Tag Archives: mark pew

Big Opioid Pharma = Big Tobacco?

Have you noticed that big opioid pharma (BOP), manufacturers and distributors of prescription opioids are under attack? I have.

In fact, I’ve written about it for awhile. You can read “Suing Big Opioid Pharma – The Next Big Thing?” from 3/13/17, “780,069,272 Pain Pills” from 12/20/16, “Suing Big Opioid Pharma” from 9/27/16 and “Patients Sue Physicians’ and Pharmacists” from 5/22/15.

As I’ve followed the strategic initiative, it reminds me of big tobacco. As a refresher, it was accused (informally, at first, and then collectively, over time) of knowing that tobacco was dangerous and addictive but kept it a secret. In November 1998, attorney generals from 46 states entered into the Tobacco Master Settlement Agreement (MSA) with the four major tobacco companies:

The states settled their Medicaid lawsuits against the tobacco industry for recovery of their tobacco-related health-care costs, and also exempted the companies from private tort liability regarding harm caused by tobacco use. In exchange, the companies agreed to curtail or cease certain tobacco marketing practices, as well as to pay, in perpetuity, various annual payments to the states to compensate them for some of the medical costs of caring for persons with smoking-related illnesses. In the MSA, the original participating manufacturers (OPM) agreed to pay a minimum of $206 billion over the first 25 years of the agreement.

See also: Misconception That Leads to Opioids  

Throughout 2017, I have saved every article I read on the subject of the opiod problem (see below). You are more than welcome to read the entire article, but I think the date (constant throughout the year), source (wide variety of publications) and headline (provocative and descriptive) provide a sweeping perspective on the scope of this activity:

The full scope of the opiod crises includes an investigation by Congress; lawsuits by individual states, counties and cities around the country (and in Canada); collaboration among attorney generals; and class action lawsuits. (And maybe others). The initiation of most of this action is not academic, it is personal.

Take Mike Moore, the former Mississippi attorney general who was the first to sue Big Tobacco using a then-unproven legal strategy. His nephew started with Percocet as prescribed by a doctor in 2006. By 2010, he was using street fentanyl. Moore saved his nephew from an overdose by taking him directly to the hospital.

As he’s watched the tobacco victory pay off in declining smoking rates, he’s also seen easy access to powerful pain medication spark a new deadly crisis. He’s convinced this is the moment to work the same mechanisms on the drug companies that forced the tobacco industry to heel — and he’s committed himself to making that happen. “It’s clear they’re not going to be part of the solution unless we drag them to the table.”

The primary argument against BOP is the same as the one against Big Tobacco. BOP knew the dangers of their product, but they misled consumers (in this case, prescribers) by purposefully obfuscating the truth.

See also: Opioids: Invading the Workplace  

If you look at the evidence (anecdotal and factual), it appears as though there was a strategic effort to hide the truth. Of course, all of this in large part is still alleged — not proven in a court of law — and BOP will have an opportunity to make their arguments.

Except… In May, Purdue Pharma settled a class-action lawsuit in Canada for $20 million. But of course, settlements always include the language “no admission of guilt.” As I stated in a post:

$20 million (or 0.064% of OxyContin revenue) to settle? This is a rounding error for Purdue Pharma. But not to those who became dependent/addicted and lost anything from an active lifestyle to life itself. Fair and equitable? That was a rhetorical question — I don’t believe it is either fair or equitable. Not so much the dollar amount, but the fact that it will not hurt Purdue at all in the pocketbook. If the goal of a lawsuit is to change behavior because it’s too painful not to, then this probably didn’t hit the mark.

Whether you believe the opioid epidemic is real or not (I do), or whether you think at least some of the deaths from illicit street heroin and fentanyl are a consequence of over-prescribing prescription opioids (I do), I think we can all agree it’s wrong for a company to tell its customers there is no danger when there really is (and when the company knows it). In this case, it can be deadly.

