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?