Tuesday, April 8, 2014

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

Friday, March 21, 2014

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

Wednesday, March 19, 2014

New ACOEM Opioid Guidelines: I Hope You're Sitting Down


Reed Group has published revised ACOEM Opioid Guidelines.  I hope you’re sitting down. 

These new guidelines are comprehensive, impressive, and should change the way you think about opioid use.  The question is no longer whether or not the medical evidence supports the view that long term opioid use is rarely appropriate.  The question now is: will your claims organization have the courage and wherewithal to use these guidelines to ensure patient safety and improve clinical outcomes?

A few highlights: 

Remember all of the discussion, education, and effort your claims organization went through to understand the concept of morphine equivalent dosage (MED) and the threshold of 120 mg MED daily, above which the risk of negative health consequences (like, for instance, death) rose significantly?  Well, after reviewing 960 references and 157 separate studies with 27 external peer reviewers, ACOEM has given us a new threshold…

50 mg daily MED. 

And they’re right.  The 120 mg MED threshold often comes too late in the treatment process to make meaningful impact and the clinical risks are observable at much lower dosage.   Here’s the proof (in laymen’s terms, the hazard ratio is the comparative or relative risk associated with a certain treatment vs. the control group.  In this case, MED at 50 mg/day suggests a death rate 3-5 times that of the control group). 


















Remember how I’m always going on about the fact that there are no studies that support the long term use of opioids for non-malignant chronic pain management?  It’s nice to put some data around that statement:  the longest placebo-controlled trial lasted only…

4 months.

Specifically, of the 67 high-to-moderate quality placebo-controlled clinical trials addressing opioid use for chronic pain, 52% lasted a single month, 12% lasted 1-2 months, and 34% lasted 3 months.  There was a single trial that lasted longer than three months (and it lasted only 4 months). 

 

You know the pharmaceutical commercials that list all of the adverse side effects one might experience while on the medication?  The new ACOEM guidelines provide a list of those side effects in relation to long term opioid use.  Ready?

Heart attack or sudden death
Fainting on standing up
Sudden death
Nausea, abdominal pain, early satiety
Constipation, bowel obstruction
Abdominal pain
Urinary retention
Impotence or reduced sex drive and erectile dysfunction, osteoporosis, feminization, reduction of muscle mass, reduced strength
Reduced or abnormal menstrual periods
Fatigue, low blood pressure, electrolyte changes
Hastening of death if cancer is present
Rash, shortness of breath, itchy skin, edema
Outbursts, inappropriate behavior, limit testing, violence, reduced impulse control
Alterations in executive function, emotional response
Slight to severe impairments if an overdose occurs
Problems thinking clearly
Headache
Increased pain sensitivity, increasing doses of opioids/dose escalation
Reduced pleasure in eating, weight loss
Seizures
Increased accident risks and unclear thoughts
Crash risk and reduced functioning
Unsafe operation of machinery, motor vehicles, motor vehicle crashes
Unsafe operation of machinery, falls
Mistaken judgment, changed interactions with other people
Altered mood, depressed feelings,
Suicidal feelings
Birth defects, miscarriage
Newborn babies of mothers on opioids go through opioid withdrawal
Reduced ability to breath during sleep; daytime sleepiness
New or increased problems with obstructive sleep apnea; daytime sleepiness
Pneumonia
Worsening asthma and chronic obstructive pulmonary disease (COPD)

I think I better understand why opioid manufacturers don’t advertise on television. 

Michael