So if BOP wants to know where this is heading, they just need to refresh their memories about what happened with Big Tobacco. What happened then is about to happen again.

The WC Mistakes That States Make

As 2017 gets rolling, state legislatures are convening all over the country. Several of them are about to make mistakes in the area of medication management in workers’ compensation.

My colleague, Mark Pew, and I have written and spoken extensively on the topic of drug formularies. And we’re currently working, formally and informally, with regulators and other stakeholders in jurisdictions across the country on approaches that make sense for employers, doctors, pharmacists and, most importantly, injured workers. While there’s not a lot to be gained for any of us in calling out individual states, there’s a great deal at stake for all of us in the successes and failures of drug formulary implementations. A failure (perceived or real) in one jurisdiction can lead another jurisdiction to delay its own attempt at a formulary — or to scrap it altogether.

So how can we tell if a law or rule set is headed in the right direction? Or, alternatively, if a state’s efforts are more likely to lead to sub-optimal results? Here’s a quick litmus test that you can apply to make your own determination:

1. Will the formulary rely on independent, third-party medical treatment guidelines?

There’s a great deal of industry discussion surrounding this topic, mostly focused on the definition of “evidence-based medicine.” While that conversation is interesting, it’s not the critical factor in overall formulary success. The crucial questions are twofold: First, will there be room for political influence in the formation of the guidelines? Second, will the guidelines be updated with sufficient frequency?

See also: How Should Workers’ Compensation Evolve?  

2. Does the formulary process build off of existing dispute resolution processes?

States that have successfully implemented drug formularies thus far have done so by relying on existing rules regarding resolution of medical treatment disputes. States that try to simultaneously create a formulary and new dispute resolution processes to support it are, in reality, trying to do two things at once. Not impossible, but certainly creates execution risk.

3. Does the formulary allow for a remediation period for legacy claims? 

On the one hand, a single effective date creates chaos as employers and physicians try to figure out how to address legacy claims, which tend to be more complicated. On the other hand, applying new rules to new injuries creates two standards of care within a workers’ compensation system, where an injured worker’s treatment plan is driven entirely by the date on which he was injured (which makes no clinical sense). I look for regulatory language that takes a balanced approach — an initial implementation date for new injuries, followed by a remediation period for legacy claims, followed by a fully effective date for new rules and all claims.

4. Is the formulary process scalable?  

I always look to see if the dispute resolution process can stand up to a significant volume of cases. While the goal of any formulary adoption should be to streamline access to medically necessary medications for injured workers, states should take a “hope for the best, plan for the worst” approach. Dispute resolution processes that rely on one individual or one office for ultimate resolution may lead to bottlenecks and, in a worst-case scenario, undue influence. I always ask myself, what will this look like if there are more disputes than the state expects?

See also: Five Workers’ Compensation Myths

One bad apple can spoil the bunch. Let’s get this right.

The article was originally published here.

Marijuana and Workers’ Comp

I read an interesting story recently on the front page of Yahoo.com titled “ESPN’s NFL player poll about marijuana had some surprising results.” I then read the source article on ESPN.com, “Survey: Two-thirds of NFL players say legal pot equals fewer painkillers.” The title is fairly self-explanatory.

First, just to ensure we’re on the same page: This is a workers’ compensation issue. The NFL is an employer. The players are employees. The gridiron is a workplace. Pain and injury are realities for the vast majority if not all players/employees at some point in their careers.

See also: 4 Goals for the NFL’s Medical Officer  

The survey was of 226 players, 11% of the total number of players on active rosters and practice squads. So I would consider it a statistically significant sample, and, depending on how the 226 were selected, likely reflective of the full population.

Following are the highlights as tweeted out by @ESPNNFL:

  • Nearly three-quarters of NFL players surveyed (71%) say marijuana should be legal in all states.
  • About one-in-five (22%) say they’ve known a teammate to use marijuana before a game.
  • Two-thirds (67%) say the NFL’s testing system for recreational drugs is not hard to beat.
  • When asked which was better for recovery and pain control — marijuana or painkillers — 41% say marijuana, compared with 32% for painkillers.
  • More than half (61%) say that, if marijuana were an allowed substance, fewer players would take painkillers.

