Calls for FDA Commissioner to Step Down Over Opioids

Anti-addiction advocates have sent a letter to Secretary of Health and Human Services Sylvia Burwell calling for FDA Commissioner Margaret Hamburg to step down.  The letter itself is worth reading.

I was in the audience at the National Prescription Drug Abuse Summit here in Atlanta back in April when Dr. Hamburg attempted to address some of the decisions the agency has made.  I can understand the tension created by the need to balance public health with the FDA's role of approving medications on which million upon millions of R&D dollars have been expended.  My view: it's not that she doesn't get it, it's that she's erring on the wrong side of the issue.  Public health concerns should be the primary lens through which her agency assesses new pain medications and that's simply not the case right now. 

The letter is signed by many organizations, most notably Physicians for Responsible Opioid Prescribing (PROP).  This organization has worked tirelessly to push back against the tide of prescription drug misuse and abuse and the regulatory system that enables it.  If you haven't seen or taken advantage of their education materials, you absolutely should.  Every person in medical and claims management can learn something about opioid abuse here: PROP web site. 

While I don't think Commissioner Hamburg will step down, the press coverage of the letter shines a spotlight on the issue and calls into question the behavior of the key federal regulatory agency responsible for approving new pain medications.  I think this will help push us toward a more comprehensive and responsible view of opioid prescribing.  

Michael
On Twitter @PRIUM1

Unfunded Mandates and Patient Safety

Last week, several New Jersey state legislators convened a press conference to announce a legislative package intended to stem the tide of opioid and heroin overdoses in the Garden State.  And quite a package it turned out to be: 21 bills are included, covering everything from mandatory insurance coverage for behavioral health to the use of naloxone to prevent overdoses.  There appears to be enough in the package that everyone has something they like... and everyone has something they don't like.  Should make for interesting politics.

One key piece of legislation in the package caught my eye.

The bill requires the mandatory registration and use of the Prescription Monitoring Program (PMP) among New Jersey physicians.  Everyone likes the concept of the PMP, but the Medical Society of New Jersey has an issue with requiring doctors to consult the database prior to writing prescriptions. Should this bill pass, New Jersey would join Oklahoma, Kentucky, New York, Tennessee, and Massachusetts as the only states that require doctors to consult the database prior to writing prescriptions for pain management medications.  If New Jersey legislators are smart, they'll include provisions (like Oklahoma did) creating exemptions for hospice and other end-of-life care situations.  Additionally, they'll prohibit lawsuits against physicians for not checking the database.  While a patient can't sue a doctor for not checking the database, the doctor would still be in violation of the law and subject to sanctions, punishment, etc.

Doctors often refer to such requirements as an "unfunded mandate."  By that, they mean additional requirements are being placed on them with no additional remuneration.  But this is fundamentally about patient safety.  Are the pre-surgical verification steps outlined by JCAHO an "unfunded mandate"?  What about the commonly expected best practice of physicians washing their hands between patients?  These are things we do in the healthcare community to protect patients, physicians, and other stakeholders from the unintended consequences of care delivery.  I can't understand how that logic doesn't extend to opioid prescribing.

New Jersey is headed in the right direction.  I hope they don't screw it up.

Michael
On Twitter @PRIUM1

Medical Marijuana is NOT the Answer to the Opioid Problem

At least not yet.  But the conclusion being drawn by many a reporter in our industry would have you believe otherwise.  "Fewer Opioid Related Deaths in States with Medical Marijuana" read one headline.

A study published in the Journal of the American Medical Association at the end of August is causing a lot of confusion in our space.  The abstract of the study (which is, unfortunately, all that most reporters seem to have read) states the following: "States with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate... compared with states without medical cannabis laws."  One has to crack the cover and actually read the study to understand this conclusion results from a multi-variate linear regression model that compares behavior of individual states that have medical cannabis laws to what the behavior might have been in that state without such laws.  I have absolutely no issue with the the methodology or the related conclusion.  I'm a data geek and I love a good linear regression model as much as the next guy.

But on page 3 of the study, you quickly learn that the actual observed historical data tells the opposite story. States with medical cannabis laws exhibit a consistently higher opioid overdose mortality rate vs. states without such laws.  Marcus Bachhuber, the lead author of the study, points out that its hard to compare states to each other and much more statistically relevant and reliable to compare states to themselves (what does California look like vs. what we would expect California to look like without a medical marijuana law?)  This is a perfectly valid academic exercise, but not one from which we should be drawing policy conclusions.  Dr. Bachhuber himself writes in the study, "In summary, although we found a lower mean annual rate of opioid analgesic mortality in states with medical cannabis laws [again, according to the linear regression model, not the observed historical data], a direct causal link cannot be established."

Kudos to Ben Miller at WorkCompCentral, who actually read the entire study and presented a balanced view of the issue in his article yesterday.  I was interviewed for and quoted in the article and stated the case much like I'm stating it here. I was impressed that Ben was willing to dig beyond abstract and take his story in a direction he may not have originally intended.  We need more reporters like him in our industry.

Bottom line: Medical marijuana laws cannot be said to lead to a reduction in opioid overdose deaths.  

Michael
On Twitter @PRIUM1

What's Actually Happening at the Pharmacy?

A lot, it turns out.  The local retail pharmacy represents another front, and a complicated one at that, in the battle against prescription drug misuse and abuse.  And you need to be aware of what some injured workers are facing when they take their prescriptions to the pharmacy.

Pharmacists are asking doctors questions about medical necessity... and doctors don't like that.  "They [pharmacists] call us sometimes and if (a prescription) is medically necessary," says Dr. Rafael Miguel, an anesthesiologist in Tampa.  "Well, if I write a prescription and it's got my DEA number and my signature on it, what do you think, I'm joking around?"

No, no one thinks this is a joke.  But pharmacists, insurance adjusters, case managers, other physicians, public health workers, and many others think you might be lacking key clinical knowledge regarding the appropriateness of certain prescriptions (yes, even doctors can be under-educated).  We don't think it's funny, we think it's tragic.

Then again, are pharmacists the right ones to be asking this question?  I have neither the clinical knowledge nor the courage to weigh in on that, but it's a question with which the healthcare industry is currently wrestling.  There is new tension in the traditionally high functioning relationship between doctors, pharmacists, and patients and pain killers are at the center of that tension.

For pharmacists and doctors reading this, nothing new here.  But for insurance industry personnel, it's important for you to get up to speed on the details of what's happening in the midst of an ordinary pharmacy visit.  We're revisiting some fundamental questions about the roles and responsibilities of various clinical constituencies.  I'm confident the pendulum (currently swinging at different rates in different directions in different places) will eventually come to rest where it should.

