The HEAL Initiative (Helping End Addiction Long Term) is one of the rare NIH initiatives that presents real possibilities for a long neglected population. It took an act of Congress – which gave the NIH $500 million and specifically directed them to use it attack the opioid issue – to get the NIH to move on chronic pain. HEAL, then, is clearly a response to political pressure but it’s a political response with a difference.
Like the NIH does it took a good amount of time (a year) to develop the plan and it appears to be a good one. The Initiative could have focused purely on better detection of people abusing opioids and finding better ways to get people off of opioids, but it went further. It’s actually going to help with chronic pain too.
The NIH has had ample reason to act years ago but it appears to take Congressional appropriations to act meaningfully on symptoms like pain and fatigue. (It does diseases (except for pain and fatigue diseases) much better.
The 2011 Institute of Medicine Report on Relieving Pain in America estimated that acute and chronic pain cost the U.S. about 600 billion dollars a year. That report came about only because some smart Senator or Congressman mandated its publication with a provision in the Affordable Care Act that required the Department of Health and Human Services to enter into an agreement with the IOM “to increase the recognition of pain as a significant public health problem in the United States.”
The IOM made good on its promise – it documented the startling pain needs in the U.S., and provided a blueprint for moving forward to finally give pain its due. That done, the NIH essentially did the same thing with pain that it does with fatigue – basically nothing.
In 2016, pain advocates tried again with a federally produced National Pain Strategy, which again produced no major initiatives. Now the opioid crisis has finally prompted the NIH to get to work.
Now that the NIH has the money, though, it appears to be using it well. The bigger problem behind the opioid overuse is the lack of better pain drugs, and the bigger problem behind the lack of drugs is the lack of knowledge of how pain occurs. Francis Collins, the Director of the NIH, appears to get it. Fierce Healthcare reported that Collins, at a recent NIH meeting on chronic pain and the opioid crisis, said the healthcare system is grappling with a “joint crisis of pain and addiction”.
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“I think all of us that are concerned about this worry sometimes that we talk about one without realizing the other requires intense attention. But what about the people with chronic pain—24 million of them—with daily pain? What are they supposed to have available? We all agree opioids are not a great solution. But what other solutions do we have for people with severe daily pain? Not nearly enough.”
Instead of providing a stopgap solution to a political issue, the NIH in its HEAL Initiative is going to tackle both of those two big problems: it’s going to increase funding for pain drug trials; and it’s going to plow more money into pain research. NINDS just released a more detailed report on what the HEAL Initiative will do in the Journal of the American Medical Association (JAMA).
The first part of the Initiative will focus on reducing opioid overuse. The second part will focus on understanding more about pain itself and developing more treatments. It will:
- Use brain scans, “omics” (gene expression, protein expression, etc.), sensory testing, and psychosocial assessments to try to identify individuals at risk for developing chronic pain. This is a process that has begun with underway with regards to brain scans (see below) but needs more work elsewhere. The optimum result would, of course, be a blood test which could identify individuals whose nervous system’s are primed to go bananas after an injury, or a serious of injuries, or an infection.
- Fund the search for novel targets for small molecules, biologics, natural products, and devices that will reduce pain. The pharmaceutical industry’s reluctance to try and develop pain drugs, despite the enormous potential payout, reflects the complex and varied nature of the pain production process in humans. If the feds can identify precise targets for pain drugs, pharma should be more inclined to develop drugs for them.
- Develop animal models for a variety of human pain conditions. (Could fibromyalgia be one of them?)
Sidebar: Chronic Pain Waiting to Happen
Studies suggest that some people are chronic pain waiting to happen. One study which scanned people’s brains just after they came down with low back pain and then a year later was able to predict with astonishing effectiveness who would come down with chronic back pain. White matter changes occurring in four parts of the brain (prefrontal cortex (PFC), accumbens, amygdala, and hippocampus) prior to or during the early stages of the injury were able to predict 80% of those who would come down with long term back pain.
