Take aim at the battleship, not the dinghy

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Last week’s Consumer Reports cover story, “Special report: The dangers of painkillers” highlights the important issue of prescription pain drug abuse in our country. However, they missed the mark on several important points that will now just add to the existing confusion and misinformation in any real attempts to solve the prescription drug epidemic.

The article underscored the health risks surrounding overexposure of acetaminophen, but failed to acknowledge that, unlike other hydrocodone products, Zohydro ER is the only hydrocodone product that does not contain additional active medications, the most common of which is in fact acetaminophen. This important differentiating factor makes Zohydro ER an important, safer treatment option for patients with severe chronic pain who can no longer tolerate or have a medical contraindication to acetaminophen (or combined ibuprofen) yet are doing well on hydrocodone, some of whom have no other opioids options due to poor response or intolerability.

Their article also overestimates the role of abuse deterrent technology (ADT) in preventing prescription drug abuse. While it is part of the solution, it is not the ONLY solution nor is it the best.[1,2]  More importantly, if it were the panacea, insurance and other third party payers are not willing to pay for opioids with ADT, leaving only the more affordable generic (non-ADT) opioids as an option – so a world with only ADT products would inherently discriminate against the poorest underserved opioid-requiring patient populations, likely the very same population that is at higher risk of opioid abuse.   We must use a comprehensive approach that does include ADT, but also sensible legislative policies, prescriber and patient education, tools and resources like locking prescription bottle caps. The key is to stop opioids from getting into the wrong hands, not deny access to those who have a legitimate need for them.

Sadly, Consumer Reports continues a pattern followed by many in the media of whipping up fear over the dangers of opioids without also providing balance by considering the benefits that these important drugs have for patients who use them appropriately.  This has unfortunately had an adverse effect on legitimate pain patients and has served to fuel fire love anger in those unfortunate families who remain to grieve over a loved one that has succumbed to opioid addiction, eventual overdose and death.  The media has been grossly irresponsible (as addressed in multiple of my blog posts categorized here) by ignoring the whole truth, and [educated] politicians should be ashamed for using the misfortune and grieving of others to bolster a bully pulpit by which to gain popularity while hanging their legitimate pain patient constituents out to dry.

As always, comments are welcome and encouraged!

References:

  1. Twillman R, Fudin J. Potential Cost-Shifting And Hidden Costs And Risks In The Economic Analysis Of Opioid Abuse Deterrent Formulations. Pain Medicine. 2014. doi: 10.1111/pme.12489
  2. Kirson N, Shei A, White A, et al. Societal economic benefits associated with an extended-release opioid with abuse-deterrent technology in the U.S. Pain Med. doi: 10.1111/pme.12489.

22 thoughts on “Take aim at the battleship, not the dinghy

  1. Hi, my name is bert espinoza,
    I’ve been taking,hydrocodone,for 30 yrs.for back related injury. I’ve been up the latter, from, ancient, davocets,up to morphine..sadly, this didn’t work for me. Due to stomach or side effects of sorts. I’ve seen,pain specialists,done pain alignment, all sort of theorys. Except, surgery,which I won’t do, to talking to 2 very important surgeons from samsun clinic,in Santa barbara,CA. Dr.Jones and Dr.Connery. I have,asked very doctor,I’ve seen, for blood tests to be done at least on a yearly time for checking my liver, kidneys etc.I cannot take any nsaids due to history, of ulcers from family,genes etc. Now I am taking only Norco 10. I decided yrs ago, not to climb the ladder of opioid. I’ve been told, that they won’t work, due to your body, getting immune to them. Well, this may be true.but they take the edge, off my pain,to the point of me having a quality of life to function. The so called, opioid,crisis, will soon be a crisis of withdrawals,depressions, quality of life and etc..in a higher,way.. many deaths are caused, by people mixing, their drugs with illegal,to much drink, and other factors. Why I ask,,why, do they punish the need for them, by people that are more level headed, to those who misuse them, wrongly….help.

