded and overload with ads for “recovery centers”.

These are just like the fabled “pain management programs” that you go to hoping to get better control over your pain, but they are actually opioid recovery programs in disguise. See previous post about my experience: Effective Opioids Declared Ineffective.

“The opioid pendulum has swung awry,” Schatman said.

“This current climate of opiophobia is … leaving patients more dysfunctional, with diminished quality of lives, severe hopelessness and increasing suicidality in the chronic pain patient population.”

That neatly sums it up the plight of those 10% of pain patients for whom opioids are literally life-saving.

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6 thoughts on “Pain patients getting new attention from top at FDA 

  1. Mom's Chronic Ride

    No offense, but I don’t think most people even know that the FDA was holding a “Meeting” to hear from patients and doctors on the #opioidcrisis… especially, at least, not until recently.

    It’s not like there’s been a public service announcement played repeatedly to make sure everyone has a chance to comment on the site–which is probably why #SuicideDue2Pain is still happening… I’m guessing those victims had no idea there was a chance to stop this insanity.

    In my opinion, the 800 responses on that site (thus far) should be held as a small example of how much pain Americans are in; because getting these responses in such a short time–without properly advertising this meeting to the public–is pretty darn impressive if you ask me!

    And, by the way, I’m guessing the idea that “90%” of patients apparently don’t need opioids is wrong too… Those kind of numbers only come from anti-Opioid zealots that would be the first to scream for pain relief when they end up in the hospital.

    The agenda seems pretty clear… The FDA has been streamlining more expensive, unproven, even deadly new drugs on the market in an attempt to make opioids invisible and obsolete. It seems to me that the bottom line, as usual, is more important than human lives.

    Give us pain warriors a chance though… It’s not over yet. Besides, the meeting might be coming up, but written comments will still be accepted until September from what I understood.

    I hope you told your story? I sure have. ❤️

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      When the 90% number is coming from a doctor that has been fighting for pain patients’ right to opioids and is clearly “on our side” I’m willing to believe him until proven wrong.

      We hear about the vast numbers of Americans living with chronic pain, yet there are so few actually advocating for their rights that it seems to imply only 10% need opioids enough to fight for them.

      So, as shocked as I initially was by his estimate, it would sure explain why so few pain patients are pushing back against what’s being done to us. I had actually begun suspecting the same thing myself (but not 90%!).

      Liked by 1 person

      Reply
      1. Mom's Chronic Ride

        I think I just want to give people a chance, that’s all. Unless they are actually lying to their doctors, I would assume that they need them. I’m not going to argue the numbers though, because we all honestly don’t know what they truly are.

        I’m more concerned about people that need them to have QOL due to chronic pain–or after a surgery, or even a CPP that goes to the ER because of uncontrolled breakthrough pain. No one should have to suffer because of the opinions of a few.

        Liked by 1 person

        Reply
        1. Zyp Czyk Post author

          Absolutely! We can never know what someone else feels and, until we do, we have to take their word for it. I think the lack of an objective measurement is the main problem with pain – it’s impossible even to prove it exists.

          But arbitrarily denying us relief just because we cannot prove our pain is inhumane and even a human rights violation: https://edsinfo.wordpress.com/2018/03/16/human-rights-watch-investigating-u-s-pain-treatment/

          Liked by 1 person

          Reply
          1. Mom's Chronic Ride

            I can’t agree with you more. My life was full before pain and other symptoms took over my life. I have been called every name by some doctors because they couldn’t see my pain and symptoms… a lot of symptoms are taken by word, not sight… pain happens to be one of them.

            Liked by 1 person

            Reply
  2. Pingback: Tapering Long-term Opioid Therapy in Chronic Pain | EDS and Chronic Pain News & Info

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