The authors believed that genetics might be able to explain 70-90% of the white matter changes seen. The diseases in which similar white matter changes have been found included fibromyalgia and several diseases associated with it including fibromyalgia, temporal mandibular disorders, headache and IBS.
The HEAL Initiative will look much, much deeper in an attempt to find the “switch” or set of changes which reset the pain “volume control” in the brain and elsewhere. If it can identify how that switch is triggered it may be possible to create drugs that turn it off.
By reducing the upfront economic burden for preclinical screening, the program will incentivize the discovery of non-addicting therapies, and generate rigorous, high quality data within a pipeline of novel non-opioid and non-addictive therapies. Heal Initiative
- The NIH will create not just one but a variety of animal models that mimic different pain states and then use those animal models to test the effectiveness of a variety of drugs.
- The NIH will also create new human-based screening platforms that more closely approximate human physiology of pain and addiction than those currently-available. Both of these first two steps are “infrastructure steps” designed to more cheaply and effective test pain drugs.
- In collaboration with drug companies, academia and the FDA, the NIH will evaluate potential drugs in order to accelerate the development of effective treatments i.e. the NIH is going to assess drug possibilities that are not being currently assessed and then pass its assessments onto drug companies in hopes it will prompt them to move on them.
- It will boost that effort by creating a new clinical network designed to speed up testing and reduce costs.
- Those networks will operate in a hub-and-spoke manner to ensure consistency, and to streamline the approval process and patient recruitment. Given the huge costs of clinical trials, this network could be a major step forward and perhaps provide a model for other illnesses.
We know that the future of pain treatment does not lie in opioids – at least those opioids we have now. The HEAL Initiative will hopefully open up brand new possibilities for treating pain. Here are some possibilities under investigation now.
- Will Ketamine be the Next Big Thing for Pain, Depression (and Fatigue)?
- The Surge Protectors: the Next Big Thing in Pain Drugs?
- Taking the Sting out of Pain: Scorpion Venom Could Provide Alternative to Narcotic Pain Drugs
- Relief at Last? The Next Generation of Opioid Drugs, Fibromyalgia and Chronic Pain
- The Next Generation of Fibromyalgia Treatments – The Clinical Trials
- Vagus Nerve Stimulation, Fibromyalgia and Chronic Fatigue Syndrome (ME/CFS)
More to come
Further resources will be devoted to how to prevent chronic pain, precision medicine approaches to pain, and non-drug approaches to pain management. This summer, we’ll find out the answer to the big question of how much funding the NIH will devote to understanding pain and clinical trials as the HEAL funding opportunities roll out.
The big question is how fibromyalgia and ME/CFS will fare. It’s hard to imagine that any deep dive into pain won’t benefit these diseases. The chronic pain in FM is similar to the pain in other diseases in that it’s chronic and involves some sort of pain system reset. It’s different, though, in that it’s more widespread, is not identified with an injury, and also includes problems with sleep, cognition, fatigue and stimuli.
The big question is whether fibromyalgia will be explicitly involved. Certainly one would think the most commonly treated rheumatological disorder would get some attention as the NIH ramps up its first big attempt at tackling pain. (A fibromyalgia mouse model would be a great first step).
The NIH has been mostly ignoring FM up until now and FM is ensconced in an Institute (The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)) which seems to think that it’s mainly a behavioral disorder.
On the other hand, FM is the purest pain disorder known – no swelling or injury is involved – it’s simply pain amplified, and one would think and hope a major initiative committed to understanding pain would naturally target it. Now might be a good time for FM advocates, if they haven’t, to push for grants which specifically mention FM. The first research grants for the Heal Initiative will be announced soon.
Any idea who to contact to advocate for attention to fibromyalgia, specifically? Thank you!
I’m afraid I don’t. I worry, actually, that the time has passed. The NIH reached out to a variety of patient, advocates, academicians, and drug companies as it prepared the initiative over the past year. Whether it reached out to people associated with FM (patients, advocates, researchers) I don’t know.
