Sunday, December 30, 2012

Why Doctors Should Write


Sharpening a quill.

I am a physician who writes and I think that more of my colleagues should do so. Not because, we are such skilled wordsmiths or understand plot and characterization. We don’t. But, we confront the human condition every day. We see pain and struggle and fear and rebirth. We have much to share.

Beyond my own profession, I think everyone should write, because everyone has something important to say and to share.

To paraphrase an old Pete Seeger song, where has all the writing gone? Long time past seen. I long for longhand. I plead for paper. I pine for a pen.

Sadly, there has been steady erosion in the craft of writing, which I attribute to the ’new & improved’ forms of communication that have supplanted the written word. In addition, folks don’t simply regard writing as a worthy pursuit. Writing today means tweeting, emailing, texting and various other keyboard or voice activated techniques. This progress, like many other technological advances, has exacted a cost that may be difficult to measure, but is real and it matters. Today’s communications are either robotic directives, such as ‘board meeting cancelled’, or ‘you’r e fired’, or are coded messages that require cryptographers to decipher, such as TTYL and C U L8R!

Writing is intimate. It’s real and it’s raw. It angers and soothes.

I am so struck when I read letters written by ordinary folks in the 18th and 19th centuries, many without any formal education, who write with such grace and poignancy. Yes, they were somewhat flowery, but they conveyed warmth and feelings that can never be transmitted on Twitter. That they were written in longhand, only adds to their authenticity and intimacy.

Today, on those rare occasions when I receive a signed note in longhand, it is a singular experience. I picture the writer at his desk, pen in hand, composing a personal message just for me. The writer might be delighting in the scene that will follow, when I am holding the envelope and imagining its contents. After I open the letter, I hold it in my hands and absorb its words. Afterwards, I can stash it in a drawer to join with other companions that I have received in the past. Unlike the ethereal iCloud, the desk drawer is a real, live treasure chest that I can see and touch.

Master writers from the past created their opuses in long hand and in ink. How did they do it and get it right? Today, this would be an unfathomable task. Today, students and the rest of us write and research in a very different way, cutting and pasting our way to the final draft. I recall as a high school student learning that Hemingway would tell his wife that when he was staring out the window, he was working.

I love words and respect those who use them well. When I am writing, I often wrestle to find the precise word. Is the right word stubborn or tenacious? Bossy or assertive? Timid or reserved?

While we physicians confront an enormous dose of life experiences every day, every one of us has something worth writing about. I’m sure that on any given day, we could send someone a note of love, a letter of apology, a prayer for healing or a description of an experience that moved us.

Why don’t we do this? IMHO, I think I know why.





Sunday, December 23, 2012

Whistleblower Holiday Cheer 2012!



Jingle Frost
Romney Lost
Obamacare is here
Brought to us by the Dems
With promises and fear.

Fiscal Cliff
Might be teriff!
Sailing through the air
Watching Boehner and the Pres
Pretending that they care.

Susan Rice
Playing Nice
Charging in reverse
Kissing up to GOP
Who now say she is worse.

Taxes Rise
Before your eyes
While the masses cheer
Will Medicare go on the block?
Let’s punt this 'til next year!

Obama plan
Kick the can
And claim that it's progress.
Who's to blame? You know his name.
George Bush has caused this mess!

Wishing You Joy and Peace!

Sunday, December 16, 2012

Should Drug Reps be Mute on Off Label Drug Use?


Am I an apologist for the pharmaceutical companies?  I don’t think so, but others may disagree based on some sympathetic Whistleblower posts that have appeared in this blog.  It is without question that the drug companies have been demonized and portrayed as rapacious gangs of greed who seek profit over all.  Haven’t you come across the pejorative term, Big Pharma?  Linguistical note:  The adjective ‘Big’ means evil. Consider:

Big Oil
Big Government
Big Tobacco

Get the point?


 Big Elephant!

I’m not suggesting that the pharm guys and gals are all Eagle Scouts.  These companies operate to make money, just like car companies, the cosmetic industry, the airlines, banks and financial institutions, hospitals, manufacturers, the hospitality industry and retailers throughout the land. 

Here’s a bold Whistleblower pronouncement.

There is nothing evil about making money.

Of course, I want our drugs to be safe and effective.  We need the Food and Drug Administration (FDA) to provide oversight to protect the public interest.  I acknowledge that the industry needs external review and enforcement powers to keep the industry responsible and accountable.   There’s a reason that professional football games need referees.  Somehow, I don’t think that the honor system on the gridiron would be sufficient.  Players cannot police themselves.

