FDA Incentivizing Pharma to Develop Less Abusable Pain Medicines

FDA Incentivizing Pharma to Develop Less Abusable Pain Medicines

FDA and Pharma commit to balanced solutions to curb addiction, treat pain.

By: Sidney H. Schnoll, MD, PhD and Jack Henningfield, PhD

With opioid abuse and misuse continuing to be a public health problem in the U.S., there is an urgent need for balanced, commonsense solutions to address this ongoing public health problem without abandoning those who legitimately need pain relief. Since 1999, the rate of opioid-related overdose deaths has quadrupled in the U.S., resulting in the deaths of more than 70 people per day as reported by the Centers for Disease Control and Prevention in its “Data Overview: Overview of an epidemic” report. Yet, there are still those – 38 million Americans – who need strong pain relievers, such as opioids, to ease their debilitating chronic pain so they can work, care for their families, and live a normal life, less compromised by pain.

The heightened media, political and public attention on the issue often distorts the facts, which has made it easy to blame one side or the other, but a balanced approach is critical and a collective understanding that something needs to change is undeniable (Scholten and Henningfield, 2015, 2016). This has been the approach of the World Health Organization in its efforts to ensure appropriate access to opioid analgesics to relieve pain while balancing controls to reduce the risks of abuse and diversion.

In addition to the World Health Organizationcollective efforts are also needed from organizations like the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the pharmaceutical industry, as well as physicians, patients, family members, non-profit organizations and others.

One important approach is creating medicines that provide pain relief while reducing the potential for abuse. FDA has been instrumental in supporting the development of abuse deterrent medicines at the same time that many science-based research and development companies are investing in such innovations. The commitment to developing abuse deterrent, chronic pain medicines is an important step towards reducing abuse of prescription opioids.

ONE MASSIVE PROBLEM, MANY PARTS

Of the many components to the opioid abuse epidemic, there are two distinct issues concerning FDA and pharma, and at the same time driving innovative solutions.

The first is the abuse of prescription pain relievers by those who were never given a prescription. From the National Survey on Drug Use and Health, an estimated 70 percent of Americans who have reported using opioids non-medically admitted they obtained the drug for free from friends or family members, or through theft or purchase.

Many of the reported deaths from overdoses occur in individuals who never received a prescription for opioids, and frequently involve multiple drugs. Of those who have received prescriptions, many have histories of abuse of drugs prior to getting the prescription and once again, often involve multiple drugs.

The second part is the issue of individual pain management. Today, more than 100 million Americans are dealing with some form of chronic pain. The consequences of inadequately treated pain include decreases in the ability to work and participate in social activities, and overall reductions in quality of life. All too frequently, people with chronic pain seek out illicit opioids when prescription relief is difficult to access, and suicide occurs too frequently when pain relief is unavailable. While there are alternative solutions such as physical therapy and over-the-counter medications (like ibuprofen) that can help, management of pain needs to be tailored to the individual.

FDA is attempting to incentivize pharma to look farther and more innovatively toward solutions that will help pain sufferers, while reducing the likelihood of abuse. FDA’s 2015 “Guidance to Industry on Abuse Deterrent Opioids” implies a stick and carrot approach. The stick is tougher criteria for evaluating the abuse potential of opioids, and presumably for their approval with increased evaluation by external expert advisory committees. The carrot is the potential for labeling that acknowledges some level of abuse deterrence as supported by extensive evidence. Although not a focus of this article, developing approaches to this problem must include not only the development of safer pain medications, but to ensure appropriate availability of treatment for those who suffer from a substance use disorder.

PROGRESS IS MADE FARTHER WITH TEAMS

For years, the FDA has taken a positive and collaborative approach to encourage pharmaceutical companies to continue researching and developing alternative solutions to today’s opioids. As a result, six abuse deterrent formulation medications have been approved by the FDA. These select therapies may reduce some methods of abuse, and still provide pain relief. As the FDA has provided guidance and incentives to approve new, less addictive medications for pain management, biotech companies focused in the space continue to innovate and invest in the development of new reduced-abuse therapies.

Today, many companies working to provide patients an alternative pain relief method utilizing next-generation solutions – such as Collegium Pharmaceutical, Inc., Depomed, Inc., Egalet Corporation, Nektar Therapeutics, Pfizer, Inc., Purdue Pharma and Sanofi. These “next-generation” solutions are looking to stem abuse with new, abuse deterrent formulations and new chemical entities that mitigate the risk of abuse. Nektar Therapeutics, for example, created an entirely new opioid molecule specifically designed to enter the brain much more slowly so as not to trigger a rapid “dopamine rush” or “high” sensation, while still acting on the receptors that relieve pain in the body. Solutions such as Nektar’s are another step closer to providing patients in need of chronic pain relief, at the same time reducing the want and need for patients to abuse opioid therapies.

