Sunday, February 8, 2015

FDA and Herbal Medicine - Caveat Emptor!

Many of my patients are taking herbal supplements, or so they think.  This herbal and health supplements industry likely is envied by traditional pharmaceutical companies.  The latter has to spend zillions of dollars proving safety and efficacy to the Food and Drug Administration (FDA).  Many of these drugs are cast aside during the approval process or afterwards when serious side effects become known or a new medicine is proved safer and superior.  While it’s not quite a crapshoot, there is a strong element of chance at play here.

Roll the Dice with the FDA?

Herbs and the supplements that are saturating our airwaves escape FDA scrutiny.  They will only draw governmental fire if they are deemed to be dangerous.  They are required to use certain language in their promotional materials that differs from traditional FDA approved prescription medicines.  Take a look at this example:

Fosamax:  The FDA has approved this for the treatment and prevention of osteoporosis
Glucosamine chondroitin:  Promotes bone health

Somehow the vague but promising phrase, ‘promotes bone health’ is supposed to insulate the company from a claim that it is approved to treat an actual disease.  However, for most of us, promoting bone health sounds like it’s designed to prevent osteoporosis, which is exactly the intent of the company’s marketing folks.  The language may be legally distinct from the Fosomax verbiage, but it sure sounds the same to me.

The FDA has a very light regulatory hand over dietary supplements making sure that there are no overtly misleading claims and that the product contains what the label states it is.  There is no FDA approval of efficacy as is required for prescription pharmaceuticals.

With a market worth billions of dollars, would you prefer to invest in a pharmaceutical company that might need 7 years to bring a drug to market or in a supplement manufacturer that only needs to cross over a few speed bumps before marketing potions that combat fatigue, joint pain, depression and memory lapses?

It amazes me that the public swallows millions of these pills in the absence of medical evidence of efficacy.   Who says that Americans are not a people of faith?

Recently, a New York State investigation discovered that 4 out of 5 herbal products tested contained none of the herbs listed.  The investigation examined herbal products at some little known ‘mom & pop’ pill shops including Walmart, GNC, Target and Walgreens.

If a company is peddling a placebo, can't it at least accurately label the herb?  If I'm buying a jar of snake oil to ease my rheumatism, or should I say to promote good joint health, then I expect that the useless elixir won't be lizard oil, olive oil or motor oil.  

Sunday, February 1, 2015

Medicine is an Art and Science

Medicine is an art, not a science.  We’ve all heard that maxim before, but what does it actually mean for living, breathing patients?

Physicians rely upon knowledge and experience when we advise patients.   We try to stay current on relevant medical studies to guide us, knowing that the latest medical ‘breakthrough’ may be debunked in a few years.  Seasoned physicians resist the temptation to abruptly change their medical advice based on a single study, even if published in a prestigious journal.

Knowledge and experience are important, but judgment trumps them both, in my view.   The best clinicians are those who consistently exercise excellent medical judgment.

A knowledgeable physician may be able to recite a dozen explanations for your high calcium level.
An experienced doctor can expertly perform a colonoscopy having mastered the technique.
A physician with a high level of medical judgment knows that surgery is wrong for a particular patient, even though medical textbooks and journals recommend an operation. 

Judgement Outweighs Knowledge

Keep in mind that medical judgments are not right or wrong.  Physicians on the same case may have differing judgments and recommendations.  This is a typical scenario in the medical universe which can be vexing to patients and their family.

Consider a few typical patient vignettes which call for medical judgment.

A cardiologist recommends Coumadin , a blood thinner, to start today to treat a patient’s heart condition.  The gastroenterologist wants to delay this for a few weeks as the patient has a duodenal ulcer that could start bleeding once the blood thinner begins.   When should the Coumadin be started?

A man undergoes a CAT scan of the chest which shows a 1 cm nodule in the lung.  The nodule is slightly larger than it was 6 months ago.  The patient is a smoker.   The location of the nodule is at high risk for a serious complication if a biopsy is done.    Should the biopsy be done to determine if a cancer is present?  Considering the risk of the biopsy, should the lesion be watched with a repeat CAT scan done in 3 months to see if it is enlarging or remaining stable? 

