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. 

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?

Accutane Users Win Huge Verdict Against Roche. Who's the Winner?

I was engaged in one of my pleasures, sitting in a coffee shop leafing through medical journals. Usually, I am perusing newspapers. I spend many hours each week combing through various newspapers and routinely forward items of interest to folks of interest. No newspapers today. I have a few gastroenterology journals to look through. My professional reading habits have evolved over my career. I am more interested in reading about medical ethics, health care policy and the art of medicine than in studying hard science or clinical research, which used to be my required reading years ago.

I read an essay entitled, Irritable Bowel Syndrome (IBS) Patients’ Willingness to Take Risks with Medications published in the June 2012 issue of the American Journal of Gastroenterology. The article stated that IBS patients would accept a small chance of death if there were an overwhelming likelihood of cure. This caught my attention. Of course, IBS can be a debilitating illness. But, it is not cancer and poses no threat to life. Nevertheless, patients who are desperate for succor, would accept a small risk of a premature journey to the hereafter. While many physician would not be comfortable with these odds, if patients make an informed judgment, then it is their call to make.

Patients need to know the material risks of a medicine or treatment in order to provide informed consent. For example, many successful medical malpractice lawsuits prevail because the plaintiff claims that the physician ‘failed to warn’ of a known complication. The plaintiff alleges that if he been properly warned of a potential rare complication, then he would have rejected the risky and reckless treatment. These cases often suspend disbelief. Do we believe that a patient with a serious medical condition would have declined a treatment if informed about a 1 or 2% chance of a dangerous complication? Give me a break.

In New Jersey, a cauldron for medical malpractice litigation, a jury awarded damages of $18 million to two plaintiffs who developed colitis after taking the drug Accutane. They claim that the company, Roche, failed to warn about this complication. There remain over 7000 cases of alleged Accutane induced colitis that are pending.  Roche has paid out nearly $80 million in verdicts and denies that their medication causes this complication. I wonder how much medical research could have been funded with this incomprehensible amount of cash.

I am a gastroenterologist who has never seen a case of colitis linked to Accutane. I am not certain that this complication truly exists, even though a jury of ordinary folks accepts this, particularly when an ailing person is seeking ‘justice’ from a rich and heartless pharmaceutical company. The first I ever learned of a supposed connection between Accutane and colitis was when I read about a medical malpractice case in a newspaper years ago.

Does this drug truly cause colitis? Who knows? Is the company responsible for not warning about a complication that it doesn’t believe exists? Do we believe that a patient with disfiguring acne (Accutane was prescribed for severe acne, not typical teenage blemishes.) would decline a highly effective medicine because there might be an extremely small risk of developing severe colitis? I would suggest that these patients, like suffering IBS patients, would accept considerable risk in return for considerable relief.

In 2009, Roche took Accutane off the market after enduring tens of millions of dollars in verdicts. Who emerges victorious here? Choose the best answer.

• The public
• The medical profession
• Roche
• Trial Lawyers

Would trial lawyers abandon a case if there was a 1% chance they would lose?

Romney is a Loser - Is This a Fair and Balanced Judgment?

Romney lost.  This update is for those who have just awakened from a deep coma.  I voted for him which will not surprise even the occasional reader of this blog.  While he was an imperfect candidate, I believe that a businessman whose successes have straddled the public and private worlds may have provided a pathway forward out of the abyss.  Sure, I recognize that campaigning is quite different from governing.  Had Romney prevailed then he would have been opposed by an obstructionist Senate that would have stiff-armed him in the way that I expect the House to do to the president.

 

The loser always faces a merciless post mortem where pundits and pontificators point out the series of fatal errors that the candidate committed. 

“He dissed the Latinos.”

“He didn’t reach out to women.”

“He tacked too far to the right in order to gain the nomination.”

“He made a $10,000 bet with Rick ‘Brain-Freeze’ Perry on national TV.”

“He introduced us to the concept of ‘self-deportation’.”

“He was clumsy abroad.”

“He was clumsy here.”

“He was too soft on Bengazi during the debates.”

“He was too hard on the 47%.”

“He returned too late to the center.”

Of course, all of these criticisms are legitimate.   I’ll add my own criticism to the list.  No candidate seeking high office should ever have any member of his family engage in dressage, an activity that was entirely foreign to me and most of the hoi polloi prior to the campaign.  Let the Googling begin.

Where were these conservative carpers during the campaign?  Not only were they mute on criticism, but many of them were enthusiastic cheerleaders.  Now, they are spinning like pin wheels as if they knew all along how the Romneyites were faltering and destined for a stinging loss. 

Had Romney prevailed he would be heralded as a political genius and the conservative naysayers would all be competing to reap credit for a victory that each one would claim to be responsible for. 

This is not fair and balanced.  Of course, had the president lost, we would be witnessing the same process.  Leftists and moderates would emerge screeching their hollow claims of ‘I told you so’. 