In the meantime, be on the look out for injured workers caught in the crossfire.

Michael
On Twitter @PRIUM1

The Rescheduling of Hydrocodone: Don't Get Too Excited

The Drug Enforcement Agency has published its final rule on HCPs - hydrocodone containing products - which will be rescheduled (from schedule III to schedule II) beginning on October 6.

The two areas that appear to be of greatest concern in the market regarding this move are:
1) The impact on pharmacies which will now be required to handle, store, and dispense these drugs with greater restrictions going forward, undoubtedly increasing costs for pharmacy operations; and
2) The impact on patient access.  Will patients in pain still be able to get these drugs?

On the first issue, we should all acknowledge the reality of retail pharmacy operations.  This will cause changes and those changes will lead to increased costs.  While I would argue the clinical and public health benefits of the rescheduling of HCPs outweigh those costs, I'm not running a retail pharmacy.  My hope is that these costs trend down over time as pharmacy operators adapt to the new routines required.

To the second issue regarding patient access, let's keep in mind that a rescheduling of a drug may not necessarily impact prescribing patterns.  Yes, schedule II drugs cannot be written for more than a 30 day supply and each prescription requires an office visit.  This will inconvenience some patients in chronic pain.  That said, there are "work arounds".  At the Georgia Workers' Compensation Education Conference here in Atlanta yesterday, I moderated a panel regarding medication usage for the treatment of chronic pain.  A suggestion was made that some doctors may just write two 30 days scripts with a "do not fill before" date on the second script.  Voila! 60 day supply.

Most troubling, though, is the sentiment I've heard from several workers' compensation professionals that goes something like "if a patient really wants the drug - and they will still want HCPs - they'll jump through whatever hoops necessary to get it."  On the one hand, I get it.  It's not as if cynicism in our industry doesn't have obvious and ubiquitous roots.  On the other hand, we cannot allow patient directed care to dictate appropriate treatment pathways for injured workers.  The rescheduling of HCPs should signal to physicians that the drugs are potentially more dangerous than we originally thought.  Doctors, not patients, should therefore be engaged in differential decision making.  If patients are going to be involved in that decision at all (and they certainly should be), the discussion should surround the significant risks and limited long term benefits of opioid use - not figuring out what hoops they have to jump through to continue getting it.    

Bottom line: The rescheduling of HCPs is more symbolic than anything else.  After 15 years of debate and discussion, the DEA, FDA, and clinical community have finally decided that virtually all opioid analgesics should be scheduled the same way (on schedule II, indicating high potential for abuse).

But don't expect to see a huge drop in HCP scripts in work comp.  Our expectations of what's possible are far too low for that to happen.   

Michael
On Twitter @PRIUM1

A Defense of New Opioid Guidelines

[Another guest post from Dr. Pamella Thomas, PRIUM's Medical Director.  Recently, another physician challenged both the science behind ACOEM's 50 mg MED threshold as well as its applicability to chronic pain cases. This was the response from Dr. Thomas.]

Dr. ----

Hope all is well.

I am a bit surprised that you would challenge the 50 mg morphine equivalent dose (MED) threshold supported in the updated ACOEM guidelines.  We are in a CDC-declared opioid epidemic.  People are dying needlessly.  It is difficult to dissent against ACOEM’s 50 MED threshold when the reported death rate is 3 to 5 times greater in patients prescribed 50 mg MEDs and above than in patients prescribed 49 mg MEDs and below.  For context the current CDC VitalSign report shows that, nationally, 46 opioid overdose deaths occur each day.

Furthermore the ACOEM guidelines are – contrary to your suggestion – both applicable to and directed toward chronic cases.  As the most recently updated standards for the practice of occupational medicine, ACOEM further reveals our developing understanding of opioid best-practices.  There is simply no credible evidence to support long term opioid use for chronic non-cancer pain.  Conversely a Cochrane review demonstrated that back pain patients taking opioids for more than a week, when compared with a similar cohort taking opioids for a week or less, were twice as likely not to return to work within a year.  A related review contradicted the practice of escalating doses.  High doses of opioids were shown to be no more effective than lower doses of opioids, supporting the intuitive notion that once opioid receptors are saturated, increasing the dose does not yield additionally beneficial results.  If you have not yet read the two studies used to confirm the new ACOEM morphine equivalent dose (MED) level, you should.

Another concerning issue that pain management physicians among others are not taking into account?  Up to 30% of patients can’t properly metabolize approximately 25% of drugs currently used clinically due to inherent pharmacogenetic deficiencies (Wang et al., 2009).  Drugs in this grouping include codeine, tramadol, oxycodone, hydrocodone and many synthetic and semisynthetic opioids which are not adequately metabolized by other CYP450 isoenzymes.  As result many patients are building up levels of the parent drug causing cascading effects such as hyperalgesia, which in turn often causes the treating physician to further increase dosage.  Dose escalation is often pursued instead of weaning without documenting either improved function or reduced pain.

Following a psychosocial evaluation, most patients feel better once weaning starts in conjunction with pain management and mind-body therapies (e.g. cognitive behavioral therapy, motivational interviewing, etc.).  However, only about 4-7% of patients are ever evaluated for these potential treatment options despite prolonged treatment and a history of attenuated improvement.  Similarly medically indicated evaluations for dependence and addiction or interventions for smoking cessation are often left unaddressed.

My feeling is that a number of clinicians still practice based on an outdated biomedical model instead of utilizing a growing body of evidence supporting a psychosocial model of pain and its correlation to impairment and disability.  It is ignored that psychologically and/or socially distressed people seek medical treatment for psychosocial conditions.  Due to this lack of recognition, many psychosocial conditions are being managed through inappropriate modalities and passed off as anatomically  diagnosed biomedical pain.  These inappropriate modalities (e.g. opioids, surgery, and interventional treatment) share complicit complications and side effects that further exacerbate long term disability and failed syndromes.

Consider that in October 2010, the CDC published a report indicating that over 60% of US children had suffered some form of traumatic abuse prior to the age of 18.  These same children grow up and enter the work force.  Some of them eventually file claims because of unresolved, unaddressed issues amplified by a work related injury, leaving the worker feeling victimized by a supervisor, a poor work environment, or low wages.  Injecting opioid treatment into this psychosocial complexity without addressing the underlying issues leads to long term disability and frequent social isolation due to unsympathetic family, friends, and coworkers.

I hope that this will help clarify why the decision was made that, when people are dying daily, we cannot apologize for taking action to ensure patient safety.  While we realize guidelines take time to be updated (MTUS is being rewritten currently), an epidemic exists at this moment which can be controlled by removing the cause.

We do not want to be downstream catching bodies but upstream saving lives.