LONG WAY TO GO, BUT WE’RE GETTING CLOSER

In reality, innovation takes time, and a solid solution will not happen overnight. The College on Problems of Drug Dependence was formed in 1927 to develop non-addictive opioids and non-addictive alternatives for treating pain. We are still searching for that product. For now, prescribers should put the care of their patients first while trying to not fuel harmful use by others. This can include providing the most appropriate medications to treat their pain, along with information and guidance to minimize the risks and harmful use, diversion and overdose, and referring those in need to appropriate treatment for their substance use disorder. Such practice skills can also limit the potential for misuse and leftover medication. Extensive guidance and advice is now available from FDA, CDC, and other sources at the resources listed below and increasingly in the form of expert review articles and commentaries.

For more information about opioids, substance abuse and how you may be able to prevent the issue from happening to someone close to you, please use the following guides:

Additional Educational Resources

Disclosure: We acknowledge the assistance of Pure Communications, Inc., which was supported by Nektar Therapeutics for their help in the development of this article.

Jack Henningfield, PhD is a leading expert on addiction and abuse of prescription medications and illicitly manufactured substances of abuse. He is former head of the National Institute on Drug Abuse laboratory that conducted abuse and addiction liability studies and presently consults to pharmaceutical companies on the development of medicines with reduced potential for abuse.

Sidney H. Schnoll, MD, PhD is an internationally recognized expert in addiction and pain management who applies his experience of over 30 years in academic medicine to the issues of risk management.  He has served on numerous committees and boards including the FDA’s Drug Abuse Advisory Committee (DAAC), NIH study sections, National Board of Medical Examiners test development committees, and the board of the College on Problems of Drug Dependence (CPDD).

Pinney Associates consults with pharmaceutical companies including Nektar Therapeutics and other companies mentioned in this article that market a wide variety of prescription and over-the-counter medications including prescription opioids and stimulants. However, no financial support was provided to the authors for the preparation of this article.

Subscribe to our blog via email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

 

There are 22 comments for this article
  1. Scott michaels at 10:52 am

    will some body show us a accurate number of deaths in 2015 solely from pain medication that originated.from a prescription.
    then a saperate.of illegal opioids like heroin and bootleg pills. This is the only way the public can see the big lie. it aint the prescription deaths , its the illegal drugs like heroin thats killing people. That would only proove the dea is as useless as an unbaited hook. DISMANTLE THE DEA ALREADY AND USE THAT MONEY.FOR DRUG EDUCATION AND ADTER SCHOOL PHYS ED, ART AND MUSIC CLASSES. sell drugs on the street go to prison for 3 years PERIOD. KiDS TOO.

  2. HJ at 4:17 pm

    I would love to see abuse-deterrent alternatives that work and are affordable. When a new drug comes out on the market, the price is beyond my reach. It cannot help me if I cannot afford to purchase it.

    I’m hopeful that measures will be put in place to keep drug companies from bleeding patients dry.

    I’m an asthma patient who previously had no difficulties affording my medications until the very same medications were re-released in a form that “protects the ozone layer.” The drug companies lobbied to have this new delivery method become standard, not because they cared about the ozone layer… but because they could charge patients the brand-name costs for basically a repackaged generic drug. And when does the patent expire for drugs like ProAir? We don’t know. Because patent law is so insane that it’s unpredictable.

    I’ll welcome the day I can order my prescriptions from Canada. I hope the US drug manufacturers will realize that patients are not just “consumers.” We need these medications for our quality of life. It should not be a luxury to have the medications we need.

    I chose my Allergist because his office has samples of my medications to give me. I grovel at my appointments. A doctor visit copay is far less expensive than going to the pharmacy to purchase the medications that literally allow me to breathe.

    I appreciate your message, I sincerely do. I appreciate the hopefulness, but I also want to express my frustration over the brokenness of American healthcare. And yes, thank God there are still people out there who realize I’m not the same as someone who illegally obtained medications and abused medications.

    Thank you for that.

  3. Stephen S. Rodrigues, MD at 10:42 am

    The Whole Truths about you alls pain problems are truly under your noses and at your fingertips.

    If one reviews basic human biology, anatomy, physiology and pathology of diseases you will find the data. The correct treatments for the aches, pains, and stiffness of life and living are physical therapy PT.

