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A Physician-Driven Solution…Ethical Challanges in Pain Medicine

John Graham, seven-time winner of Worlds Biggest Liar competition

Dr. Danielle Perret and Dr. Charles Rosen have published an article in this months Pain Medicine that is worth the time it takes to read it. It is almost 10 pages long and it adresses nicely issues such as “frequent application of interventional techniques “ , the Charite Disc, the fact that the US uses 99% of the worlds hydrocodone supply, ultrashort acting fentanyl, and most importantly, conflicts of interest in pain education and research in the context of industry support. They also make a case for a potential solution. Dr. Rosen is one of the founders of the Association for Medical Ethics (AME).

AME is an organization:

“intended to promote full financial disclosure in the practice of medicine and research. Namely, the association recognizes that the patient and the practicing physician have a right to realize if a drug or device manufacturer paid the authors of a positive study; the amount and nature of finacial compensation should also be transparent.”

The authors state that the AME is the only organiaztion – as well as Website – that lacks industry funding. They descibe the obvious advantages of such an organization. I had never heard of this organization before but the concept seems quite appealing. Their Website is rather brief but worth a visit. It costs nothing to join except declaring that you will not accept money from any industry source. They do evidence reviews on their site similar to Cochrane reviews that were fun to read- especially the IDET material.

In discusssing interventionalist’s they underscore the need for competency assessment of many poorly trained interventionalists who are out there practicing, the paucity of evidence in this field, and the incentive for physicians to overuse potentially lucrataive procedures. I completely agree. I am sure many of us have been horrified by the abuse we witness in our field. I recently saw an elderly man who relocated to New Hampshire (where I practice) from Florida who wanted me to provide him the epidural injections that were so useful to him in Florida. I obtained a copy of his procedure notes and could not believe that the “interventionalist” was performing four transforaminal injections at a time for this gentleman with a nonoperated and otherwise normal back. A single interlaminer injection would be the indicated procedure at probably one fifth the cost and with only a fraction of the risk!

I have momentarily wondered why pharmaceutical companies came out with Onsolis (fentanyl buccal soluble film) and Fentora (fentanyl effervescent buccal tablets) when Actiq (fentanyl buccal lozenges) was already available. Since as far as I can tell there is no clinical advantage of one over the other, the answer can only be money. I have seen patients presenting in my office with chronic pain using these incredibly expensive drugs for no good reason. I have used Actiq twice that I can recall in nonterminal patients- but both times with good reasons. Of course, the data supporting the use of these drugs comes from pharmaceutical manufacturers. Does breakthrough pain even occur in patients with chronic pain? Is ultrashort acting fentanyl more or less safe then other oral opioids? Are there side-effects unique to these drugs that we are as yet unaware of? Is there an unbiased individual who can answer these questions? We know from reviewing the Infuse (my last post) data that pharmaceutical company funded data is biased; anybody that accepts funds from device or drug manufacturers is biased; and there can be no doubt about that (unless you are a choirboy- see my last post).

In their conclusion, these authors state:

“Medicine should return to being independant, unbiased, and guided only by what is best for the patient, not necessarily what the patient or the medical manufacturers want”.  

We will not quibble with the fact the the device and drug manufacturers are responsible to ther shareholders for profit as their primary motivator. I believe that in general they are interested in patient well-being and safety as well but this concern can easily be subjugated by an overwhelming and severely biased assessment of the value of their product. I also believe that millions or billions of dollars is incentive enough to create criminals out of doctors or device and drug manufacturers. The stakes are so enormous that lying and deceiving for dollars becomes a very real option. To read about the Cumbria Worlds Biggest Liar competition select the following link.

The Choirboy Defense

In an unprecedented move, a group of distinguished and courageous spine specialists have publicly criticized the work of their colleagues who published data in support of a bone graft substitute, recombinant human bone morphogenetic protein-2 (BMP), trade name, Infuse. The criticism appeared in a full issue of The Spine Journal and demonstrates that the researchers, supported with surprisingly large amounts of money from Medtronic, the maker of BMP, both overstated the benefit and understated the risks.

BMP is used in an estimated 432,000 spinal fusions per year and accounted for revenue of approximately $900 million for Medtronic in the most recent fiscal year. In 12 of the 13 original studies supporting Infuse, the median known financial association between the authors for each of the 12 studies and Industry was found to be between $12 and 16 million. One of the sponsored investigators has reportedly received $20 million in royalty payments from Medtronic in connection with patents some of which pertain to BMP. This physician stated, as reported in the New York Times, despite this, that he did not have  a “direct financial interest in the success of Infuse or Medtronic”.

