Sunday, August 8, 2010

Health Care Reform: The Worst is Yet to Come

Do you see or do you observe? Most readers have likely given just a glancing glimpse of the photograph to the left, which I took during recent vacation in Costa Rica. Most, including me, would have recognized that the photograph is a tree, and then moved onto the riveting text. While this identification would be correct, it would not be the whole story. Look more carefully, and see if you overlooked a finding on the photo during your cursory review of it.

The health care reform plan, now law, also has many camouflaged elements that were not visible, even to the informed public. In the coming years, as the layers are peeled back, there will be many surprises for the public and for the medical profession, which I hope and pray will remain a profession.

The Patient Protection and Affordable Care Act was signed into law in March 2010. No, it won’t be repealed, despite some shrill populist campaigning to do so from the political right. I also doubt that the judiciary will turn it back, despite efforts to do so in nearly 2 dozen states. Nevertheless, public support of the bill will steadily wane as its provisions and costs become apparent in the coming years. It remains my view that the plan will cost much more than predicted, and will deliver much less than we have been promised. When this inevitable result occurs, the nation will collectively develop acute carpal tunnel syndrome from the wild finger pointing we will all be engaged in.

Here are some highlights of coming attractions.

No permanent SGR reform. Congress is still kicking the can down the road, year after year. Let me use a fancy gastro term to describe this phenomenon – no guts.

A ‘physician compare’ website will provide the public with results from the government’s Physician Quality Reporting Initiative (PQRI) ‘quality’ measurement program, which we practicing physicians deride as a sham that wastes time and money and fails to assess true medical quality. I’d like to think that I practice high quality medicine. Unfortunately for me, none of the things that I hopefully do well can be measured. What is easy to measure, however, doesn’t really matter.

Mandatory deductions in Medicare reimbursements will begin in 2015 to physicians who do not submit acceptable PQRI data to the government. Physicians must participate in this bogus program, or we will be docked. Another fine example of your overtaxed dollars hard at work.

Requires that an imaging service (e.g. CAT scans or MRIs) with physician ownership advise patients that the imaging services can be obtained elsewhere and provide them with a written list of other available imaging centers. This latter provision is bizarre. Would we expect any business to provide the customer or client with a written reference list of competitors? When I stop by Starbucks for some overpriced and bitter coffee, I don’t expect them to hand me a list of other coffee bars down the street. Perhaps, my own gastroenterology (GI) practice should prominently list all other GI practices within 5 miles of our office in our waiting room.

Seniors currently enrolled in Medicare Advantage programs (25% of all Medicare participants) are about to be cut loose when the government cuts payments to these private programs. Of course, benefits to these seniors will be cut accordingly. Many will be forced over to traditional Medicare at higher costs because of high Medigap policy costs.

Allots relative pocket change to examine alternatives to current medical malpractice litigation. In other words, we are going to study the problem. While we’re at it, let’s commission another study to confirm that the earth is a sphere and not a flat plain.

Independent Payment Advisory Board is a 15 member cabal that will wield great power to control Medicare costs. They are prohibited from reducing member benefits, rationing care, increasing premiums or raising taxes. So docs, what is the one remaining pool of cash that these guys have access to? See photo below.

Of course, I could write, “Wait, there’s more!”, but you get the idea. Thirty-two million citizens are to be given medical coverage, half of of these under the strained and sagging Medicaid program, when we don't have sufficient primary care power to meet current needs.  Who will see these patients?  Can physicians afford to incorporate large volumes of Medicaid patients into our practices?

