Sunday, October 25, 2015

Hear Ye, Hear Ye, Probiotics Cure All!

A probiotic rep came to our office bearing lunch and billions of bacteria.  Who on their staff, I queried, counts the bacteria verifying that each packet has 3 billion disease-busting germs?  I suspect that these quantities are only estimates and that consumers may be unwittingly subjected to either an inadequate dosage or a toxic amount.   Caveat emptor!

I surmise that plaintiff law firms are hiring germ counting experts hoping to establish with clear and convincing evidence that the product's label is false and misleading.  Soon, we can expect to see TV commercials when we will hear an authoritative announcer asks, "If you or someone you love took probiotics and developed fatigue, joint pains, weight loss, weight gain, nightmares, daydreaming, lack of energy, excess energy, loss of a sense of humor, extreme frivolity, lackluster performance reviews at work, basement flooding or any other adverse life outcome, then you may be entitled to compensation.  Call 1=800 GETCASH.  Operators are ready to speak with you in 9 languages.   

After the announcer states his message, scary music plays and we see black and white footage of suffering zombies.

Probiotics, unlike conventional prescription drugs, are not subjected to Food and Drug Administration (FDA) approval.  Hence, the germ guru who brought deep fried food to our office is free to discuss all possible uses of the agent despite the absence of any scientific basis underlying his claims.  Drug reps detailing prescription medicines do not enjoy a similar level of free speech.  In fact, they are securely gagged and are prohibited from discussing off label use of their products, even if we ask them about it.  If these guys and gals stray off message, not only will they be summarily terminated, but their companies may be heavily fined, as many have learned.

Drug Reps Cuffed by the FDA

Does this make sense?  Prescription drug reps, whose products have been rigorously tested and are used off label routinely, can't even whisper or use hand signals to communicate important but unofficial information to doctors.  In contrast, a purveyor of probiotics, whose products are unregulated and unproven, can sing like a canary extolling the benefits of billions of germs that we're told can fight all kinds of illness, foreign and domestic.

I've always felt that the FDA is too strict in restricting the content of conversations between drug reps and doctors.  This is an overreaction from pharmaceutical industry abuses with aggressive marketing of off label use to physicians.  As a result of this hyper response, physicians are deprived of an important information resource from reps whom have a very deep knowledge of a narrow subject.  Who wins here?

Who needs prescription drugs anyway, now that I know that probiotics are the panaceas that can cure all.   

Sunday, October 18, 2015

The Daraprim Debacle - The Smell Test Sniffs Out Price Gouging.

You don’t need to be an ear, nose & throat doctor to be conversant with the ‘smell test’.   We use this technique in everyday life.  This diagnostic test is used to determine if a situation is an egregious deviation from established norms.  The beauty of the smell test is that one need not be encumbered by facts and data.  It relies upon emotion and instinct, which greatly simplifies its use.  Let me illstrate.

Situation When Smell Test Does Not Apply

  • Grading the SAT Examination.  Sniffing and smelling just won’t work here.

Situation When Smell Test Applies
  • A city mayor hires his brother in a no-bid contract as a consultant. 

Are you catching on here?

The Mother of All Smell Testers

I surmise that my erudite and insightful readers would sniff deeply through flared nostrils if they confronted the following situations.
  • “A double dip ice cream cone, which yesterday cost $4.25 is now $57.85.  A severe shortage of sugar cones developed last night.”
  • “The Sunday New York Times is now priced at $82.  Middle East turmoil has caused the price of newsprint to skyrocket!”
  • “Your overnight Fed Ex envelope will cost $325.  We haven’t had a price increase in 4 months and will use this revenue to serve you better.”
  • “Yes, I can reschedule your airline ticket with a keystroke for only $150.”
  • “Call this number and I will send you absolutely free my fool proof system to make millions in real estate without any money or experience!”
  • “One fat-burning pill a day will melt the pounds away without changing your diet or exercising!”