    The factual evidence is simple to understand;
    What is a pain?
    Where is the pain located?
    How best to treat the pain in the correct location?
    What is PT?
    What is not true PT?

    It is impossible for your pain to be first located in the brain, nerves, skeleton or nowhere.
    It is impossible to treat the pain you are experiencing with amputating body parts or removing bits and pieces of the joint.
    It is not wise to ignore or denied the existence of your pain.
    It is not wise to only medicate your pain.
    Your pain is not just 0-10.
    Physical therapy is not just a massage.

    The Whole Truth cannot be found in policy, Pubmed or be written down on paper because all the evidence has been tainted, adulterated, corrupted, mixed and messed up. What you all are dealing with are inventions of man and “true and false” which may have nothing to do with The Whole Truth.

    A few AMA members planted the seeds cause of our American health care pain and misery catastrophe in the 60s. They were allowed to fix pain by surgical means. In doing so, they were authorized to break natural laws of human biology. Those in the AMA were allowed to twist the universal Truth of how nature works and put it into a sinister yet nice-looking package. They gave it to the Federal Government to implement which has now infected our entire Society.

    I have a book draft which explains and tells all. The book presents about 200 bits of correct and factual scientific evidence to be able to put the puzzle into a picture. Using human inventions without this knowledge being continuously tested and grounded in reality is like living in the Dark Ages. When a society has no single authority who is in charge of guarding the integrity of science and medicine knowledge, that society will fail its citizens.

    Is this not what we have today the second dawning of a Dark Age?

    In my view it is impossible to solve a problem without pulling up the roots, destroying the seeds, changing out the tainted soil and planting the correct evidence. Godspeed

  4. Richard A. Lawhern, Ph.D. at 6:13 pm

    Holly, many ill-trained doctors are in denial of the reality that literally HUNDREDS of chronic pain patients have shared with me and with you and others: chronic pain patients indeed are much less likely to experience a high when taking opioids, even if they are somewhat sedated. I’ve never seen a full chain of cause-and-effect biochemistry explained which accounts for this effect. But I am virtually certain that it occurs reliably in a huge patient population.

    Regards

  5. Lisa Hess at 6:06 pm

    Dear Dr Rodriques, I had to read your comments 3 times to make sure I was reading it correctly. Your statements “The correct primary location and source of pain everyone will experience within the body are from muscles.” “The correct treatments for muscle derived pain are all under the category of hands-on physical therapy PT,.” and your last statement “Medications cannot touch or benefit muscle derived pain, aches, stiffnesses, and dysfunctions. The use of medications are excluded for support and comfort, NOT as a single option.”

    Dr Rodriques, Do you really believe what you wrote? Do you really believe that muscle spasms occur on their own? As I have been told by several of my doctors, When the nerves become inflamed, the attached muscles are put into spasms. Which in my case, has to be true.

    Do you live in Chronic Pain? Do you not believe in the image evidence we see when we look at our MRIs that can show disc, bone, cord and vertebra damage. Do you have so much nerve damage that there are days when it is so painful to walk? Do you believe that the vertebra and degenerating discs in our spines are all muscle damage and is so bad that you can’t sleep at night for weeks, even months at a time? PT doesn’t fit all sizes and types. I’ve been in PT at different intervals and different therapists for months at a time over the past 20 years (since I was 35 years) in hopes it would help the muscles in my neck and all the way down my spine, but guess what, PT no longer works for my body. There were times PT did work for me for a while after one of my cervical fusion surgeries. Then my Lumbar discs herniated and sat on the Sciatic nerve we tried everything in PT, but after a period of time, my spine goes back to one gigantic spasm and I’m back into PT. I’ve had so many Facet Blocks, epidurals, nerve blocks, spinal cord stimulators, acupuncture, trigger point injections and for the first ten years the only medication I was on was one muscle relaxer at night and ibuprofen. You see, I was an engineer and needed my brain so I could do my job. Back then I didn’t have any idea what opioid pain meds were but thought if I took any, it would get in the way and I wouldn’t be able to perform my duties at work. I went to work every day for the first 10 years living with the chronic cervical pain. I thought I’d rather work to get my mind off the pain than lay on the couch thinking about how much pain I was in. It was in 2006 aftrl I had my third cervical spine fusion that I could no longer stand my pain (and my pain threshold is pretty high). There have been many days I couldn’t do anything even with the medications because my body would suffer. I had been to over 20 different PT organizations since 1996. I had no choice but to start taking the opioids just so I could take care of myself, 2 children and a house as best as possible. I could no longer work. On a rare and lucky day my pain level might get down to a 4 or 5 because the meds were doing their job, I always did too much. Then I would pay a high price and suffer the consequences for days after because I did too much that one day. Now, I have to take up to 3 muscle relaxers a day as well as Opioid Medications just so I can sit up and maybe go out somewhere other than a doctor’s appointment. So, no my chronic pain does NOT start with my muscles but does include my muscles. What started in my neck is now my entire body and my spine is degenerating at an alarming rate (vertebra, dead discs, spurs, Bone Marrow Edemas, small plate fractures, stenosis and so much more.) The sciatic nerve is so damaged it kills me to walk. Injectable procedures are out of question as they could stir up another disease I have. I am no longer a candidate for another stimulator (which by the way works with the nerves, not muscles). Muscle diseases such as Fibromyalgia are controlled with medications like Lyrica and Cymbalta. So my question to you is…Do you live with the pain when every single muscle in your neck and back is spasming and won’t loosen up, the knots won’t go down and your physical therapist tells you and your insurance that there is no more that they could do after 10 consecutive therapy sessions and there’s been no improvement and most likely will never improve. Yes, PT is a wonderful thing, but for a lot of us, it cannot work alone or like me, no longer works on any part of my spine and muscles. So, in this theory of yours, one size does not fit all. I mean no disrespect, just the facts as they are for me.