  2. Hi Dr. Fudin, I too was astounded at the article in consumer reports that stated their conclusion that Opioids are never a good solution after reviewing 30 different pain studies. I have been a contributor to Consumer Reports but never again after being painted a drug abuser. They jumped on the manic hysteric bandwagon epidemic of misinformation being fed to the media by PROP pain doctors and perhaps the political establishment that wants to claim victory in the war on drugs by targeting we the innocent. I cannot get Zohydro ER in my state of WA because as a doctor told me, “I can’t believe this dangerous drug was ever allowed on the market”. Presently, I must take compounded Hydrocodone (to remove the Abuse Deterrent Acetaminophen which I am allergic) and it only lasts for four hours. Zohydro ER would allow me to sleep uninterrupted through the night instead of waking up four hours after bedtime in severe pain to take another dose. I rarely get complete full restful sleep and never dream anymore. This madness is unbelievable to realize that I do not have a right to be treated rationally and correctly with the best medication to assist me in living my best life as a father to my children. I wish you all strength and health as you make this world a better place for we the hurting who are feeling marginalized. Thanks… I have an outstanding compassionate doctor now but it took me one year to get medication so I suffered needlessly in the cold rain due to discrimination caused by HB 2876 passed in 2010. Poor sleep and lack of sleep is hurting me terribly as I see myself aging too quickly. I am open to any suggestions about states and doctors you can recommend. I cannot drink alcohol ( I get sleepy and no Euphoria from my heritage that includes a Polish Jew) and no medication has ever made me high/Euphoric including Hydrocodone. I have severe side effects to most all medications due to drug resistant genes and I tried medical marijuana (pushed here in Washington state) which gave me severe stabbing cramping pain from two puffs which started in my legs. Hydrocodone is a life saver for me and it makes my life better by taking the edge off my severe chronic pain from eight herniated discs in my spine caused by a drug abuser on Heroin who rear ended me!

  3. As a chronic pain suffer as a result of a spinal injury and multilevelcervical fusion, I would very simply kill myself if my pain were not treated. Period. No distinctions are drawn anymore between dependence and pathological addiction. I am so tired of twenty-something pharmacy aids looking at me like an addict every time I fill my monthly precription, the smug smirk on the face of the nurse at mydoc’s office as she hands me my prescription each month, a smirk that says, “wow, what a druggie you are.” Medicine has left the tracks; the current witch hunt on narcotics is no different than any other political demonization. Patients with a true need are lumped together with abusers, diverters, thieves, and seekers. God help us, and cancel my subscription to Consumer Reports.

  4. Your predictions of a rise in heroin use have already come true in my small town. Why oh why won’t they listen to the experts. I see more problems arising than this new law has even thought about fixing coming true & it’s gonna get worse. We are losing family members due to this sham of a legal decision.

    1. I predicted years ago to many about the Herion use going up, few years later my state had a serious problem on its hands all over the media. Any pain patient or Dr should have seen that coming. Government does not care they want to appear to look good with solutions then blame something or someone else when it backfires or act like it didn’t. People can talk about someone who abuses and OD’s and yes that is tragic but is thier life more important than mine or any others? Lets ban cars, planes, lawn mowers, bicycles, swimming pools etc etc cause people die at about anything… people die from drinking and drunk drivers so ban alcohol and cars make them hard to get and limit them.

  5. Thank you for this excellent blog post. I also appreciated the many well-informed replies. I don’t know what it’s going to take to bring about ethical and compassionate care for chronic pain sufferers. What is happening now is anything but! I get so tired of being treated like a drug addictio when I have NEVER abused my pain meds in the 7 years I have had to take them. I live in constant fear that my doctor will stop prescribing narcotic pain meds because he is just as fed up of being put under a microscope as I am. I endure the humiliation of having to give a urine sample every time I see him because of the stranglehold he is under by legislators taking the easy way out. Let’s face it, it’s far easier to attack legitimate and responsible pain patients than to actually get to the heart of the problem. I’m certainly not saying I have the answers, but bullying pain patients and the doctors who try to help them certainly isn’t one of them!

  6. Jeff: Excellent blog, thank you! I would add to your list of ways to reduce drug misuse better use of the PDMPs by prescribers/dispensers. Some have suggested integrating PDMP data with the EHR so that when a physician reviews a patient’s medical history and record, he or she can be aware of a very important component of that history, namely, the past medication record of controlled substances. Now that PDMPs have been around for awhile some jurisdictions are expanding their use to prevent, for example, Medicare and Medicaid fraud by doctor shoppers. PBMs and others who process third-party benefits claims are also finding PDMP information useful in identifying and stopping prescription fraud. Lastly, as for ADT, the “first generation” was in the 1980s with Talwin NX, using the agonist-antagonist principle. The “second generation” uses more advanced polymers (e.g., PolyOx) that inhibit parenteral use of oral formulations and may even retard bioavailability of crushed tablets taken orally for a bolus effect. Two issues to consider: 1) what are the legal implications for prescribers who fail to prescribe ADT formulations, when available, to their high-risk pts with hx of SUD? and 2) How long will it be before FDA requires all ER oral opioids to use polymers like PolyOx in their formulations, both branded and generic? Best regards and thanks again for this very enlightening blog.

