Ohio Limits Opioid Precriptions - The Journey Begins

I have written previously about the raging opioid epidemic here in Ohio.  Attacking and reversing this tidal wave will require many weapons, resources and time.  Opioid addiction is a crafty and elusive adversary that will be difficult to vanquish.  Our battle plan will have to be nimble and adjusted over time, much as military leaders must do in actual armed conflict.

Here in Ohio and elsewhere, physicians must abide by new prescribing restrictions.  Prior to prescribing a controlled pain medicine, doctors are required to check the patients OARRS report on line, which catalogues the patient’s prescription history.  This would alert us if the patient was receiving controlled medicines from various pharmacies that the patient might not disclose to us.  Physicians and the public are encouraged to seek non-narcotic alternatives for pain relief.  If opioids are prescribed for acute pain, there is now a limit on the length of opioid treatment that is permitted.  There are exceptions which require additional physician documentation.  The above restrictions do not apply to chronic pain or pain suffered by individuals with cancer or are in hospice.  Importantly, these rules do not apply to medication-assisted treatment of opioid addiction.

Cure for Addiction Advertised over a 100 years ago.

There has been opposition to the above regulations from patients with chronic pain who are having difficulty getting their pain medicine prescriptions filled.  They are being turned away by their doctors, or told to consult with pain management physicians who have expertise in this discipline.  These specialists are extremely busy and it can be very challenging for patients to secure a timely appointment with them.  For a patient with chronic pain, this can be a vexing and agonizing situation.  And, if this patient proceeds to the Emergency Room, these physicians may be understandably reluctant to accede to a patient’s request for controlled pain medicines. 

I think and hope that these issues will sort out.  One can’t expect that new reforms will be flawless from the outset.  Perhaps, the net we are using now to restrict pain medication use is overly wide, as many initial proposed solutions often are, but we will narrow it with more time and experience. 

There is no law, regulation or policy that does not cause friendly fire casualties or undesirable outcomes.   Our criminal justice system, for example, demands a not guilty verdict, even if an individual has committed a crime if a designated proof standard has not been reached.  Society has accepted a balance in the courts and elsewhere.  We reject using a wider judicial net that would capture more criminals but would ensnare too many innocents.  It's an imperfect system by design.

Since no system is perfect, we should not aspire to achieve this standard.  We have to tolerate some level of error and fallout.  Similarly, the medicines that doctors prescribe are deemed by the Food and Drug Administration to be safe and effective, but we all know that they are neither 100% safe nor effective.

Our opioid strategy is a work in progress.  Surely, we all agree on the destination.  But, the path to reach that point will be marked by many pitfalls, slippery slopes and difficult terrain.  

Teaching Empathy in Medicine - Lessons from an IV Drug Abuser

We’ve all heard the excuse or explanation that ‘it’s society’s fault’, to explain someone’s failure.  We hear expressions like this often when an individual has committed a crime or simply failed to succeed.  Personal accountability is diluted as we are told that this person came from an imperfect home, had no role models or ample education.

These arguments are often wielded by those who have been favored with society’s blessings and advantages.

As readers here know, I am not politically liberal and regard myself as an independent who usually votes for Republican candidates.  I did vote for Senator Sherrod Brown, one of the most liberal members of the U.S. Senate, a fact that astonished friends and family, as I had concerns about the character of his opponent that I could not overcome.  I am proud of this vote. 

Were you born next to a ladder?

A 19-year-old female was sent to me to evaluate hepatitis C.  She was unemployed.  She had used intravenous needles years ago and resumed using them a few weeks before she saw me.  Hepatitis C was not the immediate medical priority here. 

I felt that I was facing an individual who inhabited an alternative universe from mine.  While I am speculating, I surmise that she faced choices through her life that I never had to confront.  What narrative, I wondered, could this young woman have had that would lead her to her present destination, where she would be self-injecting poison into her body?   I am not relieving her of personal accountability for the decisions that she has made.  Adverse circumstances do not guarantee failure.  Indeed, we all know phenomenal people who have overcome incredible adversity and long odds to achieve and inspire.  I wish that their methods were contagious.  The woman before me, at least so far, was not one of these individuals.

Perhaps, she came into this world unwanted and unloved.  She may not have had adults in her life to build her self-worth and to help guide her.  Maybe, education was a closed pathway for her.  What caliber peer group was available to take her in to soothe her rejection? 

My point is that it’s always easier to judge someone’s failures from higher ground.   Would many of us have reached higher ground if we weren’t born with a ladder that was set up beside us to ascend? 

I’m all for personal responsibility and accountability.   I’m also making a case for empathy, a virtue that has not always been as strong as it should have been in my own life.  

If our ladder breaks and we crash, how would we like to be treated?