Eugene Carragee, Christopher Bono, and others described in elegant detail, in a manner that can be described as a combination of clinical excellence, scientific acumen, disappointment in the lack of integrity of their colleagues and investigative reporting, the events leading to their actions (Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. The Spine Journal 11 2011:471-491).

Preclinical animal studies of BMP, which causes bone induction and helps improve fusion rates,  demonstrated adverse events that were diverse and species specific including an increased risk of cancer. A series of Industry sponsored clinical trials then ensued with no adverse events noted in 780 patients. That is correct: zero adverse events. This data placed the risk of adverse events for BMP less than the risk of commonly used antibiotics or anti-inflammatories. Although the drug was initially indicated for only a small and specific population of patients, generalized use  increased dramatically to the point that 50% of all ALIF’s were getting Infuse. Remember, virtually no complications or side effects reported in clinical trials plus possible increased fusion rates and operative success! Why not use it on all spinal fusions? ”Industry” sponsored clinical trials followed documenting the usefulness in a wider range of clinical applications. Simultaneously, and you can’t make this up, Industry sponsored trials reported complication rates as high as 70% associated with the gold standard for fusions, iliac crest bone graft harvesting. The use of BMP of course increased. In June 2008, the FDA reported life threatening complications associated with the use of BMP

 ”These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports described difficulty swallowing, breathing or speaking.”

“When airway complications occurred, medical intervention was frequently necessary. Treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomy, and most commonly, second surgeries to drain the surgical site.”

At the same time, the Justice Department was investigating Medtronic and three Medtronic employee whistle-blower lawsuits sought damages for research fraud and misconduct.

The risks of BMP include carcinogenicity, urinary retention, spine and muscle pain, retrograde ejaculation, delayed infection, etc. There may be no true benefit at all of the drug and there were possible study design biases against the control groups making iliac crest harvesting appear worse than it actually is.

In an accompanying Editorial Carragee, et al (pp 463-468) discuss “A challenge to integrity in spine publications” and describe The Choirboy Defense versus a threat to scientific integrity. Wikipedia defiens Choirboy as follows: As a derisive slang term, it refers to a do-gooder or someone who is morally upright

…some contend that there is no systematic problem, that is the “choirboy defense.” We are an honest profession; our integrity is unimpeachable; our ethical standards are not in doubt; potential conflicts of interest are only “potential”; the fact that the speaker or author may have millions of dollars riding on device royalties or consulting agreements with the sponsoring company is immaterial: that another author gets millions in royalties from the only on-label approved device for rhBMP-2, could never impair his objectivity in assessing its safety or effectiveness. Outside the echo chamber, however, much of this rhetoric fails to pass the test of minimum credibility.

What we are talking about are researchers lying about there findings for money despite the fact that patients can be seriously harmed. This is a problem that goes beyond spine medicine. We could just as easily be talking about IDET. Thanks Gene, Chris and others for your work. Hopefully this will be the beginning of a reemergence of a return to honesty and integrity among physicians. I don’t really know if there is much hope for industry.

AAPM Annual Meeting- Day Three

The meeting begins. I was most looking forward to the Richard Rosenquist v. Laxmaiah Manchikanti title bout scheduled for 10 rounds to debate the American Pain Society’s Guidelines for Interventional Procedures for Low Back Pain. You can view a pretty close approximation of Dr Manchikantis comments on four youtube videos from June 2010 when he debated Roger Chou (his videos available too) on the same topic. Roger along with Rick led the writing of these guidelines and Lax as the founder of ASIPP has soundly criticized the Guidelines. I am biased in my following of these debates in that I worked with Roger (and Perry Fine as co- Chair of the APS Chronic Pain Opioid Guidelines Committee) and understand and respect the rigor associated with Rogers approach to Guidelines. I believe the APS Guidelines are a useful tool to help physicians decide how to select appropriate interventions and I agree with their recommendations. The problem is with the interpretation of those recommendations by payers. Their bias is to not want to pay for anything if they can get away with it and the universal misinterpretation of what Evidence Based Medicine is.