Do these results scare you? Probably depends on the personal opinion you held before you read them. Do these results surprise you? They shouldn’t. According to the Associated Press-NORC Center for Public Affairs Research survey of 1,042 adults in February 2016:

  • 61% said marijuana should be legal, and of those …
  • 33% with no restrictions
  • 43% with restrictions on purchase amounts
  • 24% only with medical prescription

Add to those figures the five states (Arizona’s Proposition 205, California’s Proposition 64, Maine’s Question 1, Massachusetts’ Question 4, Nevada’s Question 2) that voted last Tuesday whether to legalize recreational marijuana. (Legalization was approved in California, Massachusetts, Nevada and Maine — though by such a close vote in Maine that a recount is being requested. The pro-legalization side appears to have lost in Arizona, but the vote is still being counted.) Add to that four other states (Arkansas, Florida, Montana, North Dakota) that will vote on medical marijuana legalization. (Legalization was approved in all four states.) All of that means the landscape looks very different than it did a week ago.

So if you are a private or public employer, an insurance company, a work comp stakeholder, a clinician, a politician or state regulator … How different do you think your specific constituency is from the numbers listed above? My educated guess is that both surveys are fairly representative of the U.S. (the only other country that I’ve been following is Canada, which appears to be along the same trajectory in public opinion). Which means the numbers above are likely to guide coming public policy.

See also: How Literature and the NFL Shed Light on Innovation

So what does this all mean for the workplace? Of paramount importance is to have a jurisdiction-specific (because all states are different) drug policy (pre-employment, post-accident, return-to-work) that explicitly addresses marijuana (because presence does note equal impairment, a characteristic unique to marijuana among intoxicants).

And … keep your seatbelts handy.

Dangerous Confusion on ‘Painandsuffering’

What is pain? According to Merriam-Webster, it is “the physical feeling caused by disease, injury or something that hurts the body.” Which is different than suffering: “to become worse because of being badly affected by something.” Often, these words are treated as synonyms (or as a single word, “painandsuffering”) when they are actually quite different. Pain is what happens to you. Suffering is how you handle it.

The confusion of these two terms can create issues.

The American Pain Society in 1996 described “pain as the fifth vital sign” (giving it equal status with blood pressure, heart rate, respiratory rate and temperature). The phrase created a perfect storm because it coincided with the message being delivered to medical schools and the healthcare industry that doctors had an opioid phobia and were under-treating pain. That was followed in 2000 by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) establishing standards for pain assessment and management. Then the Veterans Health Administration incorporated the new emphasis into its national pain management strategy. So, regardless of where a patient was treated and by whom, the (subjective, patient-driven) assessment of pain was one of the first questions asked and often drove treatment plans.

Then the new approach began to be questioned. A 2006 study by the VA found quantifying pain “did not increase the quality of pain management.” In June 2016, the American Medical Association recommended removing “pain as the fifth vital sign” and connected the idea to the beginning of over-prescribing of opioids. Opponents of the change say it will “make it even more difficult for pain sufferers to have their pain properly diagnosed and treated.” Proponents of the change say “pain is not a vital sign, but more of a symptom, and cannot be measured.”

So far, pain is still the fifth vital sign.

See also: Health Startups Go After 3 Pain Points  

The biggest problem is unrealistic expectations – patients often are told or come to believe they will be pain-free. When they’re not, and their condition becomes chronic, it sows doubt in the mind of both the patient and clinician.

The second biggest problem is that often the circumstances beyond their physical pain is ignored. I am convinced that dealing with what happens between the ears and at home is as important as what is physically wrong with the body (i.e. the biopsychosocial model).