Thank you for your understanding.

Dr. Thomas
On Twitter @PRIUM1

PDMPs: At Least Someone in Missouri is Paying Attention

Missouri is the last state in the union without an approved Prescription Drug Monitoring Program.  While that's inexcusable and embarrassing, it also has real consequences for the state.  Past legislative attempts to create a database have met with resistance from Dr. Robert Schaaf, a family practice physician and Missouri state senator.  The St. Louis Post Dispatch published an op-ed on the topic yesterday, which reads, in part:

"Sen. Schaaf, a family practice physician, said his opposition to the database is about freedom. The drug database would infringe on patients’ personal liberty, he says.

Of course, his opposition makes life easier for greedy doctors and unscrupulous pill-pushers, and more dangerous for drug addicts.

Dr. Schaaf is not opposed to all databases or impinging on the freedom of poor people. He voted in favor of legislation in 2011 that required the state Department of Social Services to set up a database to screen some welfare recipients for drug use.He also voted last session for a bill that would have required the state Division of Workers’ Compensation to develop and maintain a database allowing employers access to workers’ compensation records. 

So much for freedom, eh, Dr. Schaaf?"

Ouch.  

I've spoken to Senator Schaff directly on this topic and asked him to explain the inconsistency of his positions.  I'm not sure he understands the importance of the issue at hand.  

You can find a front page article from the NY Times on this here.

The St. Louis Post Dispatch op ed is here. 

My past critique of Sen. Schaaf is here and here. 

Hopefully this national media attention will get things moving in Missouri... and convince Sen. Schaaf to change his position.  

Michael
On Twitter @PRIUM1

H.R. 4709 Offers Little Help in the Fight Against Prescription Drug Abuse

If you want to bill that purports to mitigate prescription drug misuse and abuse, but actually has no hope of doing so - well, look no further than the 113th Congress.  Turns out they can be counted on for something.

Rep. Tom Marino (R-PA) is sponsoring H.R. 4709 which passed the House yesterday and now heads to the Senate.  The bill's purpose is to "improve enforcement efforts related to prescription drug diversion and abuse..."  It does so by amending the Controlled Substances Act (CSA) to more clearly define that certain drugs may represent an "imminent danger" to the public (though it doesn't name those medications, it just makes it possible to designate such medications) and to make it easier for the DEA to leverage the CSA to suspend certain medications that pose a substantial public health risk (though, of course, pharma companies are given the opportunity for remediation with the Attorney General before a drug is actually suspended).  The bill also calls for the Department of Health and Human Services to report back to Congress on law enforcement activities related to patient medication access and, in so doing, consult with every possible constituency and stakeholder on the planet (including tribal law enforcement agencies).

I wonder if anyone in Congress will ever have the courage to do what's actually needed.  Namely:

• Take on the American Medical Association around the issue of mandatory physician education for pain management and opioid prescribing.  The AMA consistently argues such a measure would infringe upon the practice of medicine.  That ship has sailed.  The good doctors want this education and seek it out anyway.  Doctors who either aren't aware of the need for education or are willfully ignorant of best practices in opioid prescribing should be required to engage in such education before prescribing opioids.  
• Provide more federal funding for state level Prescription Drug Monitoring Programs (PDMPs) and additional funding for a fully integrated, national PDMP database.  We're seeing regional efforts along these lines that are promising (see Ohio and Kentucky collaborating on PMIX), but more needs to be done in the areas of standardization, integration, data sharing, access, etc.  The federal dollars currently flowing to these initiatives are minuscule given the severity of the problem.  The Harold Rogers Prescription Drug Monitoring Program and the National All Schedules Prescription Electronic Reporting Act are both under-funded and under-utilized.  California legislators fought tooth and nail over $3 million to fund its CURES database and it's still woefully under-funded and under-utilized. The federal government's FY2015 HHS budget contains $10 million through the Substance Abuse and Mental Health Services to "help state substance abuse authorities develop comprehensive prevention approaches through collaboration with state partners and integration of health information exchange systems with strategic plans."  A) I don't know what that means; B) It's not enough.  
• Leverage data and surveillance from the Medicare and Medicaid programs to identify and deal with high prescribers of opioid medications.  To be fair, the federal government is already working toward this.  See page 73 of the HHS budget overview.    
• Take on the pharma companies through better Congressional oversight of the FDA approval process.  FDA is and should be an independent agency, but serious doubts have been cast regarding the agency's independence and consistency regarding approval of opioid analgesic formulations.  

More needs to be done.  More can be done.  HR 4709 has little chance of moving the needle.  

Michael
On Twitter @PRIUM1

Abuse Deterrent Opioids: Technology vs. Medical Necessity

Last week, the FDA approved Targiniq ER, an extended release / long acting opioid with abuse deterrent properties.  In this case, the Purdue Pharma medication contains naloxone, which blocks the euphoric effects of the oxycodone when the pill is crushed and snorted (or crushed, dissolved, and injected).

I've posted thoughts along these lines before, but I'd like to remind everyone that abuse deterrent opioids are an excellent solution to a limited set of misuse and abuse issues posed by prescription analgesics.

I wish to be perfectly clear on this point: I am 100% supportive of abuse-deterrent formulations of prescription opioids.  These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication.  But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).

To me, though, this conversation is a distraction.  While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem.  The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed.  Very little pill crushing.  Very little intravenous injections.  Very little drug dealing.

The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins. 

Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue.

Michael
On Twitter @PRIUM1

Utilization Review: Tough Love is Best Practice

[A guest post from David Price, PRIUM's Compliance Counsel.  I'll direct any comments you might to have for response.]

“If you would persuade, you must appeal to interest rather than to intellect.”
                                                                                                            -- Benjamin Franklin

Promoting change is hard.  I feel like it’s particularly difficult in the sphere of workers’ compensation.  Between physicians, injured workers, payers, employers, and attorneys, there are multiple competing interests at stake, and policy makers are hesitant to change the existing laws and risk inviting backlash from the groups that don’t feel like they’re benefiting from the change.  The people that shape workers’ compensation law – whether they’re legislators, administrative officers, or judges -- want to promote the public good, but most importantly, they want to make sure that the system is fair.  They want to make sure that no one is getting cheated.  Once they feel like someone is getting cheated by the law, change suddenly becomes much easier.

When a new law is being discussed, there’s always a temptation for us to discuss only the aspects of the changes that benefit us – to only consider our side of the overall story.  What we say might be true, but it’s not always persuasive, particularly if we don’t discuss how the change will benefit other interested groups.  When we only talk about how the change benefits us, it’s no surprise when some of those other groups start to complain that the change is unfair… or when policy makers start to believe them.

