Sunday, May 20, 2018

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.  

Sunday, May 13, 2018

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.

Sunday, May 6, 2018

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 5th 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. 





Add this