I acknowledge that many supporters of the health care reform legislation truly believe that it will serve the public good, or at least initiate a process that will ultimately deliver true reform.  I don't agree with them.  While there will be fewer uninsured Americans - a most worthy outcome - it is not clear that they will have ready access to quality medical care. Is it worth lowering the quality of our medical care system in order to cover more individuals?  Many would privately agree with this compromise, but would never say so in front of a microphone.
While it is politically palatable to confiscate and redistribute physicians' incomes, imagine the tsunami that will develop when the patients are fleeced and controlled.  The truth is, similar to the taxes paid by the wealthy, that even if all physicians' incomes were appropriated, it would do nothing to address the cost escalation spiral.  Who will tell patients the truth that the era of endless medical care and treatment will be euthanized?  Look what happened when the apolitical USPSTF issued some modifications on mammography guidelines.  Does the public really believe that they will be left whole afterwards?  Once the medical profession, Pharma, insurance companies, et al are dumped into the wood chipper, then the public will be targeted.  Physicians are the low hanging fruit, but be assured that your government will reach the top of the tree.

I feel like we are all stumbling through the rain forest, during a downpour with crackling lightning overhead. We can’t see where we are going, and we can no longer find our way back to where we began the journey. The ground is slippery and we reach for a branch to steady ourselves. Of course, we didn’t see the viper wrapped around the branch, although he found us. The most dangerous predators are those we cannot see, the lurking in the shadows, ready to strike even though our government guide has assured us that it is safe to pass.

Sunday, August 1, 2010

Evidence-based Medicine in Disguise: Beware the Surrogate!

In this post, I will give ordinary folks a ‘peek behind the academic curtain’. I am not an academic physician, but a mere practicing gastroenterologist who spends my days ‘enlightening’ Cleveland colons. Why do some medical studies, which achieve breaking news status, often fall so short of our expectations? Physicians are cynical about these medical milestones, since they are often short-lived. Today’s cure may become tomorrow’s disease.

A common practice and serious flaw in medical research is to rely upon a surrogate marker when studying a disease. Let me explain. If you endure the following few paragraphs of literary driftwood, you will understand press reporting of medical studies on a deeper level.  This could directly affect your medical care and generate some interesting conversations during your next doctor visit.

A surrogate marker is an event or a laboratory value that researchers hope can serve as a reliable substitute for an actual disease. A common example of this is blood cholesterol levels. These levels are surrogates, or substitutes, for heart disease. If a medical study demonstrates that a medication can lower cholesterol level 10%, then we assume that this will also lower the risk of cardiovascular disease. Why doesn’t this same study determine if an anti-cholesterol drug decreases heart attack rates directly? After all, most folks would rather be spared a heart attack than have a silent decrease in their blood cholesterol levels.

Why are Surrogates Used?

It is much easier and cheaper for researchers to measure surrogates than actual disease events. What could be simpler than measuring blood cholesterol levels? In contrast, it would be a very tough slog to show that a cholesterol-lowering drug reduced heart failure or mortality rates. With a surrogate, medical studies can be completed much more rapidly, in contrast to studying actual diseases, which can take a decade or more to complete. By then, the findings may no longer be relevant. Surrogate research is also much less expensive to perform.

Surrogate results have flashy marketing appeal because their findings can be expressed in catchy headlines that extrapolate the actual conclusions. Haven’t we all read headlines like this?

Research shows that new blood test can prevent cancer

Surrogate research is valid if the surrogate truly represents the disease. Often, this assumption is questionable or outright false. Not long ago, cardiologists were going gaga over the CRP (C-reactive protein) blood test as a surrogate marker for cardiac disease. This was great news for the ‘statin’ drug manufacturers who claimed victory when their medications reduced CRP levels, but did this really prevent heart disease? I wonder. Surrogates often take on a life of their own, far removed from the actual disease they represent. Patients shouldn’t care if their ‘surrogates’ are improving; their objective should be to prevent disease, feel better and live longer. Yet, we physicians have often convinced our patients that surrogate improvement means better health. Monitoring cancer blood tests called tumor markers illustrates this point well.

“Great news Mrs. Bedridden. Your cancer blood test improved 10 points!”

“Thank you doctor, but I still can’t walk.”