 No explanation, even when delivered by an authoritative  PR pro can make the bad smell go away.

Recently, Turing Pharmaceuticals acquired the drug Daraprim, which is used to combat toxoplasmosis, a potent parasite.   The new company decided that a slight price adjustment was necessary.  So, the price per pill was increased from $13.50 to $750.  No typo here.  Feel free to use your preferred search engine to seek out the company’s explanation for their mega-gouging.  While I always try to remain open to opposing views, can any explanation exist that would justify this increase?

This is an example of corporate excess that will boomerang right back to strike the perpetrator.  Wanton greed and arrogance will surely provoke anger and bring a hammer of reform crashing down.  Ask your doctor.  Physicians understand what happens when a profession refuses to heal itself. 


Sunday, October 11, 2015

Is More Gun Control the Right Prescription?

Guns are in the news again.  Here are some incontrovertible facts.
  • Mass murders committed by young males have become a new phenomenon in American life.
  • Individuals who should not be permitted to own a firearm can legally purchase one.
  • Many other advanced nations have much lower incidences of mass killings.
  • There is no political solution to this issue in sight.
I remain skeptical  that restricting guns will make us safer.  I doubt that further legal restrictions against buying guns would apply to criminals who by definition are law breakers.  I concede that we should consider additional barriers to keeping guns away from those who are mentally unstable.  I challenge any reader here to offer a template on how we might accomplish this.  There are tens of millions of Americans with mental illness or a history of mental disease.  What about creepy people or folks who seem angrier than they should be?  Loners? Assuming we could identify these millions of citizens, how would we use this information in the event that some of them wanted to buy a gun? Tell me how you would do this because I haven't a clue here.

Consider these facts.
  •  The vast majority of mentally ill Americans will never commit violence.
  • Medical ethics and privacy regulations do not permit identifying mentally ill people. 
  • New or existing laws would not have prevented most or all of these mass killings.
  • We have no reliable method to predict a person’s violent potential.
Even if we could eliminate these horrible paroxysms of violence – a worthy and necessary societal objective – we should realize that most of the hundreds of thousands of yearly deaths by gun are not mass murders.

Is this the enemy?

An overall reduction of violence will not be solved by incarceration or gathering up guns.  The solution that continues to evade us will be as much from economic social, and educational policies as from our legal response.  I am not ‘blaming society’ for the actions of criminals.  But, I do believe that the solution will be of societal origin. 

I know many gun owners.  I understand their passion in protecting their constitutional right to own a firearm.  They recoil when gun control advocates pose questions such as, ‘why does one person need so many guns?’  They believe that unfettered gun ownership is their right and it is not for others to limit it.  Many of us use the same argument with regard to free speech.  Ugly speech and provocative art are protected.  Haven't we heard protests against offensive art by those who argue 'why should a museum display this filth'?   

Like everyone, I am angry, vexed and ashamed.  As physicians understand, making the diagnosis is often the easy part.

Sunday, October 4, 2015

Make America and the Medical Profession Great Again

Even those who have but a passing interest in the American political know that Donald Trump is:
  • Very Rich.
  • Leading in every poll.
  • Going to build a wall that Mexico will pay for.
One of these 3 statements will remain true even if Trump’s campaign tanks.  He will still be rich.  I’ve heard some of his flailing critics who are claiming that he isn’t worth $10 billion, but only $5 billion.  Wow, that’s a really potent attack strategy.  I think that if his net worth is a mere $5 billion that he will manage to squeak by.

The Hollywood Walk of Fame

Because he is rich, he is self-funding his campaign.  He points out repeatedly that his adversaries are taking millions from lobbyists and other special interests who will expect something in return.  Of course, these candidates deny this, but we all know the truth here.  Remember, access is power.  If you donate a seven figure sum to support a candidate or a president, do you think it would be difficult to get your phone calls returned?   Do you think that various corporations donate to specific candidates only because these candidates support‘good government’?  They do so because they want something in return.  Many companies take no chances and donate to both Democrats and Republicans.