    1. John, It is indeed encouraging to read comments like this from you, especially considering your background with the DEA and law enforcement. Your insight is incredible and in many ways beyond mine. Thank you for sharing and clarifying some of the issues.

    2. John.. the PDMP is not the panacea that many believes that they are. Pharmacist have no way of validating the ID of the pt .. Using a driver’s license… they are forced to accept at face value what is given to them and send that information to the PDMP on every Rx filled after the first one. Just do a web search on “how to make a fake driver’s license” and see how many thousands of responses you get. IMO.. the only people that the PDMP is going to catch are those that are too stupid,lazy, cheap to get fake ID’s. The ones whose business plan is diverting drugs… have all the multiple licenses and they are the ones we need to look for. One of the state I am licensed in the Board of Pharmacy requested the BMV to allow them to cross reference the Driver’s license number in the state PDMP against their database and the BMV REFUSED and the AG backed them up. on a issue of privacy.
      NPLEx is even worse… you pull up their website and enter in a driver license number and if that license has been accepted at another store.. the system self populates the remainder of the screen data points. and confirmation bias kicks in for the pharmacy staff. Indiana has been using this system for several years and we are NUMBER ONE in math lab busts and the number keeps growing year after year.. We are using 20th century mindset against 21st century crooks.

  7. Great article, many excellent points made.

    I am against requiring ADT. It is a HUGE cost burden and addicts always find a way. ADT doesn’t stop someone from simply swallowing too much pain medication. Idiots and addicts will always be with us, but it is certainly long past time to stop saddling legitimate patients with their misdeeds.

  8. My wife has Crohn’s.

    In my continuing quest to educate people about what it is like to suffer with a chronic illness, I have a new blog titled “Don’t Punish Pain” as well as a new video series called “Feel This Pain.”

    Whereas my first video, “The Slow Death of Compassion for the Chronically Ill,” was a half-hour presentation on the changing attitudes in society towards those who suffer from chronic illness, the “Feel This Pain” series will attempt to convey what it is like to experience different types of chronic pain.

    “Feel This Pain” Video Link:
    http://tinyurl.com/ouduzjc

    “The Slow Death of Compassion for the Chronically Ill” Video Link:
    http://youtu.be/6UyPlF66KME

    Don’t Punish Pain Web Site
    http://www.dontpunishpain.com

    I also have a Facebook Community Page:
    https://www.facebook.com/dontpunishpain?ref=hl

    Thanks for letting me share here with you.

    Ken McKim

  9. Cost is a big factor for the disabled. My monthly income is $900 monthly. I have 9 prescriptions I am suppose to take. Because of my insurance I can get a 90 supply for what 30 days would cost. Because of regulations I can only get a 30 day supply of narcotics even though in 10 years I have never been short but I pay triple.My co-pay. Is 10’s more for name brand vs generic. I have 3 ( not narcotics but counts lyrica) name brand. Why change what works? I went through a horrific period on kandian with constant sweating and zero pain relief. Just saying change may not always be better. Thank you for this forum.

  10. I believe Abuse Deterrent Technology should not be required for any Extended Release Opioid formulations . Reason is it restricts how the time release mechanism suppose to work and its pain relieving qualities for around the clock relief of chronic pain .ADT turns the medication in to sludge that pain sufferers can not digest. Things are bad enough for those in chronic pain and this makes things worse. And why would anyone want a Instant Release Opioid to be Abuse Deterrent ,this type medication is for Flare Ups or Break Through pain and suppose to work fast and efficient. Abuse Deterrent Technology was invented not to help chronic pain sufferers but to satisfy all that think these medications are not necessary in helping those in chronic pain.

    We can do one of two things either treat chronic pain as it should be treated or try to satisfy all that never suffered a day in their life with ADT, making the life of a chronic pain sufferer more difficult.
    The way things are going your lucky to get a opioid script filled to begin with , why change what works well to begin with, its not broken. All chronic pain sufferers I know don’t abuse.
    As time passes more negative stories like this one are published ,more and more chronic pain sufferers are left untreated or unable to get a legit script filled .So what good does ADT do when a in hand legit /medically necessary /on time script cant be filled because pharmacies are restricted on what they can order each week.

    This is becoming more like torture for all that truly suffer from chronic intractable pain. But we here in the U.S. do not torture people ,or do we, look around at all these suffering people ,what comes around goes around. And here we are right back where we started in worse shape than before for all that truly suffer in chronic pain. Please publish this comment on Consumer Reports and lets get the true story out there for all to read.