So how is “pain as the fifth vital sign” measured? Sometimes it’s a scale of frowny face to smiley face. But often it’s a comparative pain scale, from 0 to 10. The Health Organization for Pudendal Education (HOPE) offers the best description:

  • 0 – No pain – Feeling perfectly normal.
  • 1 – Very mild – Barely noticeable pain, like a mosquito bite or a poison ivy itch. Most of the time, you never think about the pain.
  • 2 – Discomforting – Minor pain, like lightly pinching the fold of skin between the thumb and first finger with the other hand, using the fingernails. Note that people react differently to this self-test.
  • 3 – Tolerable – Very noticeable pain, like an accidental cut, a blow to the nose causing a bloody nose or a doctor giving you an injection. The pain is not so strong that you cannot get used to it. Eventually, most of the time you don’t notice the pain. You have adapted to it.
  • 4 – Distressing – Strong, deep pain, like an average toothache, the initial pain from a bee sting, or minor trauma to part of the body, such as stubbing your toe really hard. So strong you notice the pain all the time and cannot completely adapt. This pain level can be simulated by pinching the fold of skin between the thumb and first finger with the other hand, using the fingernails and squeezing hard. Note how the simulated pain is initially piercing but becomes dull after that.
  • 5 – Very distressing – Strong, deep, piercing pain, such as a sprained ankle when you stand on it wrong, or mild back pain. Not only do you notice the pain all the time, you are now so preoccupied with managing it that your normal lifestyle is curtailed. Temporary personality disorders are frequent.
  • 6 – Intense – Piercing pain so strong it seems to partially dominate your senses, causing you to think somewhat unclearly. At this point, you begin to have trouble holding a job or maintaining normal social relationships. Comparable to a bad non-migraine headache combined with several bee stings, or a bad back pain.
  • 7 – Very intense – Same as 6 except the pain completely dominates your senses, causing you to think unclearly about half the time. At this point, you are effectively disabled and frequently cannot live alone. Comparable to an average migraine headache.
  • 8 – Utterly horrible – Pain so intense you can no longer think clearly at all, and have often undergone severe personality change if the pain has been present for a long time. Suicide is frequently contemplated and sometimes tried. Comparable to childbirth or a really bad migraine headache.
  • 9 – Excruciating, unbearable – Pain so intense you cannot tolerate it and demand pain killers or surgery, no matter what the side effects or risk. If this doesn’t work, suicide is frequent because there is no more joy in life whatsoever. Comparable to throat cancer.
  • 10 – Unimaginable, unspeakable – Pain so intense you will go unconscious shortly. Most people have never experienced this level of pain. Those who have suffered a severe accident, such as a crushed hand, and lost consciousness as a result of the pain and not blood loss have experienced level 10.

How many times have people said their pain is a 9 or 10 (or a 47) when they’re conscious, sitting upright and drove themselves to the doctor’s office? I have seen that manifold times in hundreds of chronic pain workers’ comp claims since 2003. But it’s easy to succumb to that kind of self-assessment …

I had the flu in February and went to a CVS Minute Clinic. One of the initial questions the nurse practitioner asked me (having been prompted to do so by her practice management software) was my level of pain. I truly felt miserable — body aches, high temperature, sneezing. For a brief moment, because I wanted to ensure a prescription of Tamiflu, I wanted to catastrophize (“an irrational thought a lot of us have in believing that something is far worse than it actually is“) and say I was a 9 or 10. But then I remembered all the times I had argued against that approach. And I remembered exactly what a 9 or 10 meant. So I resisted the urge and gave myself a 5 rating. I still got the Tamiflu that started the journey to recovery.