American Cancer Society Wants Colon Cancer Screening at Age 45

Until last week, colon cancer screening for most folks started at age 50.  Why 50?   Why hadn’t the colonoscopy coming of age been set younger to prevent the tragedy of a 45-year-old, or an even younger person, developing colon cancer?   In the past 2 weeks, I had to give a young patient and his wife the sad and serious news that he had colon cancer.  Because of his young age, he never received a screening colon exam, as we routinely do with 50-year-old individuals.  Is it time to make an adjustment?

Our colon cancer screening system is not perfect.  It is not designed to prevent every case.  There have been people in their 20’s who have been diagnosed with this disease, and there is simply no way to capture them in the system.  Experts in disease prevention must carefully analyze disease trends and behavior to find the sweet spot of when to begin screening.  And, money is part of this decision.  Let’s face it.  We don’t have unlimited resources to pay for every worthy medical benefit. 

Determining when to recommend mammography, and how often this test should be done, is a very similar issue.

What Starting Age for Screening is a Bullseye?

Colon cancer prevention experts had believed that age 50 was the proper starting point for screening.  Delaying until age 55 would leave too many people at risk, and starting earlier would save too few folks and wouldn’t be worth the cost or effort.  That is, until now.  The American Cancer Society (ACS) issued new guidelines last week recommending that colon cancer screening start at age 45, a radical change from established dogma.  The reason is that colon cancer in younger people has become more common.   Keep in mind, this recommendation did not emanate from a gastroenterology (GI) organization who might be expected to endorse any system that would benefit GI practitioners like me.   The ACS revised its colon cancer screening guidelines on the merits.  We await responses from other respected medical organizations on this issue.  And ultimately, insurance companies and the government will have to buy in to this proposal.

This bold recommendation, if universally adopted, will save lives.  Maybe yours will be one of them.

Memorial Day 2018

I never served in the military.  My father served for 39 months during World War II, but was never in harm's way.  He was in the navy, stationed in California.   Had President Truman not ended the war in Auguts 1945, I think it is likely that he would have been sent to join in an invasion of Japan.

Because I have not served, and no one in my close circle is in the military, it is difficult for me to grasp the full depth and meaning of Memorial Day - a day that the nation honors and remembers its sons and daughters who have served, been wounded and have fallen.

Arlington National Cemetary

I try to connect with the experience as best as I can.   I watch, I read and I listen.  I recently watched Ken Burn's monumental documentary, The Vietnam War, trying to absorb its lessons.  But, I realize that I am still a spectator who will never comprehend the experience as the actual participants and their loved ones appreciate.

I have been honored to have served many men in The Greatest Generation.  One man fought in the Battle of the Bulge, one was wounded on Iwo Jima and another was in Pearl Harbor on December 7th, 1941.

While we can never fully repay the debt that we owe to our veterans and to those in active service today - nor do they ask for this - we can pause together to remember and honor them all.

Are Clinical Trials Safe? The Risks of 'Medical Research'.

The day before I wrote this, I read about a ‘research’ fiasco where 3 individual were blinded after receiving stem cell injections into their eyes.  This ‘research’ was done in a physician’s office and cost each patient $5,000.   What a tragic outcome.  At least two of these patients discovered that this treatment was available by clicking on ClinicalTrials.gov, a name that suggests government approval, which is not true.  Clearly, the name of this website is deceptive.  Neither the Food and Drug Administration (FDA) or the National Institutes of Health had any endorsement or sponsorship role here.  Moreover, press reporting indicates that these patients had scant medical evaluation prior to and following the medical procedure.

Note to readers:

• Legitimate clinical trials generally do not charge patients for participation.
• Legitimate clinical trials have intensive evaluation to screen patients for eligibility.  Many or most patients may be excluded because of specific requirements of the study.  Adhering to these requirements is what helps to make a medical study valid.
• Legitimate clinical trials have a rigorous informed consent procedure.
• Legitimate clinical trials have aggressive follow-up after the experimental procedure so that results and adverse reactions can be measured and recorded. 
• Legitimate clinical trials aim to publish their results in peer reviewed journals.

Ophthalmologists have commented that injecting both eyes with an experimental treatment on the same day is an obvious deviation from acceptable  research practice.  Think about it.  Wouldn’t you want to inject only one eye at a time for reasons that need not be explained?

The Human Eye - Handle with Care!

 Like every doctor, I prescribe medications and treatments that are not approved by the FDA, a practice which the FDA supports.  Much of my advice is based upon my knowledge and experience, and may not be supported by sound medical evidence.  This is not because I am a quack, but because we don’t always have medical evidence for a patient’s particular medical issue.    Should we tell such a patient to return in a decade or two when the supportive evidence is available, or should we use our medical knowledge and judgment as best we can to address the current issue?

However, if I am prescribing a medicine to you off label, meaning for a purpose not officially approved by the FDA, I won’t call it ‘research’ or refer to it as a ‘clinical trial’.  It’s simply an ordinary day in the practice of medicine.  