  6. Holly Clowers, MD at 2:33 pm

    I’m curious that these educated authors seem unfamiliar with the concept that opioids have a different effect in the brain with pain than they do the brain without pain. Generally, someone in severe enough pain to require an opioid does not experience a high from taking an opioid; it is the person in no pain that experiences a high from opioids. Therefore, the risk of addiction is already lessened if you are taking opioids for pain–a high or rush is already unlikely.

  7. Lisa Hess at 7:21 am

    Hello Catherine. Before you moved to CA, what part of the US did you live? On the West Coast they never think to test for Lyme Disease or any type of form or Co-infection of Lyme. Though most doctors think one can only contract Lyme in the Northeastern states, it is a misnomer and anyone can contract it in other areas of the US or other type of parasitic disease. It is also called the “hidden” disease because it hides itself within the Lymphatic system and anything can occur at any time within ones own body without explanation. And, if you had been tested for Lyme before and it came out negative, test again. 60-70% are false negative results. Lyme and related diseases are almost never thought of to be tested, especially on the West Coast. I’m living in Chronic Pain for 20 years originally resulting from a car accident where I suffered severe cervical damage. I’ve had 3 fusions and was told back in 2006 that the damage would NEVER go below C7. Well, it has all the way down to S1. I have Degenerative Disc Disease down my entire spine. Well, 2 years ago I complained my thumb joints hurt so my doctor wrote the script for another RA test (my 5th time in 20 years) and just “threw in” for good measure a Lyme Disease test. I was floored when I found out I had Lyme Disease, and was sent to an idiot impersonating an infectious disease doctor who said I had just contracted the disease 4 months prior and was no longer an active infection and didn’t need antibiotics. Last summer I found out I have a very dangerous Bone Marrow Edema covering both the C1 and C2 vertebrae and one on the L5 vertebra. It was my Pain Mgmt doctor who suggested I go to an AutoImmune dr. who, after asking me about 150 questions of weird symptoms tested me for Bebasia and Bartonella, both co-infections of Lyme. She also said that from the Titers showing on my year old Lyme test that I’d had Lyme for several years, not months! Both of her tests came out Positive and she believed these so-infections were the reason for a lot of the other physical issues I was showing and the BMEs and put me on a regimen of strong antibiotics and Probiotics which all they did was make me sick and I had a jaw infection for 5 months that wouldn’t heal. After 2 months I had to stop the treatment. Fast forward to this year. I couldn’t go back to the AI doc because she stopped taking Medicare, I was so sick all this past winter (besides the excruciating pain from my nape of the neck to my feet–I also suffer from Fibro Myalgia since 2006), and I feel like a ticking time bomb with the BMEs, but I had to find another Auto Immune doctor asap. Couldn’t find a single one within 3 states of my home in NJ. I was recommended to a new Infectious Disease doctor who specializes in Lyme Disease. He’s old, old fashioned, doesn’t believe in the co-infections, be he is really thorough and also believed I had Lyme for several (and I mean a lot) of years. He re-ordered the Lyme IgG and IgM with PCR and come to find out the original Lyme was still active and I had been bit again and my titers were through the roof at 230 (normal is anything lower than 99). He said that some people do not react/cure with oral antibiotics and I just finished my IV treatment 2 weeks ago. Do I feel better, no. Will I feel better, probably not. And, he told me that I probably wouldn’t feel better physically because I already have so much spine damage that is irreversible and because I’ve had the Lyme for what I can count at least 9 years without treatment so the damage is done which in my case most likely the cause of the destruction and acceleration of my degeneration of my vertebra and in the discs from C1-S1. What he is hoping is that the IV treatment would stop the Bone Marrow Edema from Erosion because if it didn’t, I’m in the operating room, sooner than later and I’ll never be able to move my head again. I would suggest you research and find the best Infectious Disease Doctor in CA and go. It could make all the difference and finally give you some answers. I wish you the best of luck.