  11. Jeff, you mention a critical issue that seems to be rarely discussed: What are insurance and other 3rd party payers (including Medicare and Medicaid) willing to pay? New, brand-name opioids with ADT come at a premium price that usually is not covered by insurance and many payers deny claims for such drugs outright. How many patients in need can afford to pay $200, $300, or more out-of-pocket per month for pain relief? How many practitioners know (or care about) the costs to patients of the medications they prescribe?

    1. Stew,
      Good points! I’m betting that we’re talking more in the neighborhood of almost twice the costs you outline. Does anyone really think that patients or anybody else wants to foot the bill for these drugs in legitimate patients specifically because subversive characters are selling non-ADT opioids or others are abusing or unfortunately addicted to them? There certainly is a catch-22 here that has largely gone ignored by the politicians sitting on their high horses. Who will pay for these? Will Senator Joe Manchin ask the Mylan folks in his backyard to stop making generic extended release opioids? – DOUBTFUL!

  12. Over the last two years I have posted columns on The National Pain Report on FB telling the other side of this egregiously lopsided story. But, alas, I’m only read by hundreds and those that do read me are mostly people living with harrowing pain. I recently took to task a friend of mine writing for the National Gun Victims Action Council, of which I’m an active member, for painting addicts and patients with the same scurrilous stroke.

    I have begun to despair of getting anyone in the main stream media to cover both sides of this story, It is quite reminiscent of the ghastly media hype around crack cocaine in the late 80s and early 90s. The underlying racism in that madness was hardly disguised. I fear that something similar is happening with this: all users of opioid medicines are addicts, and since we are all addicts our stories hardly need telling.

    As always, I urge those so moved to tell their stories to their state and federal legislators. But this is a tall order as many suffering from pain have neither the energy or desire to make themselves known. This is confounded with what seems to be a general disdain for anyone legitimately using these medicines as the average person cannot see the pain in another.

    Truly, pain patients are increasingly invisible.

  13. I was very disappointed with the article from Consumer Reports for all of the same reasons you pointed out, Dr. Fudin. I also was amazed at their clueless remarks about Zohydro and Acetaminophen. I wrote a comment on their article telling them these things as well as a suggestion they stick to reviewing bath soaps and cars, while refraining from reviewing something they apparently know nothing about; medication.

    I feel like I have tried very hard to get someone to do a story on pain patients and their plight as a result of overreaching laws and scare-tactic media coverage using overdose numbers from years ago and never coming close to telling both sides of the story. In fact, you can honestly say these stories rarely even mention there IS another side to the story.

    I was contacted as one of nine people who was interviewed by a reporter, Mr.Jeff Finn, for possible media coverage. We had a nice thirty minute conversation during which, Mr. Finn seemed interested in the story, I asked when or if the story would be printed and where. He asked me to forward a couple of original pieces I had written, which I did, and he would forward these along with the interview to his “people” in L.A. I haven’t heard anything else, but I keep shooting comments out there, going so far as to suggest things such as, “Any reporter worth their salt would want to tell the OTHER side of the story,”

    The fact that there are few if any takers for the “other side of the story” is, in my opinion, all about selling stories. It’s just more interesting to read about drugs and overdoses, mayhem and crooked doctors, than it is to read about someone who can no longer do the things they need to because of the pain they are in and the lack of adequate pain medication.

    See Link for the following page:
    “Opposition to Kentucky HB 1-Reform HB 217 aka “Pill Mill Bill”
    https://www.facebook.com/pages/Opposition-to-Kentucky-HB-1-Reform-HB-217-aka-Pill-Mill-Bill/595049517218134

  14. Another poignant blog. Although I believe ADT should be required for all ER and IR opioid formulations there are only two formulations that the FDA has recognized have the technology. None of the generic ER formulations have ADT. As you point out, Consumer Reports singled out only one of the ER formulations without ADT. I do not understand why they were not critical of all ER formulations without ADT. Of course we know there is a cost difference between Zohydro and generic ER formulation without ADT. Worst yet is the cost difference between Zohydro and methadone and methadone is associated with more deaths per prescription than any other opioid. If safety is the main concern (and it should be) let’s demand honesty and transparency with the conversation.

    1. Well said Dr. Webster! I’m starting to learn that sometimes a shorter blog is better. This encourages experienced experts [like you] in the field to share opinions apart from my writings. Many thanks!!!

  15. Excellent point! While there is need for abuse deterrent opioid therapy, the development of these formulations is extremely costly and has the potential to place an even greater burden of risk on a population already at high risk for opioid abuse. It is our responsibility as healthcare practitioners to not set our patients up to fail.

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