Promoting good policy requires honesty, but more importantly, it requires effective honesty. 

I recently had the opportunity to attend the annual Tennessee Workers' Compensation Educational Conference.  This year, the conference was set up so that audience members could text their comments and questions to the speakers throughout each presentation.  This way, audience members could ask their questions while they were still fresh in their minds, and the speakers could finish their presentations without interruption and then come back to address the questions afterward.  As a bonus, because the comments were submitted anonymously, people weren't afraid to ask questions or offer their perspective on each issue.

For better or worse, there was a lot of honesty in the room.

Dr. Robert Snyder, the Medical Director of the DWC, discussed the DWC's plan to adopt treatment guidelines by 2016.  Additionally, several presenters made reference to Tennessee's current UR process, and there was some brief discussion of what the UR process would look like once the treatment guidelines were implemented.  

The comments from the audience, understandably enough, were more concerned with how UR could be used effectively to reduce medical costs.  Unfortunately, many of the comments were essentially expressions of outrage at the irresponsibility and attitude of entitlement of injured workers.  Commenters made a strong case for how UR (and by extension, the guidelines) could be a useful tool to beat drug-seeking claimants.  That may not have been the most effective form of honesty.

With legislators and workers' compensation judges in attendance, commenters touted UR and the guidelines as purely cost-reduction tools and, at one point, a presenter, in response to a question, made the suggestion that in 2016, adjusters, not UR physicians, should apply the new treatment guidelines, and that any request complying with the guidelines should not be subject to UR.  

The overall message was clear: the point of treatment guidelines is to reduce medical costs.  Since they’re really just a tool for the adjuster to use to “beat” the injured worker, maybe we should let the adjustor apply them directly, without getting a medical opinion.

If you ask any claimant's attorney, they'll tell you that all injured workers (or at least their clients) have a legitimate medical need for whatever treatment their doctors recommend, and that payors are just using treatment guidelines and UR as tools to get out of paying for treatment in order to save money.  UR and treatment guidelines are just tools to “beat” the injured workers -- at least, that’s how they tell the story.  Notably, their version frames UR and treatment guidelines as tools aimed solely at saving payors money.  They do this because they know that if they can show UR and treatment guidelines as being implemented solely to benefit the payor by harming the injured worker, it makes the whole process seem unfair.  Any policy maker with the slightest sense of empathy will try to find a way to undermine or limit application of the guidelines.

So here's where I say something that may be controversial:  The primary goal of UR and evidence-based treatment guidelines is to ensure proper treatment for the patient.  Cost reduction is a bonus -- a secondary effect.

Don't get me wrong: from the perspective of insurance carriers and self-insured employers, cost reduction is going to be the primary goal.  Most payers are for-profit entities, and their focus is (and should be) on reducing costs.  That said, policy makers have a different role.  Their focus should be on the public good, and if we continue to allow the debate to be framed as "patients' medical need vs. payers' bottom line," payors will lose every time.  If we talk about treatment guidelines as something that only benefits payers, we can expect to see those guidelines undermined at every opportunity.

We need to be careful in how we tell the story.

There is a very real public policy battle here, and not just in Tennessee.  In Louisiana, several courts have limited the application of the state's treatment guidelines.  In California, the infamous Dubon decision is being used by injured workers' attorneys as a means to attempt to escape the UR/IMR process.  Oklahoma has implemented a closed formulary based on the Official Disability Guidelines, but the state legislature has effectively limited application of the formulary based on date of injury.  (Only claims under the jurisdiction of the new Workers’ Compensation Commission – those claims with a date of injury of 2/1/14 or later – are subject to the closed formulary).  In multiple jurisdictions, we're seeing judges and other policy makers limit the opportunities to apply objective medical standards.  

Why?  The primary reason is a concern for due process.  At the risk of greatly over-simplifying the points raised in each of these instances, the general underlying concern is that the objective medical standards aren't really objective at all (or at least aren't being applied objectively), and so a "fair" determination of medical necessity can only come from a judge.

Now, in Tennessee, the DWC is planning to adopt treatment guidelines by 2016, but which guidelines will be adopted -- or how they will be utilized -- remains to be seen.  We can be certain that the way we talk about treatment guidelines and the UR process now will greatly affect the way the process is shaped as the guidelines are implemented, and whether or not policy makers see application of the guidelines as an "unfair" intrusion onto injured workers' right to due process.

We can be just as certain that when the guidelines are implemented, work comp and appellate judges will see a host of objections.  No doubt, many of those objections will echo the arguments that have been made in other jurisdictions.

If we talk about treatment guidelines as something designed to benefit only the payer -- and especially if we promote them as something that payers should be able to use without requiring a physician’s opinion (I don’t envy the attorney that has to defend a non-medically-trained adjusters determination that a physician’s recommended treatment isn’t medically necessary) -- we’re buying into a very dangerous story.  It’s the same story every injured worker’s attorney will tell in 2016 when the guidelines are applied.

To be honest, treatment guidelines do reduce overall medical costs, but that's not the whole story.  If that's how we allow the discussion to be framed, we can expect to see more limitations on when and how guidelines are applied -- in Tennessee and elsewhere.

The vital part that’s missing from that story is that, in reality, evidence-based treatment guidelines are designed to benefit injured workers, and that’s precisely what they do.

The reality is that injured workers usually don't know what treatment is appropriate; they only know what their doctors tell them.  The reality is that treating physicians are torn between their duty to help the patient recover as quickly as possible and the lingering financial incentive toward excessive treatment.  The very nature of the workers’ compensation system, and sometimes even the patients, can pressure physicians to treat in ways that contradict their best medical judgment.  At the same time, even the most honest and strong-willed treating physicians are hard-pressed to keep abreast of current medical evidence as they try to operate a successful practice, and many are particularly under-educated regarding the proper prescription of opioids for pain.  The reality is that evidence-based treatment guidelines provide an objective standard of care and, when used correctly, can protect the injured worker from improper treatment, overdose, and addiction.

That's the truth, and that's how we should tell the story.

David
On Twitter @PRIUM1

Senate Bill 526 overwhelmingly passed the Missouri Senate on February 13, (26-7).  Not exactly a predictable outcome based on what we know about Missouri.

The bill calls for the development of a database of work comp claims that could be accessed by employers when hiring job candidates.  It will next be considered by the state House, and if passed the database would be implemented on July 1, 2015.

Creating a database of work comp claims could potentially allow employers to assess in a pre-employment screening process whether their prospective employee has submitted work comp claims.  It’s not the same as asking your age or your marital status that could potentially be used to discriminate, but that past history could certainly influence an employer’s willingness to hire you.  I’m all for transparency in the hiring process so you can make a well-informed decision on a very expensive process.  