EBM means using the best available evidence to help guide clinicians judgement when selecting treatment options. The absence of evidence does not mean the absence of efficacy, I have heard so many people say, and which is clearly true. The key and often overlooked part of this equation is that clinicians judgement is the ultimate arbiter.

A simple example is the current controversy over the use of vertebroplasty for vertebral compression fractures. I don’t want to get into the minutia but what we have is a flawed paper published in a distinguished journal (pretty sad but common occurrence) stating that vertebroplasty is not useful for VCF. This, in the face of the fact, that all of us who do the procedure or who have colleagues who do the procedure, have seen the most gratifying and remarkable outcomes from the procedure. Hospitalized, otherwise untreatable patients in agony, cured by this procedure. Yet this paper creates difficulty, and denials, for what is literally a life saving intervention. The decision to use this treatment should not be taken away from the physician.

Another example is the use of Epidural Steroid Injection for axial low back pain in a patient with spinal stenosis who has had a fusion. There are three reasons not to do n ESI. The first is that these injections are not usually indicated, based on our best literature, for axial low back pain. They are not felt to be useful in patient post surgically. And they are not believed to be useful in patients with Spinal Stenosis. I have many patients who fall into this class for whom I do an ESI every few months and for whom it is the only treatment that they can tolerate and which helps. Clinicians should weigh the strength of the literature and use good clinical judgement in selecting treatments. The ability to help patients in pain should not be taken away by insurance or workers compensation companies.

Just a final plug for recognizing bias. Research funded by workers compensation companies is unequivocally biased and should be viewed only in that light. It is a sad state of affairs that the NIH is so underfunded that they cannot support research that is so crucial to relieve the suffering of our patients and that special interest groups with deep pockets can determine who gets what treatment when they do not have the patients interests at heart.

The Rosenquist v. Manchikanti bout was skillfully fought by both parties. There was little physical contact between the opponents and I believe the match went to Rosenquist in a split decision. I suspect Way Yin who was a judge (also biased as the President of ISIS) at ringside gave more points to Manchikanti.

AAPM Annual Meeting- Day Two

Day two and I have no meetings to attend. Off to the Smithsonian. I had been on a conference call yesterday with Steve Passik and Charles Argoff and Steve reminded me that he had been an art history major in college and highly recommended the Canaletto exhibition at the National Gallery. (I think Steve has left Memorial but I didn’t have an opportunity to discuss with him- their loss) First of all, the museums are free (not really I have been reminded because we do pay taxes). At least you don’t have to cough up any cash at the door. The volunteers and everyone at the museum were friendly and knowledgeable. I especially enjoyed seeing the guards holler at the teens who felt they had to jump on the “moving sidewalk” (which was rather spongy, kind of like a trampoline) and seemed always to have to handle the sculpture.  I must admit that there is a magnetism to the sculpture that does make you want to touch it. There were two exhibits, Gauguin and Canaletto.

The Gauguin exhibit was incredible.  The use of color, the subjects, the “post impressionism” images, of this late 19th and early 20th century artist were just mesmerizing. Many similarities between Van Gogh and Gauguin. They painted together in Arles for a number of weeks and reportedly did not get along. Gauguin himself it seems had his weaknesses. He died at the age of 54 of syphilis, alcoholism, and a “dissipated life”, while awaiting a prison sentence.

Caneletto painted in the 18th century and his work consisted largely of images of Venice which he sold to tourists at the time. This show contrasted his work with contemporaries and competitors for the tourist market such as Michelle Marieschi. Paintings by the different artists of the same subject but with differences in detail, perspective, lighting, and color were easily appreciated even by someone like myself without an extensive background in art. The museum visit was memorable and I highly recommend it. Please note that the reviews above come from a doctor and not a Bert Fichman doctor who is an artist himself. Feel free to criticize or add to my comments.

I had also vowed to get to the gym every day I was at the convention and I made it again today. Ran into Bert Ray down there and he looks great and is as personable and warm as ever. Bert and I know each other for at least a couple of decades and I always think of Lynn Johnson whenever I see him. Lynn was a Mentor of mine from Boston and was very active in the AAPM early on. I lost track of him many years ago and no one seems to know where he is or what he is doing. Dinner at Bond 45 in National Harbor with Jay Kazalski who works up in Maine and David Nagel who is my friend and colleague also from New Hampshire. The restaurant was expensive and “okay” but not great and our waiter seemed a bit annoyed that we were actually there.