The New York Times recently reported on a published study that describes the practice of soliciting rich patients for cash to donate to support the physician’s research or the medical institution.  Readers are invited to review the article to become better informed.  Donating to a medical institution is a praiseworthy and ethical act that merits commendation.  If a philanthropist donates to support an institution’s Alzheimer research program or cancer vaccine research, then we should all be grateful.  If a wealthy family decides to make a generous gift because a family member’s life was saved, then everyone wins.

These examples are ethically distinct from a physician directly asking their patients for cash. Some programs try to carve the doctor out of the process while others don’t.  Shockingly, some doctors were offered a cash reward if his rich patient gave the institution a cash reward.

One not be a graduate student in bioethics to recognize how improper this scheme is.  Here are a few crimson flags.  Feel free to add your own.
  • Should physicians should look upon their patients as revenue reservoirs?
  • What preferential medical treatment would a donor expect and receive?
  • Would a patient who declines to donate fear or receive lower quality care?
  • Would physicians recruit rich patients with the hope of soliciting funds?
  • Would a wealthy patient who is seeking care from a select physician be contacted by the development office for a ‘conversation’?
Who is going to make the medical profession great again?


Sunday, September 27, 2015

Heroes Behind the Counter & In Other Places



The Marvelettes in 1963

Patients are cool.   I did a colonoscopy on a hospitalized man who was saddled with the ravages of obesity, diabetes, sleep apnea and respiratory disease.  My partner had performed the initial consultation, and it was my task to bring light into a dark place by performing a colonoscopy.  I engaged in some conversation prior to the procedure, not simply to acquire relevant medical facts, but also to establish some rapport with a man I hadn’t met before, who I was poised to violate.  I learned that he was a navy SEAL decades ago during the Vietnam war, and enjoyed some leisure time in Cambodia then.  He mentioned that he was waterboarded during his training repeatedly and described it as a routine exercise.  Yikes.  When I was his age, I was dissecting a cadaver in medical school.  The most risk I faced was crossing a New York City street.

Fast food workers are cool.  I stop often in the morning at a McDonalds near one of the community hospitals we serve.   This is where I can spread out a few newspapers and sip a carbonated beverage that has zero nutritive value.  I love the older music that is piped in there from the 50s and 60s.  (Don’t tell me you haven’t heard of the Marvelettes,  the Platters or Wayne Fontana and the Mindbenders?)  Denny serves me up when I arrive with courtesy and a smile.  He’s entered the senior phase of life, similar to many other workers at fast food establishments.  Although the food may be fast, Denny isn’t.  He has one speed which is between neutral and first gear.  He’s the kind of guy who just can’t be rushed, despite whatever pressure might be exerted upon him.   We all know folks like this.  Sometimes, I felt myself becoming impatient with this avuncular man who moved at the pace of a loris.  Patience is a lost virtue in a world that demands instantaneous data retrieval and communication.  In my parent’s day, I don’t think they would suffer apoplexy if the person in front of them in the supermarket check-out line was counting out some change.  It took months before I discovered that Denny was an intelligence officer who flew on combat missions during the Vietnam war.  What was I doing then?   Trying out for Little League or participating in some equally perilous activity.  Denny has earned the right to move a little slower than the instagram generation demands.  We can learn a lot from Denny.

Teachers are cool.  I recall a patient who was a science teacher.  I have enormous respect for educators and their profession.   I am partial to science teachers, not only because of my own love of the subject, but also because this country needs to cultivate science and math excellence for our self-preservation.   While I admired him for his career choice, I was in awe of his prior profession.  He was the commander on a nuclear submarine.  While he was circumnavigating the planet, I was writing college application essays. 
I am regularly amazed an awed to learn of the heroic and extraordinary acts of seemingly ordinary individuals.   I am also so impressed with their modesty and understatement.  Over the years, I have learned about their accomplishments because I have asked, not because they have volunteered their heroics, which they often shrug off.

