Sunday, February 28, 2016

Protecting Human Subjects in Medical Research

There was a tragedy in France recently that did not involve offensive cartoons, radicalized jihadists or terrorists masquerading as refugees.  Innocent French citizens were taken down by a profession whose mission is to heal and comfort.  A medical clinical trial careened off the rails and crashed.  Were these volunteer study patients properly informed?  Are medical study patients here in the U.S. truly making a free choice?

From time to time, friends, patients and relatives ask my advice if they should participate in a medical experiment.  While I am a doctor, I usually say no.  And, once I explain to them the realities of medical research, they usually say no also.

While my colleagues may chastise me for not encouraging my patients to join clinical trials, my primary obligation is to advocate for the patient before me, not for society.  If physicians contemplate changing this ethical construct to consider the greater good when we advise patients, then we need to engage the public in a serious conversation on this issue.

Warning!  Medical Research Zone

When an individual joins a research project, the medical study is not designed to benefit the individual patient.  This point is sorely misunderstood by patients and their families who understandably will pursue any opportunity to help an ailing relative.  I get this.  I wonder, however, how many of them would sign up if they knew that they would be unlikely to personally benefit. 
There are three powerful conspiring forces that may exert undue influence on prospective study patients.
  • Medical research needs a steady diet of new study recruits.  In other words, the beast must be fed.
  • Medical investigators often have biases favoring their research and truly believe that the new drug or treatment has a real chance of helping study patients.  Phrasing such as ‘preliminary results are quite promising’ may be well intentioned, but may be beyond the facts.    
  •  Patients, particularly those who are not responding to conventional treatment, are vulnerable.

Here’s the truth.   Medical research projects and clinical trials are designed to generate new knowledge that will be used to help patients down the road, not those in the study.  Of course, I cannot assert that a study patient won’t realize a favorable result, but this serendipitous outcome is not the study’s planned yield. 

Beware of the packaging.  If your mom or dad has Alzheimer’s disease, of course, you would be susceptible to the following pitch.

Is someone you love struggling against Alzheimer’s disease?  Our Neurological Institute has been fighting hard against Alzheimer’s disease and is now testing a new drug to help conserve memory.  Call for confidential information.  Doesn’t this wording suggest direct benefit toward volunteers?  Are study participants, in fact, facing risks without benefit? 

I strongly support medical research which is our source of future cures and treatments. The medicines and treatments that we use today are the result of years of research done years ago.  We need to generously fund our respected research institutions.  But, we must ensure that the research community adheres to the highest ethical standards, and that any breaches are exposed and remedied.  There’s a reason that the term informed consent contains the word informedUninformed or misinformed consent can’t be tolerated. 

In France, 90 volunteers were in a study testing the safety of a psychiatric medication.  One is dead and others have suffered irreversible brain damage.  While a horrible outcome is not tantamount to guilt, this is a deeply disturbing event that must be investigated.  We will find out soon enough if the French study subjects were given all the information they were entitled to, and if investigators and others behaved properly.  Even if no lapses are discovered, it will underscore that experimental treatment has unknown risks, which may be devastating.  In other words, investigators may be unaware of the full extent of a study’s risks.  Hence, patients aren’t fully aware either.


If you want to join a medical study to serve humanity – and not yourself – then you are free to make this informed choice, and I applaud your decision.   Helping others is a praiseworthy act.  So is telling the truth.

This piece previously published on www.cleveland.com

Sunday, February 21, 2016

Concierge Medicine - Is it Ethical or Elitist?

Massachusetts General Hospital (MGH), perhaps the most prestigious hospital in the United States, has just announced that it is joining the concierge medical universe.  Concierge medicine offers patients Rolls Royce care for an extra fee.  This model has gained popularity across the country and is attracting both patients and physicians.  Patients receive white glove treatment on demand and physicians have more time with each patient as they no longer are pressured to increase patient volume to pay bills.  I’m sure that some of these physicians have increased their incomes, but others may be paid the same, but enjoy seeing 6 patients per day instead of 20. 

I was struck by $6,000 annual feel that MGH was charging concierge patients, the highest I had ever seen before.  The typical fee I had seen was in the $1,500 per year range.  Six grand per year will get Bay Staters personalized care whenever they want.  They will never wait for an appointment.  I imagine that the waiting rooms will be zen gardens, with music, art and aromas that create an aura of wellness.

Concierge Medical Practice Waiting Room

Keep in mind that the concierge medicine fees are in addition to medical insurance payments.

A criticism of concierge medicine is that it is an elitist two-tiered system of medicine for Americans.  This is ridiculous.  We already have a multiple-tiered medical system in place.  Does anyone doubt that wealthy individuals receive a different level of medical care and quality?  Concierge medicine is simply another avenue for them to do so.  Incidentally, this option is not just for the wealthy.  I know working people here in Cleveland who have paid a $1,500 yearly fee because they are frustrated with the medical status quo and are willing to pay more for a higher quality product.  Another working family may decide instead to pay $1,500 for a family vacation.  We all have different priorities.

While I believe that every American is entitled to receive quality medical care, I don’t believe that someone should be prevented from paying more for a higher quality of service.  The same argument applies to college education, automobiles, vacations, homes, and legal advice.  Preventing folks from paying more to get more harms them, but helps no one else.