Here's the odd part: if Missouri is willing to create this database, why are they unwilling to create a PDMP (prescription drug monitoring program) that could yield very important information about an individual’s entire drug regimen that has potential life and death consequences?  The primary obstacle to the PDMP in Missouri has been state senator Rob Shaaf, who has argued that "letting the government have your very personal and sensitive medical information on a government database, it's just wrong and Big Brother shouldn't have that effect on our lives."  He voted in favor of SB 526, perhaps because the bill includes a provision that requires employee consent for an employer to search the database.  Nonetheless, the database will be contain sensitive information on Missouri citizens, will be run by the government, and will have a much wider potential audience (all employers) than a PDMP (clinicians and law enforcement). 

Still waiting

Michael
On Twitter @PRIUM1

I like David DePaolo.  A lot.  He is a voice of reason in our industry and I've enjoyed his musings, both personal and professional, for years.

But on the issue of urine drug monitoring, I think he's off the mark.  On the one hand, I'm coming at this from an admittedly self-interested perspective (PRIUM is a wholly owned subsidiary of Ameritox), but on the other hand, the context and conclusions of David's recent post on drug monitoring beg for someone to clear up the confusion.

What did he miss?  Nowhere in his piece did he mention that:

• People are dying.  Overdose deaths from prescription opioids now outpace deaths from traffic accidents and have tripled since 1990; 
• The CDC has identified the opioid crisis as an epidemic, a term the CDC does not use lightly; 
• More than 12 million people reported using prescription painkillers nonmedically in 2010; 
• Urine drug monitoring technology is relatively new.  David's quote from the CWCI data that suggests 192X growth in spend on urine drug monitoring in CA doesn't recognize the point at which the health care community sat on the adoption curve for this technology in 2004.  Nor does it recognize that we still didn't realize the enormity of the opioid crisis in 2004.  And don't tell me we knew in 2004 how bad this was going to get.  I came into this industry in 2010 and spent my first two years here at PRIUM trying to convince payers there was an opioid problem in the first place.   
• There's a distinction between point-of-care testing in a doctor's office and reference lab testing. Failing to make this distinction leads the reader to conclude that all inappropriate behavior rests with reference labs and fails to recognize that some physician practices are by themselves driving inappropriate utilization.  Physicians who partner with experienced and capable reference labs that understand payers' perspectives and expectations can help align stakeholders (injured worker, physician, lab, and payer).   
• There are guidelines for the appropriate use of urine drug monitoring and these guidelines are based on risk stratification of the patient.  We follow these guidelines.  We help payers follow these guidelines. Testing beyond the guidelines is as inappropriate as not testing patients that should be tested.  
• Even in light of these guidelines, WCRI data tells us that less than 25% of injured workers on long term opioid therapy are being tested at all.   David states "we know [the guidelines] are specific case recommendations particular to a certain set of medical facts, not to be applied universally."  Agreed.  Perhaps David doesn't realize how many injured workers fit that "certain set of medical facts."  A lot more than he apparently realizes.  
• Not all companies offer direct financial incentives to physicians.  He lumps an entire industry together and does so just a couple of paragraphs after he details that Millennium's practices were found by a jury to be illegal and that all counterclaims against Ameritox were dismissed.  Perhaps David missed the most important take-away: there's at least one company trying to do it right. 

Bottom line: what David blithely dismisses as "nonsense" is, in fact, a critical patient safety tool, a mechanism for effective claims management, and a necessary application of clinical technology that isn't going anywhere. To suggest otherwise in light of the largest man-made epidemic in the history of the world is simply irresponsible.  

Michael
On Twitter @PRIUM1

CDC Reports: First Substantial Decline in Overdose Deaths in any State in the Last 10 Years

New reports from the CDC show that progress is possible in the fight against prescription drug misuse and abuse.  Highlights from each of two reports released yesterday:

From Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines:
States can take other actions that will affect prescribers. Developing or adopting existing guidelines for prescribing OPR and other controlled substances can establish local standards of care that might help bring prescribing rates more in line with current best practices. State Medicaid programs can manage pharmacy benefits so as to promote cautious, consistent use of OPR and benzodiazepines. In addition, a number of states have passed laws designed to address the most egregious prescribing excesses. Florida, for example, enacted pain clinic legislation in 2010 and prohibited dispensing by prescribers in 2011. It subsequently experienced a decline in rates of drug diversion (17) and a 52% decline in its oxycodone overdose death rate (18). Guidelines, insurance strategies, and laws are promising interventions that need further evaluation.

And from Decline in Drug Overdose Deaths After State Policy Changes, Florida 2010-2012:
This analysis showed that policy changes in Florida were followed by declines in the prescribing of drugs, especially those favored by Florida prescribing dispensers and pain clinics, as well as by declines in overdose deaths involving those drugs. Florida has reported that approximately 250 pain clinics were closed by 2013, and the number of high-volume oxycodone dispensing prescribers declined from 98 in 2010 to 13 in 2012 and zero in 2013 (2). Law enforcement agencies in Florida also reported that rates of drug diversion (i.e., channeling of prescription drugs to illicit markets) declined during 2010–2012 (6). Preliminary data for the first half of 2013 from the FMEC indicate a continued decline in oxycodone and alprazolam overdose deaths (4). These changes might represent the first documented substantial decline in drug overdose mortality in any state during the past 10 years.


Progress is possible.  Guidelines, insurance strategies, regulatory/legislative action, and common sense education are the keys to mitigating this epidemic.  The CDC reports yesterday put data behind what we already knew to be true.

Michael
On Twitter @PRIUM1

A Better Approach to Chronic Pain Management

[A guest post from PRIUM's Medical Director, Dr. Pamella Thomas]

Maybe the discussion for specialists treating chronic pain should shift away from what law governs their treatment plans and toward what they should really be treating in chronic pain patients. 

The traditional biomedical model of chronic pain assumes chronic pain occurs because of deviations from normal and measurable biological (somatic) variables. In other words, there is always a direct causal relationship between a specific pathophysiological process and the presence and extent of a particular symptom.

Physicians are not, by and large, viewing the individual patient through the biopsychosocial model, which sees pain and disability as a complex interplay of biological, psychological and social factors that, when properly understood, can be assessed and managed. The operative word here is ‘managed’ as any other chronic disease would be managed, instead of trying to treat as you would an infection which is acute and can be cured with the correct medications. Treating chronic disease starts with objective measures of current status and function followed by a treatment plan to manage any distortions. Looking at these treatment records with the paucity of adequate clinical evaluation data and any objective supporting documentation, it is not surprising that continuing opioids is the only constant treatment plan. The patients are all "constant and stable"!