Can I Ask You a Quick Question

As a pain specialist, I get curbsided a lot. In Infectious Disease though curbsides actually outnumber formal consults. Paul Sax, an ID guy from BWH in Boston speaking at the Internal Medicine for Subspecialists Course in Boston 2 weeks ago, added that ID is the most frequently curbsided of all the medical specialties. Curbsides may account for 22% of the workload of ID specialists. Dr Sax cited what makes a good consult: not an emergency; straightforward history; decision does not require face-to-face contact with patient, and; patient is comfortable with evaluating clinician and doesn’t want to seek ID care specifically. So far, criteria sound like they fit Pain Medicine pretty well too. I will present now what I consider NOT to be a good Pain Med curbside consult.

“Hi Gil. I have a 35 year old patient who kind of scares me. I’m not sure why, but he presented in my office asking for me to write his methadone prescriptions for him because his usual doctor is retiring. He’s using 80 mg of methadone every 4 hours for his back pain. He says it’s not working so well anymore and wonders if he can get it switched to oxycontin. He has been treated for alcoholism in the past but hardly drinks at all now and only smokes marijuana. What should I do”?

Dr Sax then conducted a real-time  survey of the audience and asked if those who got curbsides cited the curbsidee’s name in the medical record and I was stunned at the number of doctors who did. The risk-management folks at BWH have advised him to put a boilerplate statement in the charts of all the patients he gets curbsided on. Very interesting.  He had a few comments about lawyers he interspersed into this discussion, none of them complimentary.

He was pretty cynical about lawyers and he wasn’t especially kind to surgeons either. He cited an unknown surgeon as telling him:

“The less evidence there is, the more antibiotic I give”.

I believe it and hate to say there are times I don’t disagree with it. Dr Sax did a very good job and he was very funny. For extra credit, he described a few TRUE cases that he had seen.

1.   A woman sees him because while feeding a wild racoon with a baby bottle, she took some sips from the bottle to see if she could increase the flow. Should she get rabies treatment?

2.   A man is climbing  a tree with his 10yo son and notes some sticky material on the back of his neck. He’s convinced it is from squirrel urine or feces and demands rabies vaccination.

3.   A child finds a new piece of upholstered furniture in her dollhouse. After playing with it for several hours, she brings it to her mother who identifies it as a dead bat. She seeks rabies vaccination for herself and her daughter.

4.   And the best for last: A woman knocks down a bat in her house with a tennis racket and her husband pounds it with a baseball bat. They bring it to the State Lab for rabies testing but the lab folks are unable to find any brains at all. They come to Dr Sax asking if they should move out of their house because of the risk of aerosolized rabies virus.

Great course.

Update in General Internal Medicine for Subspecialists

Who says you can’t teach an old(er) pain doc new tricks. So here I am (was) at the Update in General Internal Medicine for Subspecialists course at the Fairmont Copley Plaza in Boston. What a great week. I usually attend pain meetings and I love them but I know most of the material, speakers, etc. This course was new material, new speakers, and was like going back to medical school for a week (only much better because I ate lunch and dinner in the Oak Room). I was going to Post during the meeting but found I couldn’t keep up if I did. I learned this right away. The first lecture was Ischemic Heart Disease by Eric Isselbacher. He was an engaging, knowledgeable, and well prepared speaker and here are some Pearls from his talk.

1.   ASA benefits everyone whether it is for primary treatment of coronary heart disease or secondary prevention. Enteric coating effects bioavailability and if you use EC product, increase dose from 81 mg/day to 162-325 mg/day. Take an aspirin.

2.   CHARISMA: Clopidogrel (Plavix) and ASA v. ASA alone for prevention of atherothrombotic events. No difference between groups for stroke, MI, or CV death and rate of death in subgroup analysis was higher for Plavix group as was the rate for moderate bleeding (but not severe bleeding-IC hemorrhage). So don’t just start taking Plavix. Awesome acronyms for studies in this field!

3.   Statins. Target LDL gets lower and lower (was <100 in 2001). New target is 70! Clinical benefits far exceed the angiographic improvements. Statins seem to suck the lipid right out of plaques and create stable plaques out of vulnerable plaques. They also reduce inflammation and improve endothelial function. If you have CHD, you should take Statins to lower your LDL to 70.