Full disclosure:  I am neither a practitioner nor a patient of concierge medicine.  Wonder what a concierge gastro practice would look like.  Gold-plated colonoscopes?  Organic hemorrhoid creams?  Sushi laxatives? 

I have also eschewed concierge blogging.  No elitism on this site.  I give it all away for free.

Sunday, February 14, 2016

Emergency On-Call Physician Policy - A Doctor Dissents

I am known by my patients and friends for my calm, imperturbable manner.  Yes, I am equipped with the full range of human emotions, but few folks have ever seen me raise my voice or demonstrate bulging next veins.  I am not suggesting this is a virtue or a character flaw, but is just the way I am wired.

Sure, I get irritated and frustrated with the absurdities of life, as we all do.   For those who cannot relate here, may I suggest calling any airline carrier to discuss changing your ticket reservation.  If that fails,  then have a go at reaching out for tech support when your home internet goes ‘poof’!

Last week, I did become irritated when I was notified one evening about a patient’s abnormal blood test result.  I was on-call for our gastroenterology group, so I would be the designated physician to notify with concerning test results.  Why, then, was I miffed?

Our community hospital uses a ‘new and improved’ system for notifying physicians after hours of significantly abnormal test results.  The hospital loves it.  I hate it.  Here’s how it works.

First, I receive a text message notifying me that a patient has a CRITICAL TEST RESULT.  I am then directed to call a 10 digit phone number, when I will be greeted by a robotic menu system.  After enduring this labyrinth, I will be directed to insert a long series of numbers, a code which will lead to either a non-human voice announcing an abnormal lab value, or to a radiologist’s dictation of a CAT scan report or some other x-ray study.  The hospital is happy as once I complete the process, their system indicates that the physician has heard the message and now bears full responsibility.  They are in the clear.  Here’s some of my objections.
  • The initial text message often arrives when I am driving.   Attempting this process while driving would be suicidal.
  • The messages announcing the abnormalities are not given with any patient contact information or medical details.  While the hospital is happy, I then have the fun and excitement of trying to find the patient’s phone number, not easy to do at 9 pm.  When I can’t reach the individual, it guarantees a night of insomnia for me.
  • Try listening to any radiologist’s dictation.   I’ve done this many times and often cannot ascertain which language is being spoken. 

I called the lab director and begged to be removed from this automated system.  I argued that, while it satisfied the hospital’s documentation police, it was not serving patients or doctors well.  If a test result is CRITICAL, then I want to be called by a living and breathing human being.  The two of us will have what is called a conversation, providing me with sufficient knowledge so that I will be reasonably equipped when I reach out for the patient.  I may want, for example, to hear results of prior tests, so that I will understand the current results in context.  Get the point here?

The lab director couldn’t promise to release me from electronic bondage.  Throughout the medical profession, I witness the duel between documentation and doctoring.  Guess who’s winning.

Sunday, February 7, 2016

Are High-deductible Health Plans Working?

May I whine for a few sentences please?  My staff and I have a high-deductible medical insurance plan.  As the costs of coverage increased each year, we had to find a product that we could afford for our small private practice.  As any small business owner knows, margins are tight, revenue is declining and expenses inexorably rise.  And physicians, unlike other retailers, cannot raise our fees.  Would you want to invest in a company with this business model?  If so, then contact me directly.

High-deductibles health plans are painful for consumers.  The first several thousand dollars are borne by the individual.  While we have an HSA (Health Savings Account), which confers a tax advantage, it is still painful to fork over wads of one's wages to cover medical expenses.  Isn’t that what medical insurance is supposed to do?

Would we expect fire insurance to cover only part of our house if it burned down?

Will fire insurance cover a fire?

But, I recognize that high-deductible health plans are an effective means to combat over-diagnosis and over-treatment, two of the deepest systemic failings in the medical profession.  Indeed, highlighting these two practices has been a leitmotif of this blog.  I have repeated in multiple posts my belief that patients need to have skin in the game if cost-effective medicine is to be achieved.
Just this past week I have seen how this works.

A close acquaintance has been suffering from arm pain and consulted an orthopedist.  A steroid injection was administered and the situation fortunately improved.  The individual contacted the physician’s office for additional advice and an MRI of the arm was advised.  The patient replied that she would research area radiology facilities for pricing as this service would be out-of-pocket as she had a high deductible plan.  Later, on reflection, the individual decided to hold off on the MRI, particularly as she was improving.

There’s a lot we can learn in this vignette.
  • It’s easy for physicians to order tests that cost them nothing.
  • It’s easy for patients to accept tests that cost them nothing.
I’m sure that if my acquaintance had full coverage with no deductible, that she would have dutifully accepted the advice for an MRI.  Why not?  The doctor wants the test and it’s free.  However, if this patient has to shell out a thousand bucks to view the internal workings of an ailing arm that’s making progress, there may be some push back.  My personal belief is that this MRI was not only expensive, but was not medically necessary, a terrible combination that is responsible for so much rot in our health care system.
 
Of course, I realize the dangers of high-deductible plans.  Indeed, many previously uninsured folks who have been ‘rescued’ by Obamacare are now facing this predicament.  Many of them forfeit medical care that they and their families need because they can’t afford it.  For so many families, a $5,000 deductible is like not having medical insurance at all. This has to be fixed, and it won’t be easy. 

Let me share an arcane law of economics.   It’s easier to spend someone else’s money.  Consider this example.  When you are in a fancy restaurant, and someone else is paying, do you order differently?


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