Some physicians unwittingly miss this distinction and do not educate the patient to set the right expectations.  This leads to failures, delayed recovery, and unnecessary disability and cost.  For example, neuropathic pain which traditionally was thought to develop in a primary peripheral nerve is now seen with recent investigation (using functional neuroimaging techniques) to have a large centralized nerve component (in conditions such as chronic low back pain, fibromyalgia, irritable bowel syndrome, and CRPS).

Pain psychopathology and physiology have to address the various components generating this pain. This may include cultural background, belief systems, relationships and interactions with the environment, including home, work, and social environments, as well as their interactions with the disability system and their health care providers.  All of these interactions contribute to the continuing pain when not recognized and managed according to evidence based guidelines.

This leads to neurobiological causes of persistent pain, when structural and functional CNS changes may amplify and maintain the experience and disability of certain pain conditions.  We know stressful stimuli can trigger potent analgesia, mediated by endogenous opioid systems in the CNS. The large prolonged levels of opioids being prescribed in these conditions are more than likely increasing pain from hyperalgesia, leading to intractable pain conditions.  These patients usually do better when weaned and adjuvant and/or co- analgesics are used along with integrated multimodal non-pharma therapy that addresses the pain triggers in the individual patient.  Along with patient education (emphasizing that pain is a perception that needs to be managed without opioids long term), this usually leads to a 'cure' and return to function.

If the treating physicians are following the science, then the point of governing law becomes moot. Instead, we focus on evidence based best practices.

Dr. Pamella Thomas 
On Twitter @PRIUM1

The Demise of American Medicine: Lawsuits and Federal Legislation

I recently read two news items back to back, one regarding a lawsuit and the other a physician-written editorial in Forbes.  My coincidental consumption of these two items left me wondering about the fundamental practice of medicine in the 21st century.  

Much has been made in the last couple of days regarding the lawsuit filed by two California counties against five large drug makers for waging a "campaign of deception" to inappropriately promote use of potent painkillers like Oxycontin.  Tom Lynch provided an insightful overview of the suit, particularly in his emphasis on the lawsuit's intentional and powerful analogy to the tobacco fight of the last century. 

Irrespective of the lawsuit's legal standing and chances of success, I find the nature of the suit itself to be a sad commentary on the nature of the medical profession.  No one directly employed by any of these pharma companies ever wrote a single script for an opioid.  Physicians wrote the scripts.  Some were ill-informed (purposefully, the suit claims).  Some were improperly influenced (despite their better judgment, one can only assume).  And some openly championed the broader use of opioids as Key Opinion Leaders (KOLs), paid handsomely by the pharma companies to do so (leading, no doubt, to the aforementioned ill-informed group of physicians).      

Add to this Dr. Scott Gottlieb's piece in Forbes, "How American Doctors Lost Their Professional Autonomy."  He outlines the practical implications of the Sunshine Act, which requires doctors and pharma companies to disclose virtually every interaction they have with one another, from the ubiquitous giving away of simple pens to the $50,000 consulting fees paid to some doctors.  Gottlieb points out that this act is emblematic of a broader principle: "Underneath the imposition of the Sunshine Act is a far more troubling revelation: Washington has little faith in American physicians, and sees a need and a license to regulate just about every aspect of medical practice, even trinkets doctors receive.  There's a clear view that doctors can't be trusted to have any financial interactions with drug and device makers, no matter how small or simple these transactions."  He further cites the fundamental failure of professional medical societies to engage in any meaningful self-regulation, thus ceding that duty to the federal government.  Gottlieb calls this "the demise of American medicine."   

There are many, many more good doctors than bad.  But the bad doctors are certainly making it harder on the good ones to operate with the professional autonomy most doctors believe is required to deliver sound medical care.  

So where does that leave us?

Michael 

Follow me on Twitter @PRIUM1

Medical Marijuana: The Decision that Never Should Have Happened

Two of the biggest questions around the legalization of marijuana are: 1) whether or not the carrier or self-insured employer is going to have to pay for it; and 2) whether or not that payment violates federal law.

New Mexico just answered the first question for payers in their state.  The Court of Appeals just released its decision in the Vialpando v. Ben’s Automotive Services and Redwood Fire and Casualty case, in which they upheld the WCJ’s decision to require the carrier to reimburse the injured worker for his medical marijuana expense.

Under the New Mexico Workers’ Compensation Act, an employer is required to provide the injured worker “reasonable and necessary healthcare services from a health care provider.” Section 52-1-49(A)  The decision focuses on the definition of health care provider, and whether or not marijuana is a prescription drug or a service.  At no time does the court bring up the fact that the treatment with medical marijuana might not be medically necessary nor in line with evidence based medicine. 

New Mexico recently adopted medical treatment guidelines, and on July 1, 2013, the Official Disability Guidelines went into effect and all medical services rendered pursuant to the most current version of ODG is presumed reasonable and necessary. 

With respect to the use of medical marijuana, the Official Disability Guidelines state that medical marijuana is “not recommended for pain” treatment.  Therefore, it is unlikely that a health care provider in that state could consider it reasonable and necessary treatment.

Perhaps the issue of reimbursement, which could potentially violate federal law, could have been avoided altogether by making an evidence based medical argument first, and the legal/procedural argument next.  After all, we are ultimately talking about appropriate medical treatment, which is a clinical issue that should be discussed and determined by clinicians, not lawyers and judges.

Your thoughts?

Michael

Follow me on Twitter @PRIUM1

Great Data/Studies to Start Your Week

A paper published this week by Accident Fund Holdings and Johns Hopkins University on physician-dispensed medications offers incredible insight into the costs associated with doctors dispensing medications directly from the office to injured workers.  The work is particularly valuable not only because it's so thorough, but because it examines total cost of claims.  There are lots of great statistics here, but the one that jumped out at me: the average claim in the study for which there was never a physician-dispensed medication incurred total claim costs (medical + indemnity + other) of about $33,000.  The average cost incurred on a claim for which there was at least one physician-dispensed opioid?  Almost $57,000.  That's a 70% increase.  (With the analysis controlling for gender, age, acuity, etc.)  Wow.

CWCI has published a research update on use of Schedule II and III medications in the CA work comp system.  The analysis is great, the results are not.  The use of both S-II and S-III opioids ticked up through the first half of 2013 from levels observed in 2012 (19.3% of all prescriptions were S-III, up from 19.0% in 2012... and 7.3% of all scripts were S-II, up from 7.2% in 2012).  Perhaps most notable is that CWCI estimates that nearly half of S-II opioids used in workers' compensation are for minor injuries, where medical evidence doesn't support the use of opioids (nor do the FDA labels on long-acting/extended-released opioids).  If we're spending approximately $1.5 billion on opioids in work comp and we estimate that $750 million of that is inappropriate... What does that mean for injured workers?  What does that mean for state workers' compensation systems?  What does that mean for the PBM industry?  What does that mean for your business?   The implications are significant.  