It will be putting out specific grant opportunities over the summer. Once we see those we’ll see how much money of the $500 million the NIH is devoting to understanding pain and developing new treatments and what specifically it will be providing funds for.
Lol. Nih loat my comments to the fprs. Theyre opposed to curing and prwventing pain. I adcocated for such in the nps. All of 0 i repeat 0 dollars were spent on the nps in 2017. Its remarkable you believe the same ol boy network of morally anesthetized market fundamentalists at nih care or have the capacity to do anything but serve academic capitalism and bullshit the public.
How do they know that no swelling with fibro is involved? Either fibro or ME/CFS with it’s flare up’s of joint pain does indeed cause swelling in me. Just not measurable with the kinds of blood tests they currently have on hand. The swelling/inflammation was found to go away upon the joint pain flare up resolving. They need to find a new method that can detect the type of inflammation from which we do suffer.
Opioids might not be the first line of defense to pain sufferers but it’s definitely way more helpful than they let on. I can’t take NSAIDS or oral steroids. Where would that leave me? I’m also hesitant on taking new medications due to multiple chemical sensitivities and my opioids work just fine. They’ve over demonized them and scared off many who are dropping patients who need this medication. It’s not a want for us. The crisis should never include looking at illegal drugs like heroin when getting the real statistics with opioids.
Yes, there is swelling sometimes with FM but the swelling and the inflammation associated with it is clearly not the primary cause of the pain as it is in diseases like rheumatoid arthritis. While your local pain may have gotten better my guess is that you experience pain in other parts of your body in which you don’t have pain (????)
As Dr. Clauw noted there’s nothing the matter with opioids when they work – and you are somebody they work for. There’s nothing the matter with taking opioids in general for flareups either. The concern is over people for who are taking them consistently and are still have high amounts of pain.
The goal of HEAL is to provide new treatments that work better. Let’s hope that you and others will have new options in the future.
Lol. Youre another true believer in scientism and the iron triangle and you dont want to see the truth that nih and their affiliates lack the analytic capacity the representational capacity the motivational intensity and skin in the game to make pain care much different or better. Hey cort where are all those new fda approved treatments for fibro lupus lyme mecfs.. I rest my case.
I agree with Diane McKay. I know I have widespread inflammation, and sometimes it is visible, but not typically. It doesn’t show up on standard blood tests, but that doesn’t mean it isn’t there, in our bodies. There are other tests showing an activated immune system which is a marker for inflammation, but rheumatologists don’t do those tests. The biggest problem is that doctors aren’t paid to be curious, solve mysteries, find solutions, or even talk to other specialties. They are paid to go through a checklist and prescribe as many medications as can possibly be supported by their tests. They only have 2 minutes to do this, as a result of the insurance industry and the government management of health care. Anomalies are of necessity ignored, there is no time to pursue them. No wonder we are all in chronic pain.
The NIH has a record of using funds specifically appropriated for ME/CFS for other purposes, and they have done damn little for us since then in spite of empty promises. Nor have they ever returned the money they stole from us. I’m not sure what basis you have for such confidence in them.
It would be so much more powerful to eliminate chronic pain by eliminating chronic disease (funding Cortene, for example), rather than creating new industries whose profits will be entirely dependent on continuing chronic illness.
So they’re only looking at drugs?
What about acupuncture, prolotherapy, prolozone, platelet rich plasma, and stem cells? Admittedly, they wont solve every pain issue, but for the problems they work for, they can be quite effective.
Right. My sense is that they were mostly looking at drugs but also brain stimulation and probably others. The NIH has launched a new initiative to learn how to stimulate the peripheral nervous system effectively. I imagine that acupuncture and other similar practices would fall into that. Unfortunately I can’t remember the name of the initiative off the top of my head.