Why exactly does this post-election drivel belong on a medical commentary blog?   You mean it isn’t obvious to my erudite readership? There’s an analogy between the recent dissection of the Romney loss and the practice of medicine. Consider this scenario.

• An adverse event occurs in medicine despite the best efforts of the physician.
• The doctor is blamed for the event.
• Various experts emerge who point out in retrospect the physician’s obvious failures that seemed acceptable at the time.

Sometimes, patients get better in spite of our efforts.  When this occurs, we may be unfairly lionized as heavenly healers.  On other occasions, patients suffer despite our best efforts.  When this occurs we may be unfairly blamed for the result.

Should our judgment of a doctor, or anyone, depend upon the outcome or the path that led there?  How do you vote on this question?

Electronic Medical Records Holds Doctors Hostage

Which of the following events is most traumatic for a practicing physician?

• Your staff doesn’t show up because the roads are flooded, but the waiting room is full of patients.
• Medicare notifies you that coding discrepancies will result in an audit of 2 years of Medicare records.
• You receive an offer of employment by a corporate medical institution who will bury your practice if you do not sign.
• Your key expert witness defending you in your upcoming medical malpractice case is incarcerated.
• Your office electronic medical records (EMR) system suffers a cardiac arrest.

Tough choices, I know. Our office lost complete access to EMR for 3 days, and it wasn’t pretty. I don’t grasp the technical (doubletalk) explanation for the temporary EMR coma, but we were reminded of how dependent we are on technology. Our IT gurus were working tirelessly, but their adversary was wily and formidable. Finally, they prevailed, but I wouldn’t regard this as a clean win for us. We were hobbling for 3 days. The fried server has been rebuilt and now has reinforcements to insulate against another crippling assault.

Ink and paper never crash.

Luckily, our brains were still functioning adequately during these 72 hours. We hadn’t yet lost the ability to obtain a medical history without pointing & clicking. Somehow, we managed to obtain a review of systems without trolling and scrolling across our laptop monitors. Ancient physician techniques, such as maintaining eye contact and offering nods of understanding to patients, were effortlessly recalled, like riding a bicycle. I even prepared a few paper prescriptions, once I was able to locate a yellowed and tattered prescription pad. I hope the pharmacies will accept these medical anachronisms.

The tough reality is that during these 3 days we had no records available for the patients we saw. We compensated when we could, with faxes and phone reports, but this is no substitute for a complete medical record. Patients arrived to review test results that we couldn’t access. In some cases, I had faxed biopsy reports available, but not the accompanying endoscopy operative reports that were hiding in the EMR black hole. Patients were understanding of our dilemma, since many had faced their own computer rages. But, many of them did not receive a full measure of medical services from us. I asked some to return to see me for another visit, once the EMR was resuscitated, as I feared I may have overlooked some important issue during the 3 days of Stone Age medicine.

Karl Marx

To paraphrase, the most famous phrase uttered by the individual pictured above, technology is the opium of the people. We love technology. We demand it. We upgrade it. And, we are hooked on it. Like any addiction, when the fix isn’t there for us, withdrawal is painful.

I’m thinking of opening the first chapter of Techno-Addicts Anonymous. Of course, the first step of recovery is the toughest. “My name is Whistleblower and I am a…”

Does Doctor to Doctor Communication Protect Patients?

One of the gripes that patients have about the medical profession is that we physicians don’t communicate sufficiently about our patients. In my view, this criticism is spot on. Patients we see in the office often have several physicians participating in their care. The level of communication among us is variable. While electronic medical records (EMR) has the potential to facilitate communication between physicians’ offices and hospitals, the promise has not yet been realized. The physicians in our community, for example, all have different EMR systems which simply can’t talk to each other. We can access hospital data banks from our office, but this is cumbersome and burns up time. Ideally, there should be a universal system, an Esperanto approach where all of us utilize the same EMR language.

On the day I wrote this post, I participated in a direct conversation with the treating physician at the hospital bedside which vexed me. This scenario would seem to be ideal from the patient’s perspective. At the bedside were the attending physician, the gastroenterologist (the Whistleblower) and the anesthesiologist who were conferring about the next appropriate diagnostic step in a patient who had experienced upper gastrointestinal (UGI) bleeding.

I was asked to evaluate this patient with UGI bleeding and to arrange an expeditious endoscopy to examine the esophagus and stomach region in order to identify a bleeding source. Hours prior to seeing the patient, I scheduled the procedure that I knew would be needed, a short cut that every gastroenterologist will do in order to be efficient. As the patient had other medical conditions, I requested that the sedation be administered by an anesthesiologist, rather than by me, to provide greater safety to the patient.

I arrived and became acquainted with the medical particulars. I agreed with the diagnosis of UGI bleeding and also that an endoscopy was the next logical step in this patient’s care. These observations are not sufficient, however, to proceed with the examination. There are other criteria that must be considered.