  8. Bernadette Stevens at 8:22 pm

    Thanks for the reply Lisa. It helps so much to know someone is actually listening. I to am on Medicare. My husband & I retired to Florida end of last year. But do to the medication costs he had to go back to work, He is 67 and deserves the rest. I have been disabled since 2005. But like you, had some really bad medical advice and treatment. Since the CDC & FDA won’t listen to us we need our own little community. Maybe we can get them to read our comments Positive thoughts.

  9. Richard A. Lawhern, Ph.D. at 7:51 am

    We already have drugs that help millions of chronic pain patients to keep at least a marginal quality of life. They’re called opioids. The supposed good intentions of FDA concerning abuse-resistant medications which are less addicting appear to me to be largely a sham.

    The real agenda is to allow drug companies to re-purpose existing anti-psychotic drugs as pain killers, jacking up prices under new patents and ripping off patients for meds that are marginally effective even when they are not demonstrated to be addictive and positively dangerous.

  10. Lisa Hess at 6:55 am

    Well said Bernadette! I know the costs you are talking about. I’m on Medicare because I cannot work and name brand opioids are at a tier of impossible costs so I had no choice but to go to generics which don’t come close to the efficacy of the name brand that I was taking for 9 years. Quality of life, it is now history! Besides a destroyed spine from C1 to SI, I just finished a month of IV treatment for Lyme Disease of which I’ve had for at least 9 years and found out I had it 2 years ago, but the IFD said “I was at the end of the infection, no need to treat.” Idiot. Was so sick this past winter it took me months to find a competent IFD. Took a new Lyme test, found out I was re-infected by another bite and because I was not treated properly 2 years ago, more damage to my spine occurred at a rapid pace that may cause me to have 2 more unwanted surgeries. Thank you DEA for now making my home my prison. Bernadette, I wish you the best.
    Sincerely, Lisa H.

  11. Christine Taylor at 10:38 pm

    Joan Hamm– I do agree to a certain extent with your statement but I would like to add a bit to it. When many people experience moderate muscle type pain and joint pain or headache the right combination of aspirin can help along with strength range of motion exercise. A combination of ASA-caffeine and 8 mg of codeine works extremely well and is available in Canada without a prescription. The dose of codeine is low enough that it just enhances the pain relief. The Brand name is 222’s. I recently gave these to my daughter who has a broken foot and she was concerned as it completely relieved the pain. She ended up over using the injured body part and caused it to get worse. She has an acute injury but if the pain became chronic the medication would eventually have little to no effect on her.

    When 222’s is used early for arthritis or surgery and a person is diligent with doing their physio exercises and change in diet (if needed) developing chronic pain as a result can be stopped. There is a large problem with people failing to comply with the physio portion of recovery. When this happens they can take all the aspirin they want but if the muscles are not being strengthened they will fail to support the joint and cause chronic inflammation in both bone and muscle tissue.

    People fail to comply with the physio portion of their recovery for many reasons. One being that they do not have coverage for physio and cannot afford it. I would like to see demonstrations of exercises on line that target the necessary body part so that affordability might not be an issue. 2– The reason behind the need to do prescribed exercises is not thoroughly explained. Many people who have not had formal education in medical study do not understand the reason why the exercise is important.Patients are more likely to comply if doc/nurse/physio take the time to explain.3–Sick patients are too fatigued to exercise. I am thinking that buddy exercise times can be set up and done via skype. Physio exercises can often be done at home so one need not leave the house. A buddy system will help patients as they would have a commitment to sign on and do not need to worry about traveling. Buddy systems have been known to help people who are trying to lose weight or quit smoking.

    I think doctors are right to say that aspirin and exercise can help but for many with chronic pain these things are just part of their treatment. To assume that every chronic pain patient is not exercising or not trying an anti-inflammatory is ridiculous.