4.   Homocysteine. No benefit to reduced homocysteine levels. Similarly, no benefit Vit C, Vit E (NORVIT, HOPE, SEARCH, SECURE trials). But eat 2 servings of fish/week or 1g supplement daily. Omega-3 fatty acids reduce the risk of MI and sudden cardiac death as a secondary prevention (post MI) strategy. Jury is not in on primary prevention yet.

5.   Take an ACE inhibitor if you are high risk (DM, vascular disease, etc)-  Reduces MI risk by 20% and CV mortality rate by 26%). HOPE, EUROPA, PEACE studies.

6.   Prescribe Exercise

Some very funny comments as well. When asked “should I ask my orthopedic surgeon if I need a hip replacement”, the speaker responded, “Don’t ask a barber if you need a haircut”. And Ciaran Kelly who spoke on GERD noted “you’re only as young as your weakest sphincter“.

Learned a lot and laughed too. Can’t beat it.

Pain Medicine: Repairing a Fractured Dream

Jane C. Ballantyne, MD, FRCA

 Quick on the heels of Allen Burton’s opioid post comes this Editorial just published in Anesthesiology written by my friend and colleague Jane Ballantyne who is in transition relocating from The U of Penn Pain Medicine Center to the University of Washington Pain Center. Those who know Dr Ballantyne recognize her as one of the great thinkers and leaders in our field. She is incredibly bright, passionate in her beliefs, articulate, and thoughtful. I cannot do better than to quote

“How many multidisciplinary pain centers have to be closed, and how many academic pain programs have had to focus on interventional approaches to the near exclusion of all else to meet the production metrics expected by their hospitals and bean counters. The model for economic survival is not the model for good care”.

There is much room for discussion here between “interventionalists” and the multidisciplinary pain center caregivers. I will not criticize interventionalists who may rely on others, less highly remunerated , to provide the pharmacological, behavioral, and physical medicine care our patients need. Nor will I chastise the academic pain medicine leaders for succumbing, so often, to the pressures of the changing landscape of academic medicine, possibly in the interest of maintaining their salaries. I have been slowly watching this happen for 20 years now and I deserve as much blame as anyone else.

Dr Ballantyne states “This is not intended as a message of doom and gloom”. She is optimistic. Maybe that is too strong a word. Maybe hopeful. Once before, in the 1940′s or 50′s, pain medicine died as a specialty because of a lack of commitment of institutional leaders to support good pain care; a lack of science supporting our ability to actually help people; and lack of adequate reimbursement to pay for good pain medicine. Roy Van Dam wrote about this but it was so long ago I was unable to locate his paper, written so long ago- maybe someone else can find it. Our institutions want procedural pain medicine. I have been waiting my whole career for a big scientific  discovery in pain medicine and all I see is another opioid, anticonvulsant or antidepressant. There is inadequate reimbursement for everything in pain medicine except for procedures. Dr. Ballantyne may be more optimistic than I am. History may be repeating itself.

We can only do our best to try to help our patients in a very limiting and unsupportive environment. We can only speak out when we see our patients access to care threatened. Anesthesiology based pain medicine salaries, according to the latest MGMA surveys, are declining.  Dr. Ballantyne concludes by stating:

“I would like to be able to hold my head high and say that what I am doing, and what my specialty is doing, is helping to relieve the burden of chronic pain”.

I think we all agree. Leroy D. Vandam, M.D., once quoted Alexander Slater, M.D., who stated that: “Without vision and research, the professions die.” The model for economic survival is not the model for good care.  I am worried about the future of pain medicine. “

AAPM Annual Meeting

 March 24 – 27, 2011 in National Harbor, MD
It’s that time again. I get very excited about attending the AAPM annual meeting. Firstly, I am presenting along with Michael Ashburn, Martin Cheatle, and Fred Davis on the use of electronically acquired outcome data to be used as a tool to improve patient care.  I assure you, it will be a scintillating presentation. Secondly, it is close to DC. I love DC. The Smithsonian, great restaurants ( The Capital Grill may be the best Steakhouse in the US if you can afford it).  And lastly, it is chance to see all my friends, and an opportunity to hear and see learned and entertaining speakers. It’s much better than watching Steve Tyler on American Idol!

 The meeting is in National Harbor, MD. National Harbor and the Gaylord National Hotel & Convention Center is located just 15 minutes (8.2 miles) South of the Capitol, White House and the Mall. It is in Maryland, and is just east of Alexandria, VA (across the river). With a variety of transportation options available, visiting the Capitol should be quite easy.