A patient is seen by a surgeon after a severe attack of abdominal pain, which resolved.  The patient was immobilized during the pain and was seen in an emergency room where he was found to have a gallbladder full of gallstones.   The surgeon is not certain that the gallstones were responsible for the pain.  The patient is very frightened that if nothing is done, that the pain might return.  Should the surgeon remove the gallbladder, which might have nothing to do with the pain, or advise watchful waiting?

Medicine is art and science.  If I’m sick, I’ll skip the scientist.  Give me the artist.

Sunday, January 25, 2015

Money Back Guarantee on Medical Care?

How many times each week do we hear the phrase, 'if you're not completely satisfied, we'll refund the purchase price - no questions asked."

This is more often a marketing ploy than a true money-back guarantee.  I have a sense that trying to obtain a promised refund on an item that dissatisfied us is about as easy and carefree as changing an airline ticket reservation or reaching a live human when our home internet service is down.   So, when the weight loss pills don't really melt the pounds off, don't be shocked if the check isn't in the mail when you mail back the placebo pills to a post office box several states away.  And, of course, you won't recover the shipping and handling costs.

Send Stuff to P.O Box in Southeast Asia

This is my opportunity to ask for help from my erudite readership.  What exactly is shipping and handling?  Doesn't postage already cover the 'shipping'?  $8.95 seems pricey for a 'handling' charge for anti-wrinkle cream or a set of steak knives endorsed by make-believe chefs.  I don't really want strangers handling my stuff anyway.  Are they wearing gloves, I hope?

I hear a commercial often for a zinc product that promises a full refund if the product does not shorten the course of the common cold.  I do have some medical training, as readers know.  Readers who are smart enough to understand'shipping and handling' are asked now to explain how an individual can assert that the zinc product was not effective.

The Complaint

"Please give me a full refund.  My cold lasted 6 days. Usually, I feel better by the 5th day.  Your zinc stinks."

The Response

"Thank you so much for your input.  All of us at Zinc Jinx, Inc.welcome customer feedback.  Please send urine samples for days 4,5 and 6 packed in dry ice at your own expense so we can verify that you were taking the product as directed.  Include all packaging including the shrink wrap around the bottle that you should have retained had you consulted our customer service web site prior to opening.  Expect a response in 6 weeks.  Even if your urine drug content is deemed to be sufficient, our on site cold and flu experts may conclude after impartial study that your cold would have lasted 9 days without our product."

I'm not offering an opinion on zinc's effectiveness in fighting the common cold.  I'm suggesting that it is not possible for a zinc swallower to really know if zinc expedited his recovery.  Belief is not evidence.  If we recover on day 6, perhaps, zinc was an innocent bystander receiving credit for a favorable outcome that it did not contribute to.

Sometimes, we physicians are lucky in the same way.  Our patients get better, as they usually do, and we get the credit. As we know, the converse is sometimes true.  We get blamed when we don't deserve it.

Should doctors offer a money back guarantee if our patients are not fully satisfied?  The zinc scenario illustrates how difficult it can be in medicine to assign credit or the blame for the outcome.  The only secure guarantee in medicine is that there are no guarantees. 

If any reader is not fully satisfied with this post, the full purchase price will be promptly refunded - no questions asked.  

Sunday, January 18, 2015

The Doctor-Patient Relationship, Is There an App for That?

I just deposited a check into my bank account by photographing the check with my iPhone and zapping it through cyberspace.  I realize this is ho hum to the under 35 crowd.  Soon, there won’t be any paper checks as the entire transaction will occur electronically.  As a member of the over 35 crowd (plus 20 years), I am wowed by this process.  I remember being astonished when my kids told me how they performed this same process months ago.   It’s the same amazement I experience when I first read about a new piece of technology called a ‘fax machine’.

You mean you slide a document into a machine and an exact copy emerges elsewhere?