  12. Bernadette Stevens at 10:06 pm

    ‘substance use disorder’ is a pleasant way of saying addict. They should not have preference over those suffering from a chronic disorder, Pain. Many of us will live our lives in constant pain. We will jump through hoops and spend money we no longer have for the few meds we are able to get. They finally found a med that allows me some freedom from pain. Cost of 4 thousand 4 hundred dollars a year. $4400.00. Plus another med at $21,000.00 a year. Can’t work, can’t drive. Missed my Niece’s Wedding, the birth of my Great Niece, her 1st and 2nd birthday. Forced to miss my Nephew’s wedding. These are big as I have no children. The addict has a choice, i do not. Continue to find a safe med for them but do not adjust or cut our meds first. Different ways and meds are for individuals to decide with their doctor without your interference. Thank You

  13. Jeremy Goodwin, MS, MD at 6:25 pm

    Sorry, but this is s lot of clap-trap smoke in the room to try and cover up the politically made up snd followed ‘opioid epidemic’. Those with addiction do not have access to modern concept levels of care. Those with opioid-requiring pain are told to retry all the failed alternatives. Those with both are screwed.

    It is time that the falsehoods and politically motivated pendulum swing away from the care of pain be admitted, apologized for and re-examined.

    It is time that science and not opinion masquerading as such be the judge. Too many are being hurt because of an age old problem that now involves big business pharmaceuticals. Those in pain need care and validation and they do not need to be treated like criminals. It is insane. And that applies to those with addiction too. They need up to date care and compassion. .

  14. Catherine at 4:15 pm

    I wish to leave a sort of testimony just to show how things are really going for patients who actually need it.
    In 2010 I had become sick with bronchitis and ended up in the ER. They said it was “possible” pneumonia and gave me a perscription for Cipro antibiotics. I had stomach pain and felt horrible but didn’t put 2 and 2 together. I was going through a very stressful time where I lost my family due to divorce. I lost everything! I came to California because it’s where my family is . My toes and feet started burning. I also had a Knot in the bottom of my foot. Other symptoms kept coming up. It ended up being a reaction to the antibiotics! Now am I responsible for what the pharmaceutical companies do to us? I didn’t know what to think! I started going to the dr but nothing was never diagnosed. I went to many Drs but they didn’t find anything in the tests! I have been so very stressed due to the
    lack of interest into the cause of my pain. I have been seen by a pain physician since first coming to Fresno in 20100. I had always gotten what I needed. Now in 2016 there are so many problems with references to “abuse” that we are all considered “addicts!” I have not been cut back but changed to a different medicine and given only the minimum amount that will “get me by.” I can’t do anything strenuous like being involved with a job or what others want to do like go to the park, bike ride or cleaning the house, due to not having enough pain medicine to address the extra pain I experience, let alone the increase in pain due to progression of my problems. I am not even sure what is causing my pain because the Government won’t give me SSI, and medi-Cal won’t cover the tests to tell me what’s wrong! There’s too many of us falling through the cracks!! It would be very appreciated if you could stop using poison to “fix the problems!” Go herbal with something that’s proven to work please! There are things out there that work, but we are always going to have to deal with the people who don’t do the right thing but you shouldn’t punish us all for the stupidity of those who choose to abuse!

  15. HAZZY at 2:50 pm

    I take opioids, responsibly. The doctor shoppers are making it bad on us. Ive been taking pain meds for over 18yrs so leave me alone.

  16. Bob Schubring at 1:59 pm

    It is irresponsible to call the epidemic of patient suicides, an “opioid-related death epidemic”. The patient who perceives that his or her pain has worsened, and that this worsening does not concern nor trouble their physician, becomes frightened and anxious. In any other disease condition, a worsening of symptoms prompts a review of the diagnosis. No cardiologist would continue to treat a chest pain as purely cardiac-related, if the pain moved to a new locus in the stomach. Standard medical practice would be to consider the stomach pain as potentially an entirely-new disease, perhaps a stomach ulcer, gall bladder disease, or a cancer. Standard medical practice would call in an expert on one of those conditions, to collaborate with the cardiologist, to treat the pre-existing heart disease and the newly-presented abdominal ailment.

    Patients trapped beneath a chronic pain label, frequently do not get this common-sense medical response. When chronic pain patients complain that their pain has changed, instead of seeking a diagnosis for the cause of the change in their pain, the patient is accused of “drug-seeking behavior”. Worse yet, the patient’s treatment is diminished, once the record of “drug-seeking behavior” has made it into the chart.