Ha! the NIH Initiative is called SPARC and you can read about it in a Health Rising blog here – https://www.healthrising.org/blog/2017/01/02/electroceutical-revolution-fibromyalgia-chronic-fatigue-syndrome/
Lol. Once again your faith in underpowered researchers whose poor judgment and decisionmak8ng defined the opioid hysteria is on display. Your failure to call for new staff at nih of much higher caliber stands in thevway of progress. Prove me wrong. And btw you dodnt call for curing pain in the nps. I called for curing pain. Wake up.
I was injured in 5 car accidents in 10 years. I was healthy and powerful with a recent degree in science. I re learned how to walk, talk and wore a hard neckbrace. Swelling everywhete pain 13/10 or much worse. Now I am bedridden with a tilt powerchair. My longest continuous vomiting diahrea was 26 days and nights. Acupuncture and qi gong saved me. Spray and stretch helped headaches. I tried a science masters in fieldwork on climate, habitat and beaver. Contracted giardia fever 106 celsius in hospital. Lost the degree. Science depends on the integrity of the researcher and their funding. I studied cognitive behavioural therapy and psychosocial researchers. Then I studied leadership develpment, workplace learning and created ideas and needs for collaborations of all parties. The findings are in my papers and thesis. We collaborate poorly when patents are our objective to make money for any one organization. I worked in research for my government but refused to sign legalese loyalty. A researcher in Sedmonton refused to remove pieces of valid data for her new boss whom had questionable ethics and had replaced the initial lead whom also refused to remove data. It went to court and the woman won. Psycho social leaders when researched leave valuable clues to their work in their past journal papers and in their past and present roles in companies and directorships. Follow the money and the documents supporting their theories. Interview your healthcare providers based on their past funding and presentations. I think too much research is done in labs and we need to research our real worlds. I want to do a doctorate from my bed cuz thats where I am. Two of us will be gathering our ideas and creating with our communities some way of being whom we are. She is amazing.
Since CBD/THC for medical use is not legal federally, it sadly won’t be part of the study…….very sad. I wonder if Trump will come through with his pledge to make medical marijuana legal at the federal level and do so quickly so that federal money can be used to study it.
CBD and THC legal or not, have been hugely beneficial for me. No more opioids with their inherent side effects and good sleep have been life-changing.I’m almost back to being human….
Unfortunately and perhaps not surprisingly the Trump administration has done exactly the opposite. The Obama adminstration relaxed restrictions on federal marijuana production for research and as soon as Trump and Sessions came in they blocked that – so cannabis research is stymied again.
Trump and Sessions also clawed back a key regulation which stated that so long as states did certain things to ensure safer marijuana use they would not go after states that made medical marijuana legal. Now federal prosecutors have the leeway to go after any marijuana production or selling – legal or not – anywhere in the U.S. I don’t know if they’re using that authority but they now have it.
Trump’s choice for attorney general – Sessions – has long been on the far, far right regarding marijuana and other issues. He was a fringe character until Trump put him in charge of the federal judiciary.
My opinion is that Trump and Sessions and their entire administration (almost) are all people with hammers, and everything they see is a nail. It’s really a shame.
But on this topic, and Cort, maybe you’ve talked about this and I just haven’t seen it, here’s an easy to understand article explaining the exact moment the body detects acute pain: “After an injury that leads to pain, the neurons (nerve cells) that detect threats to the body, such as dangerous chemicals or excessive heat, “remember” the pain. Such neurons (known as nociceptors) do so by making new proteins. The formation of a so-called pain memory—also called pain sensitization—occurs so that proper steps are taken to protect the injury and allow it to fully heal.” And it goes on from there.