Who Should Get the Liver Transplant?

People with liver failure and cirrhosis die every year because there are not enough livers available.  Who should receive the treasured life-saving organ?  There is an organ allocation system in place, which has evolved over time, which ranks patients who need liver transplants.  Without such a system, there would be confusion and chaos.  How can we fairly determine who should receive the next available liver?  What criteria should move a candidate toward the head of the line?  Age?  Medical diagnoses? Insurance coverage? Employment status?  Worth to society?  Criminal record?

An artist's rendering of the liver from the 19th century.

Consider the following 6 hypothetical examples of patients who need a liver transplant to survive.   How would you rank them?  Would those toward the bottom of your list agree with your determination?

• A 50-yr-old unemployed poet is an alcoholic.  He has been sober for 1 year.  His physicians believe he will not survive another year without a transplant.
• A 62-yr-old prisoner has end stage liver disease from hepatitis C, contracted from prior intravenous drug use.  He has been showing serious medical deterioration and his physician is concerned that his demise approaches unless he undergoes a liver transplant.  He will be incarcerated for life.  He is taking college classes pursuing an undergraduate degree.
• A 45-yr-old piano teacher has a malignant liver lesion.   Her physicians have advised a liver transplant. Although the survival rate for a liver cancer transplant is reasonable, it is lower than for sober alcoholics or hepatitis C.   There are no other effective treatments available.  Her prognosis with standard medical treatment is dismal.
• A 40-yr-old has end stage liver disease of unclear cause.  Liver transplant would likely save his life.  He is self-employed and has no medical insurance. 
• A 60-yr-old hedge fund operator needs a new liver to survive.  He is concerned that according to medical criteria, he will not be given a liver soon enough.  In exchange for a liver, he offers to donate $5 million to the medical institution to fund cutting edge research in treating liver disease.  This research has the potential improve the lives of thousands of individuals.
• A 55-yr-old is trying to get a liver transplant for his child.  In exchange for preferential treatment, he will stipulate that several family members will agree to donate various organs upon death.

How should the ranking decision made?  What factors should be weighed?  Ability to pay?  Worth to society, assuming this could be calculated?   Probability of long term survival?

Every one of these 6 individuals has a right to receive a new liver, but some of them will be left aside because others will be judged to have a greater right to a transplant. When any decision is made that creates winners and losers, the system will be challenged and attacked by those who decry what they believe to be an unfair process and outcome.  It is for this reason that transplant policy be made primarily by those who are as free as possible from agonizing conflicts of interest. 

A conflict of interest understandably taints our views.  For example, we may be against paying ransom for kidnapped hostages, until our kid is taken hostage.

Opioid Deaths in Ohio - Hell in the Heartland

We are working hard to bend the curve of the opioid crisis here in Ohio.  The cause of the crisis is complex and so is the remedy.  Statistics examining the last several months have not yet been released, but the trend over the past several years is very troubling.  When I first learned that Ohio was the epicenter of opioidmania, I was quite shocked, as I wrongly thought that this plague would spare the heartland.  In contrast, it seems the heartland is ground zero.  While I have no specific expertise in addiction medicine or sociology, here are my speculations on some of the contributors to the current crisis.

• Aggressive marketing by pharmaceutical companies.
• Deceptive marketing by pharmaceutical companies claiming non-addictive potential of their products.
• Economic decline and hopelessness.
• Increasing expectation by the public of a pain free existence.
• Physicians prescribing opioids, rather than non-addictive alternatives, in response to a new prescribing culture for these agents.
• Physicians writing opioid prescriptions containing more pills than necessary.
• Increasing availability of affordable, illicit opioids.

 Ohio overdose deaths were 3613 in 2016 and 5232 for the 12 months prior to June 2017.

A popular bromide is to accuse the medical profession of spawning the crisis.  While my profession clearly bears responsibility here, I think the causes are multifactorial.  The reason it is so important to have a clear understanding of all the causes is that this is essential to successfully formulate a strategy to combat the epidemic. 

It is a much easier task to prevent addiction than it is to treat it.  While I support treatment efforts, experts have told me that the probability that an opioid addict can conquer the addiction is rather dismal.  We all have heard vignettes of addicts who are revived multiple times by paramedics with naloxone, who immediately afterwards return to their addiction.  If fact, some individuals have raised the question if there should be a limit on the number of times that an individual should be revived.  I am not supporting this effort, but merely reporting on it here.  However, city budgets have limited resources.   How might a city’s residents respond if someone died of a heart attack because the paramedics were treating an overdose victim for the 5^th time?  

This is going to be tough work, but I think it’s a battle we must wage.  Moreover, I truly believe that real progress is possible and is ahead.   If we are all pushing in the same direction, then we can start to bend the curve.