In my own field, gastroenterologists remove colon polyps with enthusiasm and zeal. Polyps are not diseases. They are surrogates for colon cancer. We hope and believe that when we remove pre-cancerous polyps that we are reducing your risk of colon cancer. Interestingly, there is no double-blind placebo controlled trial (the gold standard of medical research) that establishes that colonoscopy reduces colon cancer. Just because it sounds logical, doesn’t mean that it’s true. There have been medical studies, for example, that have described treatments that reduce arterial plaque, which is a surrogate marker and not a symptomatic disease. Most of us would welcome a treatment that reduces plaque, because we would assume that this would benefit us by preventing heart attacks and strokes. Assumption, however, is not science.

Those of us who have been reading journals for some time are skeptical before we celebrate the medical breakthrough of the day or week. What is sound medical dogma today may fade over time and become junk science. This is particularly true of surrogate studies, which are indirect by definition.

Those who earn their living and their reputations from medical research may have a different view on surrogacy than I do. Indeed, surrogate research is an important research tool, that can open important therapeutic avenues and stimulate additional research. We must be mindful, however, how easy it is to exaggerate their conclusions beyond the data. The public needs understand this issue. Think about this the next time you read a news flash that promises a medical miracle. Chances are that the miracle is a mirage.

Sunday, July 25, 2010

Tort Reform and the Rain Forest: Lawyers' Advice Needed

When this post hits, I will be out of the country in a rain forest thousands of miles from home. I hope the experience won’t be an opportunity to learn about the tropical diseases I memorized in medical school, and promptly forgot after the test. Prior to leaving, I surrendered my arm to hepatitis A and typhoid vaccines. I hope that they deliver. Of course, if I do get struck by typhoid, then this would have to be someone’s fault. In the medical world, when an adverse event occurs, the interrogative response is often, who screwed up? Hmmm. This gives me an idea. If I did get sick abroad, who could I hold responsible for the medical misadventure? Who could I sue?

As is often pointed out on this blog, I know nothing about the law, rules of evidence or even the most rudimentary aspects of American jurisprudence. So, I need some help from lawyerly readers. Below is my list of potential defendants to blame, if I were to get sick in Central America. I’m sure I have overlooked many ripe targets, and I hope that you will comment on my oversights.

Kirsch vs ?

  • The vaccine manufacturer. Obviously they are at fault becauseI did not experience a perfect outcome.
  • The Republic of Costa Rica: The government should have sterilized the country.
  • My Mom: She did not provide me with adequate immunity. (Pssst, Mom, we can split the recovery.)
  • My Wife: The vaccines were administered by her staff. Clearly, they messed up. (Sorry, honey, business is business.)
  • The Salmonella Germ: I haven’t figured out how to initiate this lawsuit, or to collect afterwards, so I really appreciate some pro bono advice from any erudite juris doctors.
  • God: He could have turned the germ into a pillar of salt, as he boldly did to Lot’s wife in Genesis. Wow, a lawsuit against the Omipotent? Now, that would be 'divine justice'!

Of course, my fervent hope is to remain germ free. I certainly would not want to get sick just to have access to someone else’s cash. It doesn’t seem fair to make someone compensate me for an event that was not his fault. Who could defend a system like this?


Sunday, July 18, 2010

CT Scan Risks: Radiation Danger and Overuse Threatens Patients

Many patients erroneously believe that x-rays and CAT scans have no risk. In their minds, they are non-invasive studies that can cause no harm. Since there are no incisions or anesthesia, they regard the experience as having the same risk as taking a family photograph. How wrong they are.  In my mind the danger from non-invasive radiology studies may surpass the risk of hard core medical treatment. True, radiology tests won’t puncture an organ or a blood vessel, as a surgeon or a gastroenterologist can. Imaging studies do not cause direct damage, but they may lead patients onto the medical battlefield. These diagnostic tests are an insidious force that draws patients into a spiral of direct risk and medical overutilization.