In my younger days, depositing a check into a bank account meant waiting in line with my bank book in hand waiting for a living, breathing human to count and record my allowance and snow shoveling earnings.   The bank that my kids use has no physical offices.  It is entirely in the Twilight Zone.

Medicine will not be left behind here.  The manner in which medical care will be administered will be beyond what we can imagine.  We are seeing glimpses of it already, but our vision of its trajectory is limited.  There will be huge advances, but as with all technology, there will be a cost.  The traditional doctor-patient relationship will fade out as this will not be the bedrock of medical care.  There will be nostalgia for it from those who experienced it, much as I have warm memories of bank books, rotary phones, ice cream sodas and playing basketball after school in the school yard.

I’m sure there is technomedicine going on today that I’m not aware of and would be amazed by.  Smart phones will become medical diagnostic tools.

Easy Stuff
  • Tell Siri your history and send a photo of your rash to DERM APP and prescription will arrive at your door in 1 hour.
  • Place phone on your chest and cardiopulmonary data will be forwarded to your cardiologist who will transmit medication adjustments to you electronically.
  • Shine beam of light through a urine specimen which will confirm if urinary tract infection present.
Hard Stuff
  • Coronary bypass surgery performed robotically by a surgeon in New York City on a patient in Abu Dhabi.
  • Artificial organs created in 3-D printers.
  • Miniature cameras journeying through the digestive tract, circulatory system and major organs delivering customized treatment for various diseases.
  • Smart phone analysis of saliva sample which will screen for risk factors for 20 common chronic diseases that will have effective preventive strategies.
  • Satellite delivery of yet to be discovered form of radiation to the developing world which will decimate food borne illness.
  • Patient will place his palm on a glass and an electronic signal will be transmitted to internal organs whose function needs adjustment to treat disease or preserve health.
I worry about the collision of technology against the doctor-patient relationship, which is an ongoing conflict. For example, most patients and physicians do not feel that electronic medical records have nurtured the doctor-patient relationship.  I think it's been a wedge separating physicians from patients. Generally, the tidal wave of technology forges ahead with no true regard or attention to the ethical costs incurred.    Doing stuff just because we can doesn’t make it right.  Smart phones won't be smart enough.. Will there be an app for empathy, compassion, facial expression and listenng?  Perhaps, AppMD will be tomorrow's health care provider and physicians will join the ranks of typewriter repairmen and encyclopedia salesmen..  

Sunday, January 11, 2015

Rolling Stone Magazine Rolls the Truth

 Recently, I was with a group of good friends whom I have known for 20 years.  They are a spirited group of unabashed liberals.  I doubt any of them have ever voted for a Republican, or ever would.  Of course, we have a secret ballot in this country so we never know for sure.  Publicly, at least, they profess unwavering fealty to the Democratic Party.

I regard myself as a political independent, although I tend to vote Republican.  However, when I am amid this group of left-leaners, they look to me for the ‘far right’ view on the issues of the day. 

Yes, we have different views on the proper role of government and the judiciary, but I don’t look to Ted Cruz or Sarah Palin for political inspiration.

During our conversation, the recent Rolling Stone journalistic debacle that detailed an alleged rape at University of Virginia came up.  Immediately, the prevailing liberal talking point was offered up to the group, expecting acclamation.  

“This Rolling Stone retraction is terrible.   It is a huge setback for women who are victims of sexual assault on college campuses.”

Lots of heads were nodding in agreement, except for mine.

The issue for me is one of journalistic failure, not the overhanging issue of sexual assault on college campuses.  If an account by an alleged rape victim has become problematic and inconsistent, then we should acknowledge this, as Rolling Stone was forced to do, and not automatically rehabilitate the victim to serve a larger cause.   If the press fails its readers and its profession, then that is the issue.   Our focus should be on what went wrong, not how a misdeed might negatively influence a larger agenda.  

Rolling Stone Needs Honest Weights

I’m a physician.   If one of my colleagues is convicted of Medicare fraud, should my initial response be, “Oh, this will be very bad for doctors”?   Shouldn’t I clearly condemn the criminal act without any qualifications?   Apply this example to your own profession. 
When we try too hard to downplay an individual’s action that we think might harm our cause, it detracts from our credibility.   In my view, an organization or an individual that speaks and seeks the truth will only strengthen the currency of its voice for its own cause. 