But some of the constraints that drug companies face constitute unnecessary harassment that does not protect the public interest.   Pharmaceutical representatives, or drug reps, are prohibited from discussing ‘off label’ use of their drugs with physicians.  (Off label refers to a medicine being used for a purpose not officially approved by the FDA.) I’ve always felt that this edict was silly and stifled communication between physicians and reps.   Yes, some drug reps have aggressively marketed their products for off label use. GlaxoSmithKline and Johnson & Johnson paid handsomely for committing this offense. 

But, there is a clear difference between misleading promotion and honest communication.  If I question a drug rep about off label indications of a drug, a straightforward response  harms no one.  In fact, it may give me new knowledge that I could use to help a living and breathing patient.  Relax, patients.  I am well aware that pharm reps are sales folks and are not my primary resource for pharmaceutical education.  But good reps have deep knowledge of a very narrow medical issue – their products – and often know stuff that I don’t.   They may, for example, know of side effects of their medicines that are not widely known.

Keep in mind that most of the medicines that we physicians prescribe are off label, which is entirely proper and is acceptable to the FDA.  At present, the only folks in the country who can't discuss off label use of drugs with me are the reps.  

Recently, a federal appeals court set aside the conviction of a drug rep concluding that his marketing a drug for off label use was permissible under the freedom of speech doctrine. This ruling only applies to the region under the jurisdiction of the Second Circuit, but this will not be the last legal word on this issue.   More details appear in the New York Times piece that reported the decision.
 
Where should the line be set here?  I’m not sure, but I think the current FDA boundary is overly restrictive.   We need a dose of leniency and a tincture of common sense from Big FDA.


Sunday, December 9, 2012

USPSTF Pushes Back on Hepatitis C Virus Mass Screening.


I spend a lot of my time reading, thinking and writing about politics and medicine.  I love the debate.  Three of the five Kirsch progeny engaged in serious school debate programs, and I believe that they received years of training at our dinner table.  I certainly learned a lot from them – and still do – and I hope they picked up a few worthy lessons along the way.

Some time ago, an associate admonished me to avoid dialogue concerning religion or politics, two of my staple conversation themes.  This advice seemed misplaced as I’ve never had an argument in my life discussing a controversial issue.  Indeed, I seek out these opportunities. I don't want the other individual to change the subject; I want this person to change my mind.

Controversy erupted recently when Hepatitis C enthusiasts pushed back against the U.S Preventive Services Task Force (USPSTF) draft recommendation regarding testing folks for hepatitis C virus (HCV). More turbulence is sure to follow. The Center for Disease Control and Prevention (CDC) had previously issued their guideline advising that all individuals born during 1945-1965 be tested once for HCV.  That would include the Whistleblower who has no risk factors associated with HCV infection. I have not been tested and have no intention of doing so.


Electron Micrograph of HCV

I’ve already posted a vigorous rant explaining why I feel that patients with HCV are overtreated.  As I indicated there, the Food and Drug Administration has approved two new medicines, boceprevir (Victrelis) and telaprevir (Incivek) which have significantly increased treatment efficacy.  HCV patients who opt for treatment are prescribed one of these two medicines along with two others to complete a three drug HCV cocktail.  These are very serious medicines with potential serious toxicities.

I applaud this medical advance and hope that research in the near term will increase efficacy, reduce toxicity and simplify the treatment. 

HCV experts and many physicians advocate treatment to eliminate the virus so that the hepatitis infection will not progress to cirrhosis and liver cancer.  Liver failure from HCV infection is a major cause of liver transplantation.
   
Indeed, if you were a HCV patient and your doctor advised treatment “to prevent liver failure, cirrhosis or liver cancer”, I suspect you would be inclined to accept the recommendation.  I don't think, however, that many patients are given the fair and balanced context when they are considering how to proceed.  Only an informed patient can provide informed consent. 

Consider the following before pulling the treatment trigger.  
  • The vast majority of HCV patients have no symptoms and have had the disease for decades.
  • Only 10-20% of HCV patients will develop cirrhosis, many of whom will function well.
  • The treatment is toxic and extremely expensive.
  • We have no reliable method to determine which HCV patient is destined for future complications.
  • HCV patients who ‘respond’ to treatment may have lived a normal life without treatment.
Is there a role for treatment in this disease?  Of course, but I suspect that once again, medical practitioners are casting too wide a treatment net ensnaring many folks who should be left alone.

The USPSTF just issued their draft HCV guidelines that were considerably narrower than those of the CDC.  The task force recommends HCV screening only for those who are at high risk of the disease, such as those who used intravenous needles or received blood transfusions prior to 1992.  Unlike the CDC, no mandatory screening of folks born during 1945-1965 is advised.  The task force pointed out the absence of proof that widespread screening for HCV would reduce liver disease and mortality.