But what’s really interesting the rest of the article. “…researchers have designed a new molecule, called Poly(A) SPOT-ON, that stops creation of the proteins that neurons need to become sensitized to pain following an injury.” It’s pretty cool, in my estimation. It’s worth reading, and not long. However, like most things researchers come up with, the positive results they got were on mice, and who knows how long it may take to transfer that outcome to humans, if at all. Here’s the link:
Thanks Judith! 🙂
I think what makes our individual doctors crazy, is that no one drug works for all of us. I have ME/CFS/FMS, plus a herd of other illnesses. Multiple Chemical Sensitivities, NASH (non-alcoholic steatohepatitis (caused by too many doctors prescribing pain meds, all of which were buffered with Tylenol!) damage to my spine, (gift of three drunk drivers in 10 years. Driving in California and Hawaii is an ADVENTURE!) Hypothyroidism, Degenerative disc disease (drunk drivers), and now, I am to be evaluated for MS!
I became ill in June 1981. Husband left after a year, I kept struggling to work for 9 more years, finally left my aerospace job by ambulance for the SEVENTH time. Good thing I had Long Term Disability. As for the possibility the disease will shorten your life? I just turned 80! I cannot take most opioid drugs, with the exception of Demerol. I take that ONLY when I am having a migraine. I take Xanax for sleep, and have for decades. And I take it ONLY at bedtime. I add a bit of melatonin to help. I also have IBS – the fast forward kind. I found a way to control it. Take Lomotil first thing when I get up. Don’t eat for 2 hours. After that, I am fine. It took 25 years of me yelling at doctors to do more than the basic TSH test for hypothyroidism. Finally, I was correctly diagnosed, and now take a thyroid replacement. Surprisingly, it dropped my pain level a bit. Yesterday, I drove 162 miles round trip to see a certain doctor, and I am wiped out today. But at least know WHY I am wiped out. A few days’ rest will take care of that. So, I have found ways to deal with it. There are things I can no longer do, so I write, read, watch TV, and a few days a week, I go to our local 84-degree ‘swimmin’ hole, for the only exercise I can do that does not hurt. I am also a former SCUBA diver. So swimming is wonderful.
NOW: I have information about a drug that could stop the drug epidemic. I’ve researched it, it’s real, and it works. The drug is called IBOGAIN. An Addict is in a hospital, drug is administered, and UNDER CONSTANT MEDICAL OBSERVATION, the drug addict wakes up, no cravings, or no need to get drugs in order not to get ‘dope sick’ – where they have to get the dope, to prevent the painful and awful withdrawal symptoms. A cure, in 24 hours. I have told the mayors of 5 major cities about it. Nothing. it is illegal in the United States, because it causes ‘hallucinations.’ Well, in the treatment protocol, the hallucinations are what the body does to relive the experiences, and help the addict! I guess a really dedicated idiot might need two treatments. Especially those for whom Methamphetamine was the drug of choice. It even works on tobacco and alcohol. Don’t believe me, the drug is listed on the ‘Net. Do your own research. There are treatment centers in Mexico and Canada. It is expensive, about $7500, but what is the cost of a life? It costs $35,000 a year to keep a prisoner in jail or prison. Young, first time offenders emerge from there, traumatized, and crazy.
Also, with all the controversy about legalizing marijuana, there is a component of marijuana, called CBD, that stops seizures in children, and may hold promise for people with ME/CFS/FMS, and even MS. It does NOT cause a person to get high. It also holds promise to reduce pain. Trust me, nobody hates illegal druggies or persons who abuse their medications, more than I do. But if my doctor approves it, and only if he does, I would try it. I don’t drink, smoke, do drugs, abuse my medications, heck, I’ve even given up driving at night. Those new terribly bright headlights make it more dangerous than I want to risk. But after being so ill for 37+ years, I am willing to try. But only under my doctor’s care. Best wishes to you all, and with endless hope for either a cure, or at least, a better treatment. One joke about how to diagnose our illness:
If the doctor is not exhausted by the end of the visit, the patient doesn’t have it!
New lab test for ME/CFS 84% accurate.
sorry: will have to paste, link did not go thru
A huge part of the problem for those of us with chronic pain: Andrew Kolodny and PROP, Shatterproof, THE Rummler group, and all the other anti-opioid zealots that make getting proper pain care harder each day!