I understand that sexual assault is a serious issue that demands our full attention and response.  Let me state boldly; I am against sexual assault.  But those who advocate for this important cause need to acknowledge the injustice of a false allegation, such as occurred with the Duke lacrosse case in 2006, a very public example of how lives can be unfairly ruined.  A false or questionable allegation should be identified as such, not lamented as a setback for another agenda.  Many commentators on the Rolling Stone retraction have expressed regret, but not at the possibility of a false charge or reckless reporting.  They are sorry that their cause may have been negatively impacted.

We don’t know for sure whether ‘Jackie’, the protagonist in the Rolling Stone article was truly a victim.  I am not denying the possibility that she was, but I am expressing uncertainty.  We do know that important details of her narrative have not been corroborated.  We also know that inexplicably Rolling Stone acquiesced to Jackie’s request to refrain from interviewing the alleged perpetrators, a professional lapse that made the Rolling Stone piece one of advocacy, not journalism. 

Rolling Stone has requested that the Columbia Journalism School perform a post mortem on the story, which I trust will be an independent and objective review of what appears to be journalistic malpractice.  

Should our reaction to the Rolling Stone’s lapse be that “this will be bad for the journalism profession?”  Or, would a better reaction be that “this will be bad for Rolling Stone?”  

Sunday, January 4, 2015

Ready for the Silent Treatment?

When moved to do so, I wander off the medical commentary pedestal to share thoughts with readers.  This is one of those occasions.   I had a singular experience last weekend that impacted me.

Most of us can agree that there is a paucity of silence in our world.  There is noise and static everywhere filling our time and space with cacophony.  Television news shows have become performances where we watch panels of pundits who appear as clucking hens.  Try to find a coffee shop that isn’t blaring music.  Even sports games on television have every nanosecond filled with barkings from commentators.  Can’t we just enjoy the play?

Last Sunday, I went to a Quaker Meeting House for the first time, accompanied by my daughter Ariella, representing our family.  There was no speaker, ushers, music or program of events.  The room was set up with chairs in each half that faced each other.  Folks took their seats and remained quiet.  At first, I was disquieted by the quiet, impatient for some action to commence, as I would be at a theater, sports arena or musical performance.  Not here.  Several minutes passed and not a syllable was uttered.   Were we all just wasting our time?   On the contrary, I was being offered a rare gift – the opportunity to contemplate in silence.   

I enjoy spending time alone, and I am known to duck out to various undisclosed hideaways where I read and write.  I have not made silent meditation, however, a part of my life.  The Quakers are onto something here.  For them, silence is not the absence of activity, but an opportunity for thought and reflection.   Silence is the event, the music in between the notes.

We were assembled together to recall the life of a remarkable human being, Betty Lake.  Betty had been part of our lives for over 20 years.  We took her on as nanny to what became a house of entropy with 2 working parents, 5 children, a dog or two and an occasional boarder.  We remained actively connected to her for the rest of her life.   She exuded warmth, generosity, good cheer and love with infectious enthusiasm.   She created a Sea of Tranquility in our Cauldron of Chaos.   She loved us all and we returned that love to her in full measure. 

A few years ago, she gifted me a small rocking chair that she had sat in as young girl in Cincinnati.   I treasure it.  I have moved twice since I received it and still display it where I see it every day.

At the Quaker Meeting, after a silent overture, folks stood and offered reflections when they were moved to do so.  By the end, nearly everyone had shared a memory or a vignette about Betty, each contributing a few stitches to the tapestry of her life.  When the meeting ended, we all felt good that we had collectively captured her essence and had honored a woman of such great worth.   Photos of her were scattered on a table and guests were invited to take one home. 

Grab a few minutes of silence today.   Turn the volume down and cherish a transient oasis of calmness and peace.

Thanks, Betty, for all you have given us.   You gave without ever expecting anything back, a lesson that I try to use to become better than I am.