Finally, there was a piece last week that aired on NPR that should be required listening/reading for everyone in workers' compensation.  We've known for some time that low back injuries are frequent, surgeries (and subsequent surgeries) often don't appear to help, and that long term opioid use is a typical result.  We also have studies that suggest what injured workers with low back pain need to do: move!  Don't fear the pain. Get up and exercise.  This piece puts a human voice behind that logic.  Imagine if all injured workers with low back pain (even those who have suffered failed back surgeries) went through this program.  

Have a great week.

Michael
On Twitter @PRIUM1

What if it's the Opioids Causing the Pain?

Roberto Ceniceros wrote a great piece this week on R&I regarding opioid-induced hyperalgesia.  This is a phenomenon observed in some patients on long term opioid therapy in which the opioids actually increase the sensation of pain.

Among prescribers unaware or uneducated on the topic, the patient's legitimate report of increased pain can lead to increased dosage of opioid analgesics, which thus leads to increased pain.  This creates a vicious cycle that can lead to significant adverse effects, including dependence, addiction, and potentially death.

Dr. Marcos Iglesias, medical director for Midwest Employers Casualty, said, "A lot of claimants who are on high doses of opioids are still in a lot of pain.  A big reason for that is the opioids.  Once they are weaned off the opioids, they feel much better and their pain will actually decrease.  So ironically, one of the ways to help their pain is to take away their painkiller."

Add to this recent findings that weaning opioids, even high doses of opioids, in the outpatient environment is not only possible, but leads to decreases in pain scores, depression scores, etc. and we can begin to see the absolute necessity of questioning the medical appropriateness of high dose chronic opioid therapy.

The graphic below is from the CDC.  I wonder to what extent this cascade of negative clinical and social consequences started with an otherwise well-intentioned physician failing to notice signs of opioid-induced hyperalgesia.  

You didn't need any more evidence than you already had to question the medical necessity of long term opioid therapy.  Nonetheless, if you haven't already, it's time to focus on ensuring injured workers under your stewardship aren't being harmed by the very drugs intended to help them.  

Michael 

On Twitter @PRIUM1

Getting past cynicism

For my younger readers who did not understand the Star Trek references in my introductory blog, I will footnote this time!

Objectivity and logic is very important when making medical and financial decisions.  Obviously the TV commercials that give you not one, but two, of the widgets if you buy in the next 10 minutes count on your impulsive nature overriding your logical assessment as to whether you really need the widget.  But the last thing a patient, or Payer, needs is for a treatment plan to be based on the impulse of treating a subjective complaint without thoroughly, logically, and objectively evaluating every potential option available, starting with (and possibly returning to repeatedly) the plan that has the best outcomes with the least side effects.  In this case, you need the capacity of Mr. Spock's dispassionate assessment.

But, on the other hand, a passionate approach to decisions and the way one lives life is also very important.  Not to the extent that some sports fans go, like the Giants fan that was beaten by Dodgers fans after the baseball season opener in 2011.  But the intense desire to do the right thing, sometimes when the right thing is not logical or easy.  In this case, you need the ability to move forward against all odds, like Captain Kirk.

In our Work Comp industry, the easy claims (slight injury, patients motivated to return to health and work quickly) are not the ones that occupy the time of the various stakeholders.  Instead, the claims where the patient is unmotivated, or the treating physician is a “bad actor”, or the plaintiff’s attorney is litigating everything … those are the ones that occupy the most time, create the most frustration, and can create an attitude of cynicism or ambivalence.  Then it is easy to lose both objectivity and passion, which reduces the ability to make good decisions.

Our organization received a compliment (at least from my perspective) yesterday from one of our clients.  When asked why he was impressed (and he does not impress easily), the immediate response was “because you care”.  Our passion to do the right thing, clinical for the patient and financial for the Payer, was evident to him during our interactions.  The challenge, for all of us, is to maintain both objectivity and passion even though our daily circumstances might try to steal that away.

In this together – Mark Pew

On Twitter @PRIUM1

PDMP: From Data Collection to Meaningful Action

PDMP's:  Transitioning from data collection to action

There has been a lot of discussion regarding Prescription Drug Monitoring Programs (PDMPs) lately and the steps that states (other than Missouri) are taking to implement programs and collect prescription data.  This is a great step in the right direction and we at PRIUM believe that data collection is instrumental in addressing the opioid epidemic.  But this is only the first step and almost every state has a long way to go.  In order for participants in the workers' compensation system to make a difference, stakeholders are going to need to push state legislatures to demand action in relation to the data being collected.

Kentucky is moving in the right direction.  Kentucky is one of only four states in the country that have a requirement for physicians to consult the PDMP prior to writing certain prescriptions (NY, TN, and MA are the others).  The state is also using that data to identify providers that may be improperly prescribing.  So far, 46 providers have been identified and reported to the KY Medical Board, resulting in 23 sanctions.

Washington State is sharing PDMP data with the Department of Labor and Industries to inform claims managers and assist in appropriate treatment.  They have initiated an Early Opioid Intervention Pilot with the goal of identifying injured workers' who were being prescribed opioids prior to their workplace injury.  3-4% of new claims each month are falling into this category, representing between 350-500 new claims each month.

Additionally, last July, the Dept. of L&I used data collected through the state PDMP to inform and give insight to the update of their Opioid Guidelines.

Kentucky and Washington have begun the conversion from mere data collection to meaningful action, and both States are reporting significant positive results from their efforts.

Which states will be next?

Michael
On Twitter @PRIUM1

Zohydro: Politicians, Doctors, and Common Sense

In recent months considerable controversy has surrounded the release of Zohydro – a newly patented form of hydrocodone from drug maker Zogenix Inc.  The new formulation was approved by the FDA for sale in the United States last October despite objections by the FDA's own advisory committee (which voted 11-2 to not approve the drug).  Since that time:

• A coalition of addiction treatment experts has urged the FDA to revoke its approval of Zohydro
• Congressmen and Attorneys General from 28 states and the District of Columbia have asked the FDA to reconsider its decision
• Governor Deval Patrick of Massachusetts declared a public health emergency to ban the prescribing and sale of Zohydro (which has since been stayed by a federal court judge)
• A New Hampshire Senate committee introduced legislation that would impose an 18-month moratorium on Zohydro
• Vermont Governor Peter Shumlin devoted his entire annual address to the “full-blown heroin crisis” in the state of Vermont.