Looking through the agenda many items stand out. I look forward to hearing what Perry Fine, our President Elect has to say. Perry, as many of you know, is an erudite man with an engaging smile and sense of humor. He has many interests and is an accomplished musician and leader. Zahid Bajwa is Co-Chairing the Essential Tools Sessions which are always so useful. Congratulations to Sunil Panchal and Tim Lamer for attracting the American Medical Associations President-Elect Peter W. Carmel who will speak about health care reform and Vice Admiral Regina Benjamin, U.S. Surgeon General, who will address pain care reform. Very cool!

I look forward to hearing more about Battle Field Pain Management from Colonel Chester C. “Trip” Buckenmaier, III and also about what is happening with the VA from Rollin “Mac” Gallagher. The military pain research that these leaders are conducting is groundbreaking! I really want to see Richard W. Rosenquist and Laxmaiah Manchikanti put on the gloves and offer differing views on the APS Low Back Pain Guidelines. They are both committed to their often opposing views, extensively knowledgable about the material, emotionally involved, and talented debaters. This one should not be missed! Medical Marijuana, Cancer pain and Opioid Abuse, REMS, Management and Payor Issues are all timely and enticing topics. Plus there is an opportunity to plumb the depths of the minds of the great thinkers of our field: Lynn Webster, Allen Burton, Tim Deer, Sean Mackey, Alex Cahana, Leonardo Kapural, Steve Stanos, Charles April, John Rowlingson, Ben Rich, Larry Driver, Aaron Gilson, Scott Fishman, Albert “Bert” Ray, Steve Passik, Ajay Wassan and Yu “Woody” Lin form the NIH. What a line-up. Please forgive me for leaving out so many other talented individuals.

It is really a wonderful meeting. I am friends with almost every person I’ve named in this post. If you are new to Pain Medicine or if you are not new but want to get more involved with your colleagues, come to the meeting, volunteer for a committee, meet new friends and in a decade or two, it will seem like a family reunion. See you in DC.

Opioids, Opioids: To prescribe?, to wean?, to increase?, to screen?: When did it all get so crazy-complicated ???

 

Allen Burton, MD

 This is a guest post from Allen Burton, MD. Dr. Burton is the Chair, Department of Pain Medicine, at MD Anderson Cancer Center in the Great State of Texas, USA.

 “To prescribe or not to prescribe (COT), that is the question…”

 A perfect storm has developed involving prescription opioid medications.  Throughout the last few decades there has been an increased awareness of untreated/unrecognized pain with subsequent efforts enlisting doctors to assess and treat pain more aggressively.  This frequently translated into increased prescribing of opioids.

More than 10 years ago, both the American Pain Society and the American Academy of Pain Medicine wrote formal position statements endorsing and formally legitimizing the prescription and use of chronic opioid therapy (COT) for the treatment of pain. 

These efforts have succeeded in increasing the assessment of pain, and in the prescribing of opioids-both by specialists and primary care providers.  An editorial in Pain put it this way “Increased opioid prescribing:  A reason for celebration- or alarm?  Are we flying blind.”  As a result of the increased availability of opioids, many serious, unanticipated problems have arisen.  These problems include an explosion in non-therapeutic opioid use. Deaths from prescription opioids currently exceed deaths from heroin and cocaine overdoses. A recent JAMA publication found hydrocodone to be the drug of choice for 9th graders experimenting with drugs-over marijuana.  The United States represents 5% of the world’s population but consumes 99% of the world’s hydrocodone production.

In Houston, where I practice, “pill-mills” have run amuck further complicating the issue. (See article from today’s Houston Chronicle
http://www.chron.com/disp/story.mpl/headline/metro/7385695.html
)  These are basically store front sham-“medical practices” which sell prescriptions for cash; the most popular combination being vicodin/soma/xanax- sometimes called “the holy trinity” or “the party pack.”  The pill mill problem has led to massive outpouring of these medications into the streets with predictable results- increased use/abuse by drug experimenting adolecents/teens/adults…with overdoses fairly commonplace.  It seems that the reputation of the “pain clinic” is in the gutter as the specialty of pain medicine too often gets lumped in with “pill mills.”