    The anxiety this creates in the mind of the patient, makes the perception of pain more intense.

    The patient who cannot find relief, begins to consider death as a release from pain. Thus begins the suicidal ideation, that ends in the patient’s death by intentional overdose, or by self-inflicted gunshot wound.

    Colorado mortality statistics show a surprising revelation.

    The drug cannabidiol is readily available over-the-counter to Coloradans, with or without tetrahydrocannabinol, as an herbal product obtained from cannabis plants. Cannabidiol (CBD) is known to have anxiolytic and anti-spasmodic activity. A Colorado patient with pain, who also experiences anxiety and notices that the pain seems much worse, during anxiety episodes, may freely purchase and consume CBD to relieve the anxiety. The patient whose experience of breakthrough pain, is due to anxiety or spasms, and who relieves the breakthrough pain by treating the anxiety or spasms with CBD, will control these pain flares without altering their opioid dosage, perhaps without reporting the event to their doctors.

    Since cannabis has been re-legalized in Colorado, “opioid-related deaths”, the statistic under which pain patient suicides are mis-classified, are less frequent. Moreover, smaller doses of opioids are being prescribed for pain patients.

    Understanding that pathological anxiety is a separate and distinct condition, from musculoskeletal or inflammatory pain, is the key to realizing why both conditions must be treated, when both are present. CBD is a useful drug for anxiety and spasticity. It can be taken intranasally or sublingually for rapid effect. It does not affect the control of breathing, and therefore does not have the dangerous interaction that alcohol exhibits, when taken with opioids. Opioids are useful drugs for pain. They act on the periaqueductal grey matter of the brain, which is the locus of nociception, and assist the brain in deciding to ignore pain signals that emanate from a pre-existing, non-worsening injury. No other class of drug has this action. The surgeon can use a variety of substances to create a medically-induced coma that makes the patient completely unresponsive to the pain of a surgical procedure, but only the opioids allow the patient to selectively ignore pains that are unimportant or redundant.

    Giving the patient a long-acting opioid for pain and an inhaler for taking CBD as needed for anxiety or spasms, empowers the patient to control both sets of symptoms, rest, recover, and get on with life.

    It is irresponsible for the US government to maintain the fiction, that cannabis plants have no legitimate medical use. They’re necessary to treat anxiety and spasms. They’re the only drug that works, for some classes of epileptic seizure.

    It is likewise irresponsible, for cannabis backers to assert that cannabis is a replacement for opioids. It is not.

    The honest and responsible position to take, is that both drugs have medicinal uses. The patient who benefits from a dosage of both, must have legal access to both.

  17. linda at 11:50 am

    There is a huge difference between addiction and reliance. If you’ve never had chronic pain every day 24/7 you can’t even imagine the hell it is,affecting every aspect of your life and functioning.Now that it’s a big business it seems the pharmaceutical companies are in control,with the incentive being money rather that alleviating extreme suffering, TRy ibuprofen? That is laughable. Like putting a bandaid on gangrene. Try living in this body for 24 hours and then get back to me.there is so much concern for addicts who take Opoids to get high yet little concern for people who DONT get high but are normalized with Opoids. So frustrating.

  18. Stephen S. Rodrigues, MD at 11:22 am

    A few member of the AMA, in the 60s perpetrated a crime, by allowing surgical procedures to treat pain which are not scientifically based, betray, harm, maim and kill millions of Americans.

    These Doctors were allowed to break natural laws of human biology which automatically breaks Constitutional Laws which robes and denies millions of Americans their freedoms of life, liberty, and the pursuit of happiness. These Doctors were allowed to treat:
    Knee pain with joint replacement.
    Headaches with brain surgery.
    Lower back pain by fusing vertebrae.

    Although Man can arrogantly perform these procedures on the human body without the person dying, these surgical procedures are on the wrong tissues.

    The correct primary location and source of pain everyone will experience within the body are from muscles.

    The correct treatments for muscle derived pain are all under the category of hands-on physical therapy PT.

    The correct PT options are the only true beneficial and curative treatments for the exact pathology of muscle pain which are tiny microscopic scars scattered within muscles bundles.

    The pain derived from muscles are triggered by microscars which activate intramuscular pressure sensors.

    Manual labor in lots of effort are the only way to ignite the natural forces from within the true healer of these pain diseases.

    Traditionally PT was accepted and offered upon request of the patients as needed. Over the last 40 years these curative options have been taken away, adulterated, weaken, marginalized, tainted, biased, hidden, or simply denied.