• Does the procedure need to be done now?
• Do the risks justify performing the procedure?
• Has the patient provided informed consent for the procedure?

After I arrived on the scene, the anesthesiologist approached me and advised me that the anesthesia risks were extraordinarily high. He was concerned that performing the case could have a disastrous outcome. My reaction to his frank assessment? Thank you! The decision then fell to me to decide on whether to proceed. For me, this was an easy call. The patient did not need an endoscopy at that moment to save his life, the only reason that would justify subjecting him to the prohibitive risks of the procedure. Before discussing this decision with the family, who were awaiting an endoscopy, I summoned the attending hospitalist to relate to him our revised plan. In my view, when an anesthesiologist and the gastroenterologist advise an attending doctor that it would be unsafe to proceed with a planned procedure, the response should be, ‘thank you’! But, it wasn’t. This physician wanted the test and seemed irritated that the set diagnostic plans had been set aside. He wanted a diagnosis, and we declined to proceed after concluding that the risks exceeded the benefits. I was as comfortable with this medical decision as I have been with any other decision I had made in my career. On other cases, when a consultant advises me against a planned course of action for safety reasons, I am so grateful that a patient has been spared from danger.

We got to the right answer here, but had to set aside an unforeseen obstacle to get there. Communication means listening to another point of view and being able to change your mind. As a doctor, when it’s my finger is on the trigger, I call the shots.  I this case, a doctor misfired.

Breast Cancer Screening of Dense Breasts - Dr. Government Prescribes Bad Medicine

This blog is about freedom and personal responsibility.  I have opined that cigarette smokers should not be permitted to transfer total responsibility for the consequences of their choices to the tobacco companies, even if this industry has committed legal and ethical improprieties.  I do not support the politically correct beverage ban in New York City, sure to spread elsewhere, where the government decides the content and dimensions of beverages that the public desires to purchase.  With regard to Obamacare, don’t get me started or I’ll never get to the intended subject of this post.

First, let me refute a point in advance that is sure to be leveled against me by the pro-breast crowd.   I am zealously pro-breast and want all breasts foreign and domestic to remain free of disease. I am against breast cancer and support the goal of striving for early detection of this disease and medical research to prevent it.  Indeed, I am against all cancer and boldly express this controversial view in print for all to see.

Breasts and politics have been intertwined for years.  Many medical advocacy groups admire and envy the huge amount of research money that is garnered for breast cancer research.  Some argue that breast cancer, while worthy, receives a disproportionate share of research dollars at the expense of other crippling and deadly diseases. 

There is no clearer example of the contamination of breast cancer with political interference than Mammogate, when the federal government cowardly rejected the sound and impartial recommendations of its own expert panel for political reasons.

Now, a new scene in the government's Breast Fest has appeared where our elected legislators play doctor.  States are passing laws that require medical facilities to inform patients who have undergone mammograms if they have dense breast tissue and that they should discuss with their physicians if additional testing is necessary. More details are found in the New York Times report on this issue.

I will defer expressing a medical view if women with dense breasts are adequately protected by conventional mammography. If medical professionals, unelected but presumably trained in actual medicine, believe that ultrasound exams or M.R.I. scans are necessary to illuminate dense breast tissue, then brace yourself for an avalanche of unnecessary scans which will generate anxiety, cost a few zillion dollars and identify false positive lesions which are entirely innocent and lead to a breast biopsy bonanza.  This cascade will be fueled also by the medical malpractice system, the raptor present in every mammography suite that is ready to sink talons into its prey.  Am I exaggerating here?  Ask any radiologist why he has stopped reading mammograms.  The guys that still do are scared stiff. These breast images are not sharp iPad images with futuristic resolution.  Instead, they look like grainy collages where it can be agonizing for a doctor to decide if a small smudge is nothing or everything.  Understandably, in today's litigious climate, radiologists join OperationOVERCALL, rather than risk the opportunity to serve as a defendant years later.  

The government are not physicians and should not legislate medical advice.  It’s hard enough for actual doctors to sort through conflicting and controversial medical data and evidence to determine what is best for our patients.  We struggle with this every day.  Will the clumsy axe of government be a helpful player in this effort?   Do we want folks who are beholden to lobbyists and are political animals by definition to force physicians to practice in certain way?

Why stop at breasts?

Pass laws that will require physicians to

• Obtain a CXR if a patient has a cough and a fever
• Tell every patient who has a negative cardiac stress test that the patient can drop dead of a heart attack within a week and that a cardiac catheterization should be considered
• advise patients who are scheduled for surgery to obtain a second opinion in case surgery is silly
• advise patients to pursue the probiotic promise of a panacea.  

Sure, there's dense breast tissue out there.  But, not nearly as dense as the government.  I suppose we should trust them with our lives and our health judging by the sterling performance they demonstrate as legislators.  Congress' approval rating is now soaring at 21%.