The pain community in Texas worked, via the Texas Pain Society (www.texaspain.org)  with the legislature last session to craft “pain clinic” rules for clinics that largely prescribe controlled substances as part of their practice.  This upcoming session, we at the TPS are trying to strengthen and enhance Texas’ prescription monitoring program to enhance a physician’s ability to scrutinize a patient’s prescriptions real-time, not relying on patient report.  The role of urine drug screening needs clarification; third party payors, including medicare push back on paying for routine screening, while medical boards mandate this.

Finally, it becomes increasingly challenging to seek clarity on the basic medical question of efficacy- are chronic opioids indicated to treat chronic pain?  Do they improve function? Improve pain quality/intensity/other features?  Improve psychological well-being?  Some good quality studies show that they do improve pain in refractory chronic pain conditions- for example for shingles pain from 2002, Raja and colleagues showed good pain relief and low side effects for 8 weeks duration (Raja SN, et al.  Neurology 2002; 59(7):1015-21).  Other studies show disappointing results in the long term (Eriksen J, et al.  Pain 2006; 125(1):172-79).  In my own practice, I remain confused over the role of COT, but am beginning to see a little clarity.  The issue of chronic opioid prescribing is very polarizing-within the pain community- which “team“ are you on “opioid advocates” or “opioid nihilists?”  I would like to be on the side of the truth- but where can I find that ??  There is so much bias in so much of the information we receive. 

As a practicing pain physician, I have many duties: to relieve pain and suffering in my patients, to cause them no harm, to practice safe medicine for the community at large-among them.  Personally, my goals include staying out of trouble from a regulatory perspective-while “doing the right thing” for my patients.  I have evolved, in the current climate to a somewhat bi-modal patient population who may be candidates for chronic opioid therapy (COT).  Opioid candidates (in my opinion) include those with fairly recent injury and the likelihood of improving with multi-modal approaches- including perhaps PT/OT/injections/surgery/psychological support and/or time- still this requires a judicious approach with risk assessment, and perhaps monitoring.  Those patients developing the more refractory chronic pain conditions, in my opinion, need extensive time to try other non-COT regimens, including pharmaceutical options, in combination with extensive rehabilitation, and numerous attempts at non-COT treatment options before “settling” with COT…. These are the patients where I frequently decide that this is “the best I can do for them” at this point.  In all my patients receiving opioids, I do now require detailed risk assessment, urine screening periodically, written informed consent, and regular reassessment including “Passick’s 4-As” ((1)Analgesia, (2)Activity or ADLs, (3)Adverse effects, and (4)Aberrant behaviors or addiction).  But this is a very labor intensive process, for in many cases, very little actual functional gain, and limited pain relief- at relatively large expense- both for the medication directly, and for all the listed medical costs above.

I must say in all honesty the longer I practice, it seems that my long-term chronic opioid “success” stories have become fewer and fewer.  I think this must be the experience of others as well?    

So, to prescribe or not to prescribe (COT)… that is the question….It is a very, very difficult situation, and I am hoping for some clarity soon?!!?

Book Club

New Hampshire Books

The link above will display the books read in my “Mens Book Club” since we began. One of our members recently compiled the list and I was amazed at some of the wonderful books- Plainsong, What is the What, Team of Rivals, etc., and some of the awful books (I will resist the temptation to name them but they are on the list) that we have read and discussed. I have 6 outlets for myself that help me maintain perspective, relieve stress, provide balance, and distract me (in a behavioral sense) from what I do most of the time. They are: my wife, my dog, book club, music, friends, and time away from work.

Our book club includes at least 50% non health care providers. We never discuss medicine. Members come from a  broad range of ages. We initially would rotate and meet at each others homes but now we meet at a pub. Much more manly! We pull tables together and other customers who are used to seeing us there will occasionally deride us in what we believe is a generally friendly and sometimes demonstrative fashion. We have doctors, landscapers, writers, teachers, contractors, and a lawyer as members and anybody who loves to read is invited to attend. I would estimate that 80% of our group has either a kindle or iPad but even those with iPads read Kindle for iPad apps. The meetings rarely last more than 2 hours and we rarely have more than 2 beers. Book club is terrific!

I will not even try to describe why it is “mens only”. I’m open to suggestions from anyone who might be reading this. Let me just say there was a lovely MD/PhD student who spent quite a bit of time with us in the clinic and who has become a dear friend. She had two questions for me when she heard about the club. The first was asked quite earnestly and seriously ”Are you all Gay”? The second was asked with a  smirk, “What do you all read, Playboy”? Maybe that’s why it’s a Mens Book Club.