See also: Better Outcomes for Chronic Pain  

Pain is complicated and individual, so there is not a single answer for quantifying and treating it appropriately. However, I have three high-level suggestions:

  • Re-calibrate the scale. The clinician should educate patients on the true meaning of 0 through 10 and help them decide on a lower number that better describes their pain. That would require an actual dialogue between the clinician and patient. I understand that pain is unique and personal. But if patients can convince themselves their pain is a 6 instead of a 10 (or a 47), then managing it seems much more achievable.
  • Be honest. If there is going to be residual, chronic pain, the patient should know it. And own it.
  • Manage the pain. In my opinion, “pain management” is a term that is often misused. You can’t manage your pain if you’re comatose (i.e. sedated on opioids, benzos, muscle relaxants, et al.). Yet we often see “pain management” as a series of pills or injections that are passive and repetitive (in some cases, I think pain management clinics have become “addicted” to the repeat office visits). At some point, patients need to manage their pain rather than allowing the pain to manage them, and be taught how to do that. That could mean yoga, an active lifestyle, better nutrition, biofeedback, proper sleep hygiene, deep breathing exercises, mindfulness, volunteer work or any number of other methods in combination or isolation that work for the patient. The key is an internal locus of control (“he or she can influence events and their outcomes“).

I’m not saying pain isn’t real. For those dealing with chronic pain, it is very real. But I’ve chatted with and observed too many people with significant chronic pain who overcome it on a daily basis to live productive and happy lives. I know that chronic pain does not have to win. Instead, we need to re-define pain, re-define suffering and help people take back control of their lives.

I will finish with this wisdom from Dr. Stephen Grinstead:

  • Thoughts cause feelings
  • Thoughts + feelings = urges
  • Urges + decisions (choices) = actions
  • Actions cause reactions
  • Reactions could help or hurt management of pain

In other words, how you think about pain influences how much power pain has over you. So think differently.

A Heroin Vaccine — Is It Possible?

Yes, you read that right. A vaccine for heroin.

I first ran across this concept on Twitter last week. I saw a posting from @heroin_research about a heroin vaccine. I was trained by my parents, and through practical experience over the past 55+ years, I’ve learned that if something sounds too good to be true then it probably is. This sounded too good to be true. But, being The @RxProfessor, I had to check it out. And that led to a Saturday conversation with Caron Block.

Caron’s son has been in recovery from heroin for over four years. It has been a long journey. Unlike the new trend in heroin users, his abuse did not start with a legitimately prescribed opioid after an injury or surgery. It started with drinking himself to sleep in 8th grade, then escalation to marijuana, then meth, then cocaine, then heroin. Naloxone literally saved his life multiple times from an overdose death. He has had open-heart surgery for Endocarditis (a heart valve infection very common with heroin users). He was adjudged to be a “use till death” person given the nature of his genetic predisposition to addiction. By all accounts, the fact that he is still alive is a miracle. That he’s on his way this Fall to Columbia University after restarting his education at a community college is astounding. While his battle with addition will last a lifetime, his is a story of victory … achieved every single moment of every single day.

See also: Progress on Opioids — but Now Heroin?  

But Caron knew that her son’s victory was unfortunately not common. She had personal experience with death and devastation among friends and family. Many of his friends (past co-users) have died. And many still use. Rather than preaching to those still suffering from the addiction, he’s trying to lead by example. But it is frustrating. And overwhelming. And so that turned Caron into an evangelist for the work of Kim Janda, Ph.D., the Ely R. Callaway Jr. Professor of Chemistry at The Scripps Research Institute (TSRI), and his pursuit of immunopharmacotherapy. He is really smart, working initially on a cocaine vaccine, then a nicotine vaccine, then a methamphetamine vaccine, and now a heroin vaccine. Note that each drug requires it’s own unique vaccine, so a heroin vaccine will not be an opioid vaccine. But it’s certainly a step in that direction since the heroin vaccine deals with morphine, one of the two metabolites, along with  6-acetylmorphine or 6-AM, that come from heroin, which as a chemical actually only lasts for about 30 seconds in the body.