Is this post a shot at radiologists? No, it’s a shot at all of us. Remember, radiologists never order CAT scans; the rest of us physicians do. I certainly am distressed with the obsessive manner that my radiology colleagues interpret studies today, identifying innocent, tiny ‘abnormalities' that will then light a fuse for further studies. In many of these cases, the CAT scans were ordered for defensive purposes, and the radiologists' interpretations often keep the defensive medicine train lumbering forward.

On July 1, 2010, the New England Journal of Medicine, the most prestigious medical journal in the world, published 2 commentaries on CAT scans and medical imaging. While readers are free to review the first and second essays in the journal, I will summarize the major points here.

• Nearly 400 patients in the U.S. who underwent brain-perfusion scans are known to have received an overdose of radiation. How many folks have received a 'brain sizzle' that we do not know about?
• Radiation doses from CAT scans are hundreds of times higher than standard x-rays.
• There is persuasive medical evidence that radiation is carcinogenic.
• Physicians like me who order scans have limited knowledge of radiation doses and toxicity.
• Technology exists and can be further developed to reduce radiation exposure to patients.
• There are no evidence-based standards on the proper role for medical imaging tests. It's a free for all.
• CAT scans are overutilized. Amazingly, about 10% of the U.S. population undergoes a CAT scan each year.  So far, I've never undergone one.  How much longer can I hold out?
• Individual patients should have their radiation exposure history tracked.
• Physicians often order CAT scans and other imaging studies believing this will lower their risk of being sued for medical malpractice.  I can vouch for this in my own experience.
• Radiologists, also seeking to lower their legal risk, routinely identify insignificant abnormalities and advise that these ‘lesions’ be evaluated and scanned in the future to verify that they have not changed.
• Effective tort reform is one mechanism to reduce the number of unnecessary imaging tests.
• Scans are routinely ordered when the probability that the disease exists is low. I have addressed the consequences of this approach in a prior post.
• Radiologists serve as technicians, rather than serve as medical consultants to assist clinicians.
• Medical students are not trained to rely upon medical evidence with regard to imaging tests. Bad habits learned in medical school tend to be sustained throughout a career.

CT scanning, and related medical technologies, are towering milestones that have revolutionized the medical profession.  They have eliminated millions of exploratory surgeries and have allowed physicians to make and exclude various critical diagnoses.  We couldn't function without them.  Nevertheless, CT scan overuse is rampant, and there are no forces that are curtailing or guiding its use.  We are spending billions of dollars on scans that are not medically necessary.  I have ordered some of these scans personally, so I acknowledge that my own practice needs remediation.

We describe medical imaging tests as non-invasive, but this is deceptive.  First, there is direct risk of harm from accumulated radiation exposure.  Secondly, and more importantly, there are the indirect consequences.  For many patients, the radiology suite is a danger zone, a trap door that can drop patients into a medical cascade with no way out. 

Sunday, July 11, 2010

Why Total Body Scans are Scams: Maze vs Bayes

Folks across the country are paying hard cash for total body scans, abdominal aortic aneurysm testing, CAT coronary artery scans and carotid artery evaluations to prevent disease or find important lesions early. It’s a seductive argument, and it’s a scam.

Ordinary patients don’t understand about pre-test probability and positive and negative predictive values. Indeed, all physicians were taught to consider Bayesian theory when ordering diagnostic tests. This is very tough concept for patients to grasp. A critical principle of proper diagnostic testing can be summarized in a single sentence.

If an individual is unlikely to have the medical condition under consideration, then a diagnostic test that yields a positive result is likely to be a false reading.

Here is an illustration demonstrating why patients need to understand this issue. While the forthcoming example is hypothetical, I guarantee that every physician has seen very similar patients in their practices. While the patient presented here has a presumed cardiology issue, every medical specialist and primary care physician can land in the same trap. When this occurs, patients suffer.