When the final guideline emerges, there will be criticism.  Some of it may be based on the medical merits, which is fair game. Other criticism will try to game the system.  There’s a huge and growing HCV testing and treatment industry and gazillions of dollars at stake.  Certain stakeholders will advocate policies that endorse widespread screening for HCV.  Will this be only for medical reasons?  Our track record on this issue isn't encouraging.  Beware of conflicts of interests buried under feigned arguments to protect patients. There are 4 million Americans with HCV.  Treatment with the new 3 drug regimen can cost in excess of $50,000 per patient.   Do the math.  

50,000 x 4,000,000 =

We shouldn't retreat from discussing whether treating HCV makes sense.  After all, it's not religion or politics. 

Sunday, December 2, 2012

Mammograms Overdiagnose Breast Cancer - Let the Games Begin!

Breast news is booming.  Mammography is in the news again. We have legions of breast lobbyists that have agendas that are far beyond the true medical value of mammography.  Even legislators have entered the mammographic arena in a clumsy effort to show their pro-women bona fides.  Politicians should not practice medicine.  It’s absurd that they try to do so when they can’t even perform their own jobs competently.



In 2010, the government overturned its own panel the United States Preventive Services Task Force (USPSTF), in response to an outcry from politicians and mammo-cheerleaders. The USPSTF is not anti-mammogram, and neither am I. I’m pro medical evidence. Mammogram enthusiasts often champion positions that are beyond the science.  Beyond the Kool Aid drinkers, there are billions of dollars at stake here.  Medical evidence is massaged by companies who manufacture conventional and emerging imaging breast techniques and by radiologists who interpret the studies.  If you're a player in the Mammogram Industrial Complex, and a major study threatens your livelihood, predict the reaction.  Here are some sample press releases.
  • The study is irreparably flawed
  • The study is a right wing conspiracy
  • The job killing study will shift more jobs overseas
  • The male study investigators want mammography to fail so they can divert research money to prevent prostate cancer
Let me preempt the argument that I am holier than thou with respect to my implication that radiologists may be tainted by a conflict of interest.
  • Gastroenterologists perform too many colonoscopies
  • Colonoscopy is a clumsy tool for colon cancer prevention
  • Colonoscopy advocates primarily rely on polyp removal as evidence of its worth, which is a surrogate marker of uncertain value.
Hopefully, the above statements will support my credibility.
The truth is that mammography, even in its most optimistic light, isn’t the lifesaver that the public believes.  Indeed, some experts opine that women who undergo mammography do not enjoy a mortality advantage, although they may suffer fewer breast cancer fatalities and complications.  While this is a worthy outcome, it is clearly a limited benefit. 
The November 22,2012 New England Journal of Medicine article strongly suggested that millions of women have been overdiagnosed with breast cancer, meaning identifying cancers that would not have progressed or would have been detected later without posing more danger to these women. 
Advances in breast cancer treatment may exaggerate the benefits of mammographic detection.  In other words, a breast cancer survivor might wrongly credit the mammogram as her savior rather than the treatment.
Overdiagnosis of cancer should be regarded a disease itself.  These women undergo unnecessary surgeries, chemotherapy and radiation, which can have profound and lifelong effects on them and their families. It is also costing us a fortune. It is not a fair and balanced approach to showcase women who have been saved without acknowledging the harm that mammography causes  Shockingly, the American College of Radiology issued a statement calling the study ‘deeply flawed an misleading’.  Any conflict of interest here?
It is easy to deepen our cynicism when those who support or attack a view have a personal interest that coincides with their position. 
The medical and political establishments do not reverse course easily.  We have known for years that prostatespecific antigen (PSA) is deeply flawed and harmful. Look how long it took to disarm its advocates, many of whom were urologists who believed in PSA with religious zeal.  Every one of them honestly believed that this test had saved men’s lives.  I do not dispute this contention.  How many men, however, were gravely harmed by treatment of prostate cancer that would have never threatened them?  Isn’t this worthy of some consideration?
Patients need to know the medical evidence that supports our medical advice.  When there isn’t evidence, or the evidence is conflicting, we physicians need to disclose this, and patients should interrogate us directly on these issues.  I welcome this dialogue in my office.
The public has an exaggerated view of the benefits of mammography. For instance, I suspect that most ordinary folks believe that mammography prevents breast cancer, which is completely false and was never its intent. 
The vexing issue for patients is whom can they trust to offer them candid and unvarnished advice?  I believe in truth. It’s not enough in medicine to believe that something is true because we want it to be or because it serves our own interest. 
Have any women Whistleblower readers been counseled about the hazards of mammography by their physicians?  If not, then was your decision to proceed truly informed?  Aren’t your breasts worth knowing the whole story?

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