While approval and sale of Zohydro is meeting with popular and political objection, medical opinion on the new drug is less congruous.  Zohydro doesn’t contain acetaminophen (like many of the most popular forms of hydrocodone-containing products that preceded it).  Many physicians look to Zohydro for an important clinical tool that might serve as relief for those at risk for liver toxicity and suffering from severe pain.  This is a valid clinical view. 

However…

Annual ED visits resulting from acetaminophen overdose: 56,000

Annual ED visits resulting from opioid overdose: 500,000… 10X that of acetaminophen.

Annual hospitalizations from acetaminophen overdose: 26,000

Annual hospitalizations from opioid overdose: 1,300,000… 50X that of acetaminophen.

Annual deaths resulting from acetaminophen overdose: 450

Annual deaths resulting from opioid overdose: 16,000… 35X that of acetaminophen.

People addicted to acetaminophen: 0

People addicted to opioids: millions

PRIUM has begun to see Zohydro in our peer reviews.  We've only seen a few scripts, but it's clear in the cases we've seen thus far that acetaminophen concerns are not the driving factor for the doctors prescribing the new drug.  Rather, it seems they're simply trying the market's newest opioid analgesic. 

Is the safety profile of Zohydro, due to its lack of acetaminophen, sufficiently compelling for us to ignore the inclusion of yet another opioid in the midst of this epidemic? 

Michael
On Twitter @PRIUM1

Unintended Consequences: Utilization Review and Litigation

It took about a year, but that's about how long these things usually take.  When SB 863 went into effect, many parties, including PRIUM, expressed some concern around the IMR process and whether or not it  would stand up to the challenges that we knew would come.   Claimant attorneys in the state have been busy and we are starting to see the expected results.

In Dubon v. World Restoration, Inc., (cite) the WCAB took back much of the authority that the legislature tried to take away.  UR determinations that suffer from a material procedural defect that undermines the integrity of the utilization review determination no longer fall under IMR's jurisdiction.  Those determinations will now rest with judges and as the WCAB so eloquently put it "a prudent employee" that wishes "to challenge the [...] procedural validity of a UR decision before the WCAB ... will also file a timely request for IMR.  If the employee elects not to file ... the employee does so at his or her own peril".

What does this mean?  We are going to see more requests for both IMR and hearings, as "prudent" attorneys will want to cover all bases, and we will see additional confusion around what constitutes a material defect.  Another case decided last week brought this point up as well.

In Weilmann v. United Temporary Service, the WCAB held that UR decisions must be signed by the reviewer and that they must be provided sufficient information necessary to make the determination on medical necessity.  In this case the insurance carrier failed to provide the AME report to the UR reviewer, now whether or not the burden rests on the physician requesting the treatment or the insurance carrier is a post for another day.  Based on the totality of the circumstances in this case, the UR decision was found to be invalid and the treatment request should be granted (if the judge finds it to be reasonable and necessary).

Lastly, and potentially most impactful, is Stevens v. State Compensation Insurance Fund, being heard by the First District Court of Appeals, in which Ms. Stevens, who is 100% disabled, was denied medical care.  The underlying argument is the one that we were most concerned with from the outset of SB863 and the IMR process: the inability of the injured worker to make an appeal following an IMR denial.

It's been a busy few weeks in California and I don't expect it to slow down.  We will be anxiously watching to see what's next.

Michael
On Twitter @PRIUM1

Zohydro: Let the Lawsuits Begin

Zohydro is here.  The first and only analgesic with hydrocodone as the sole active ingredient, comes to us in non-tamper resistant formulation.  As expected, the debate has been heated.  What may not have been expected are the moves some state leaders are making in attempts to preempt the drug's potentially negative impact. 


A couple of weeks ago, Massachusetts Governor Deval Patrick took a particularly bold step when he declared a public health emergency and, among other things, prohibited the sale of Zohydro within the state. 


Zogenix, maker of Zoyhdro, is now suing the Governor to block the ban. 


FYI... Zogenix stock is up 62% from this time last year, though down significantly from its high in late February (when it was up 210% from April 2013... before the public health community, state and federal politicians, and right-minded doctors starting pushing back.  Since hitting its high of $4.93 on February 25, the stock is down 47% at $2.60 as of this afternoon). 


So who wins?  A well-intentioned governor trying to protect the citizens of his state?  Or the pharma company with a new drug that has FDA approval?


Michael
On Twitter @PRIUM1

Studies You Should Know About

Here's a quick run down on recently published and forthcoming studies to which you should be paying close attention:


On the heels of the recent Kaiser study that showed the safety and effectiveness of outpatient weaning, even among patients on high doses of opioids, comes another (slightly larger) study with similar results.  A study presented at the 35th annual meeting of the American Academy of Pain Medicine showed "patients receiving high doses of opioids show no worsening of pain scores or aberrant drug behaviors after significant dose reductions compared with patients who do not have dose reductions."  Lead author Dr. David DiBenedetto from the Boston Pain Care Center noted, "Despite significant reductions in their opioid doses and the fact that doses were often actually increased in the control group, the outcomes in the areas of perceived functionality and aberrant behaviors were no different between the two groups."  The minimum starting dose of the high dose group was 200 mg MED per day and the average was 508 mg MED/day.


Once again... we can do this... we can do it on an outpatient basis... we can relieve pain, increase functionality, and improve health... we just have to lower the opioid dose. 


My last post on the new ACOEM guidelines highlighted the fact that the longest, placebo-controlled study of opioid use lasted 4 months.  Obviously, nowhere near good enough.  Keep an eye out for the forthcoming POINT study (the Pain and Opioids In Treatment study).  A quick overview:


"The Pain and Opioids In Treatment (POINT) study is a unique study that aims to: 1) examine patterns of opioid use in a cohort of patients prescribed opioids for chronic non-cancer pain (CNCP); 2) examine demographic and clinical predictors of adverse events, including opioid abuse or dependence, medication diversion, other drug use, and overdose; and 3) identify factors predicting poor pain relief and other outcomes. Methods: The POINT cohort comprises around 1,500 people across Australia prescribed pharmaceutical opioids for CNCP.  Participants will be followed-up at four time points over a two year period. POINT will collect information on demographics, physical and medication use history, pain, mental health, drug and alcohol use, non-adherence, medication diversion, sleep, and quality of life."

This could provide very helpful data.

Finally, CWCI is studying the potential impact of a Washington/Texas-like closed formulary on workers' compensation prescription drug costs in California.  I'll be fascinated to see the results.  I believe two things are nearly certain:
1) The potential savings number will be huge.
2) The fight over this in Sacramento will be even bigger. 

Michael
On Twitter @PRIUM1