Who’s serving you French fries and a burger?  If you’re not in too much of a rush, you might learn that the man who is giving you change, might have changed the world.  

Sunday, September 20, 2015

Is Your Hospital Crooked?

I read an interesting piece this morning about a medical renegade who turned his back on one of the most powerful health care systems in the world.  It’s not easy to push back against a leviathan.  If I give you an oar, I doubt that you could change the direction of a cruise ship.  But sometimes, a single person can make a wall fall down.  Remember, the brave Chinese man who faced down an approaching tank in Tiananmen Square, which was captured on an iconic video?  On a lesser scale, an orthopedist, formerly employed by The Cleveland Clinic Foundation, decided that his Clinic bosses were preventing him from offering his patient’s the best medical care possible.  He fired them.

"Let's blow this joint!"

The Clinic, in a cost cutting move, restricted orthopedists to using artificial joints from only two device companies.  The surgeon had been using artificial joints from another company for nearly 3 decades, and he reported excellent results.  This orthopedic surgeon had a bone to pick with his bosses, but their edict was as rigid as a steely plaster cast.  There would be no exceptions.

Usually, when stuff like this becomes public, we are greeted by nauseating and sanitized statements from the PR office that generally seek to distract and deflect.  That’s when the PR Prism is so useful.  Consider some examples.

Facts: A sneaker company is discovered to be using child laborers in Southeast Asia for 10 years.
PR Prism: Our company never knowingly hires underage works and always strives to adhere to the highest corporate ethical standards.  We have started a full investigation and promise transparency and accountability.
Translation:  We got caught.

Facts: A presidential candidate deletes tens of thousands of e-mails that were housed on a personal server that was kept in her basement.
PR Prism: I never violated my well known stratospheric standards for probity and integrity.  To the best of my recollection, I never knowingly sent or received any e-mails that any reasonable Secretary of State would have regarded as Confidential, Top Secret or even Semi-Secret in accordance with written Policies and Procedures.  I wish I could share these P & P manuals with you, but of course, they are classified. 
Translation:  Ha! Ha! Ha!

In what I suspect was PR lapse, the statements from The Cleveland Clinic contained some glimmers of actual truth.  I would have expected some doublespeak about how the Clinic is ‘always striving to provide World Class Care…”, but here’s what the Chief of Staff said after acknowledging that their corporate and coercive decisions can give individual practitioners vexing choices

“It doesn’t make everyone happy.  There is a tremendous amount of change going on in health care as we work to drive quality, but do it in a more affordable way.”

I congratulate the Clinic on at least admitting that they trying to save money, and not disguising the cost-cutting under the veil of medical quality.   I support practicing cost-effective medicine, as I have expressed repeatedly in this blog.   However, I suspect there is an important part of this story that was not reported in 9/10/15 Plain Dealer article.

How did these 2 orthopedic device companies get the Cleveland Clinic gig?  Was it based on cost?  Did the Clinic or any of their physicians have financial ties to the companies?  While the Clinic claims that physicians had input into the choices of these two vendors, was the process in truth a preordained corporate decision?  Did artificial joint competitors have a fair shot to bid for the business?  If a competitor sold artificial joints to a Clinic competitor, would this company be shut out? 

This issue goes well beyond artificial joints.  Every hospital in the nation makes deals for artificial joints, heart valves, intravenous catheters, medications, surgical instruments and radiology equipment.  Increasingly, these are as much business decisions as they are medical decisions.  If a product or service can be delivered more cheaply with no loss of quality, than we all support it.  Who do patients trust to make these judgments?  Your doctor or the hospital’s accounting department?

I’m not suggesting that the Clinic, or the hospitals where I practice are crooked.  But, the medical industrial complex has many tense conflicts of interests that are sequestered far beyond the view of the public.  I’m sure there are troves of hospital e-mails that would be fascinating to review, unless the servers have been wiped clean.