If you have 47 minutes available, watch this YouTube video titled “Heroin Vaccine and Understanding Addiction with Dr. Kim Janda & Caron Block.” If you only have 5 minutes, a June 28, 2016 article published by Science News entitled “Vaccines could counter addictive opioids” is a detailed accounting of the vaccine. Included is a sobering statistic:

More than 60 percent of people with addiction experience relapse within the first year after they are discharged from treatment

In essence, the heroin vaccine “trains the immune system to usher the drugs out of the body before they can reach the brain.” Just like how all vaccines work, it creates antibodies and turns the immune system into the front-line defense. In this case, it keeps heroin away from the brain. The “active vaccination” is primarily to help people get through rehab/detox or to stay clean afterwards (even if they relapse, the vaccine has made heroin an enemy of the body and they can’t get the reward effects of the drug). Importantly, the vaccine is only valuable to those who desire to defeat their addiction, so vaccine recipients would need to be carefully vetted. The expectation is three to four boosts would be needed every two weeks to build up the antibodies that could last for several months. For more details, please read the Science News article.

According to a January 2015 TIME magazine article

In 2013, preclinical trials of the drug on heroin-addicted rats showed those vaccinated didn’t relapse into addiction and were not hooked by high amounts of heroin in their system. “It’s really dramatic,” says Dr. George Koob, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) who was involved in the heroin vaccine research. “You can inject a rat with 10 times the dose of heroin that a normal rat [could handle] and they just look at you like nothing happened. It’s extraordinary.

In 2015 TSRI and Dr. Janda received a $1.6M grant from the National Institute on Drug Abuse (NIDA), with the potential of three additional years of funding, to support pre-clinical trials of the heroin vaccine. That is really good news. TSRI has a very specific plan forward:

  • Pre-clinical meeting with the FDA
  • Production of the vaccine under cGMP
  • Animal toxicity studies (2 species)
  • Efficacy study in another animal model (likely primate)
  • IND filing with the FDA prior to initiating human trials

The corresponding bad news is that a lot more money will be required to take it to human trials and ultimately to FDA approval and production. They have estimated a minimum of $10.5M and 3 years to get through Phase II trials, after which they’ll need even more money and time for Phase III trials, NDA application, FDA review and approval. There are a lot of financial headwinds for a variety of reasons (if you consider a heroin vaccine reducing demand, you can probably speculate on who might not be supportive). Caron is doing her part with a Facebook page and the aforementioned@heroin_research on Twitter.

Dr. Janda believes that addiction is perceived to be a moral failing (of the individual or society as a whole) where it should be seen as a brain disease. Dr. Nora Volkow, Director of NIDA, believes in “treating addiction like a disease that needs to be managed, such as diabetes or high blood pressure, with a multiplicity of treatment options would help addicts find a treatment that works well for them over the long haul.” That stigma certainly doesn’t help fundraising.

See also: Opioids Are the Opiates of the Masses  

I’m an ALL OF THE ABOVE kind of person. For any complex multi-dimensional issue, there is no single solution. We need Medication Assisted Treatment. And greater access to substance abuse and mental illness treatment facilitated by the series of bills recently signed into law (“What will $180 Million Buy Us?“). And the use of PDMPs to identify prescription drug abuse/misuse. And the trending yet controversial “safe spaces” for heroin users to be guaranteed clean needles and clinical oversight (and, hopefully at some point, a recognition for the need to change). And any number of other initiatives around the country focused to combat the dual epidemics of painkiller and heroin abuse.

At this point, I’m a believer that this is not “too good to be true.” But it might not ever be one of the solutions available without other evangelists and dollars to fund the research to validate whether this really works on people.

Are you willing to be an evangelist? Do you know somebody who would be willing to be an evangelist? Do you have access to research dollars? If the answer to any of those questions is “yes”, let me know. Or contact Caron (@heroin_research). Or contact Christopher Lee (clee@scripps.edu) at TSRI. It would be yet another tragedy for this vaccine to hit a dead-end because of funding. If it truly does work, this should be one of the biggest no-brainers in our lifetime.