    The AMA and it’s power and influence has even corrupted Federal mandates literally guaranteeing Americans will not have adequate access to cures. These egregious actions are the exact reasons why pain, misery, medical mistakes, polypharmacy, postoperative mortality, and suicides are the leading causes of deaths.

    Medications cannot touch or benefit muscle derived pain, aches, stiffnesses, and dysfunctions. The use of medications are excluded for support and comfort, NOT as a single option.

  19. Lisa Hess at 10:49 am

    Hi Kathy, I know exactly how you feel about having to have our meds to the exact 28-30 day regimen! I also know the feeling of fear that you may not be able to attend a very, very important event. For months I feared I wouldn’t be well enough to travel to see my daughter graduate college this past may which was 9 hours away or if I have my scheduled vacation that is planned years in advance. Some pharmacies will work with your doctor and insurance about getting your prescription filled early due to reasons as stated above. I’ve had to do this for years. I’m on Medicare and allows only once a year to get an early prescription and use Walgreens pharmacy and putting those two together = nightmare, however, if your pharmacist knows you well, insurance companies usually allow a prescription in advance as long as your doctor states on the prescription, must be filled by Date____ due to vacation or will be out of town. I’m always asked by the pharmacy staff “where are you going?” which really infuriates me, because it’s none of their business, especially because they won’t call one of their branches to inform them that you (the customer) will be bringing in a prescription from out of town. I’ve had that problem before too and pharmacies will not fill prescriptions for reasons of out of town doctor than the town you live in, out of state, and my pharmacy claims that they do not have any type of link to the computer systems that has my complete medical history so I’ve had to repeat myself all the time as to why I have to be on the meds I am on. What I do when I know there’s going to be a conflict of dates, I tell my pharmacist as soon as I know when I would have an event I cannot miss, when the prescription will be coming in and who is prescribing it. And, I will only deal with this one pharmacist because I always have a problem with all the rest who work there. I wish you luck and congratulations on your Son’s wedding. You will make it, because you shouldn’t have to miss this special occasion.

  20. Kathy-Jackie Kathleen Walker-Melcher at 7:41 am

    These guidelines have been used to increase the cost of Chronic Pain Patients needed medication. The idea that we should use OTC meds such as Motrin is laughable. You don’t think we have tried everything before we were given some relief by opiates. Now I am tied to a prescription, written to the exact day I will be totally out. I’ve missed vacations and may miss my sons wedding due to my due date. And my pain is under treated due to fear by my DR. I can see why the deaths are increasing. We are committing suicide due to uncontrolled pain and loss of quality of life.

  21. Lisa Hess at 6:34 am

    Well. at least someone has realized that most of the abuse problem isn’t from us, the chronic pain sufferers, but it is those who are given or stolen our medications. And, at least someone has also finally realized how important it is that we have the right dosage of medications so we can try and lead as normal a life as we possibly can. However, how long is it going to take for them to “lift” the current restrictions that are placed on our Pain Management Doctors to prescribe to us the accurate dosage we need to try and have some type of normalcy in our lives. Right now, because of these restrictions, I’ve had no quality of life since my medications had to be cut as of January 1, 2016 and yes, the pain is so excruciating that I pray to be released from this type of life. I hope these organizations make up their minds quickly before more blood is on their hands. We need help now, not later.

  22. Joan Hamm at 4:45 am

    What a joke to expect over the counter drugs will help the severe pain from Cancer or RSD / CRPS!!!!! Ketamine shots work only if given early in RSD. You cannot take away or reduce Medicines to the unfortunate people who suffer horribly without pain meds. If so you will be causing 911 calls daily… More suicides due to the severe pain of these diseases. The idiot Doctor Who claims exercise and aspirin etc..is a quack. Let him get a pain disease he will change his mind. You are making these type of Doctors rich. They are using the government!!! Ketamine shots work if caught early. Many Veterans have RSD. If one sees many Doctors and painful tests to verify RSD it takes time. You cannot hurt these unfortunate people by taking away the medicines that finally stabilized them. I heard of a woman who has a pain disease and she is forced to go to the streets for help. She dont eat much etc. Because she cant get help. I never I In my life took a street drug.. Not even weed cigarette. But I hear horrible stories of people who suffer horribly without a pain medicine. You are paying Quack Doctors who fooled you to believe that exercise and aspirin will help people with pain diseases. Find a scientist who will create a Ketamine type drug to help RSD. Let the Quack Doctor get a pain disease. See what he does for pain. He is using you and going to kill innocent people if you take pain medicine away that HELPS people.