A 30-year-old non-smoker sees me in the office with chest pain that is readily relieved with antacids. It is very unlikely to be angina, and probably represents simple heartburn. If I arrange for this person to undergo a cardiac stress test, and the result is positive, then it is much more likely that  the test result is wrong than that the individual has true heart disease. This is not simply my opinion, but a conclusion based upon mathematical and statistical principles. However, try explaining this to a patient with a false positive stress test result. Despite the physician’s reassurance that the test result is erroneous, the patient will likely become anxious and remain unconvinced. Such a patient can easily slide, or be pushed, down a medical cascade that may include cardiac catheterization, or even stenting of a coronary artery that was not responsible for the patient’s symptoms, and should have been left alone.

The key is that diagnostic tests need to be ordered when the patient has a reasonable chance of having the condition under consideration. (If the physician is nearly certain of the disease, then the test may not be needed.) This determination is made on the basis of a careful history and physical examination. When stress tests and various scans are ordered casually by physicians, or requested by patients, then this opens a pathway into a medical labyrinth with no easy way out. Would you prefer to agonize over a false positive test result that pushes you toward medical quicksand, or avoid an unnecessary test in the first place?

Of course, there are rare individuals who have benefited from a scan that was ordered for the wrong reasons. These folks understandably are convinced that the scan saved their lives. These anecdotes, however, which make for potent testimonials, should not change established medical diagnostic principles. Every day, folks become millionaires after purchasing winning lottery tickets. Since nearly 100% of lottery tickets become bookmarks or end up in landfills, we know that this is a poor strategy to accumulate wealth. Should every person undergo a CAT scan of the head every year because it is theoretically possible that a few might benefit by accident? Dumb luck should not be our diagnostic touchstone.

Total body scans, and all of their cousins, are examples of medicine at its worst. It is a commercial enterprise that bypasses sound medical principles and judgment. These entrepreneurs proffer a promise that they know they cannot fulfill. It’s a scam clad in a white coat. For the majority of their unsuspecting customers, a positive result will be wrong and a negative result will guarantee nothing.  I realize that an ordinary patient will celebrate when his total body scan is negative, but this is not how medicine works.  You can have a normal EKG performed weekly, but this will not prevent a heart attack or exclude significant coronary artery disease. 

Still thinking about that cardiac scan being advertised in the newspaper or on television? Do yourself a favor. Buy some snake oil instead. The result will be the same, but you won’t waste nearly as much money and you won’t end up with a stent.

Many patients who have endured a ride on the medical cascade may feel that they were rescued from certain disaster.  I'd rather rescue folks from the cascade.

Sunday, July 4, 2010

Should Physicians Give Up and Surrender?

Photo Credit

More and more, I read about physicians who are ready to give it up. I hear similar views in the physicians lounge and in hospital hallways. These conversations are a modern phenomenon; they did not occur when I entered the profession 20 years ago.

They have germinated as a result of rising forces that have demoralized many practitioners. Some of them include:

• Loss of autonomy
• Loss of income
• Loss of stature and prestige
• Required ‘Quality’ initiatives
• Health care ‘reform’
• Infighting within the medical profession
• Medical liability system
• Insurance company hurdles to get paid
• General gerbil wheel existance

Luckily for me, I am still happy on the job. Of course, I am not immune to the above realities, and would readily accept a vaccine to protect against them, if one existed. I try to focus on the core purpose of being a physician, and work to sequester the noise and static, at least while a patient is seated before me. Since I am a member of the human species, I do not always succeed. Sometimes, stuff creeps out of a compartment at the wrong time, and I try to stuff it back in its place. It’s a struggle, but I usually prevail. So, with regard to being a practicing physician, I am not ready to give up.  I keep my 'white flag' in the closet.

There is a part of the profession, however, that I have given up with zeal and enthusiasm. For me the decision was easy, but for some colleagues it is agonizing. A few years ago, I gave up performing a procedure that is essential for many gastroenterologists. It is called ERCP, which stands for a term that is so long, that I wonder if its practitioners thought they would be ‘paid by the letter’. To save you googlers a key stroke, here’s the term in full.

Endoscopic Retrograde CholangioPancreatography!

This is a fancy endoscopic event when the gastroenterologist passes one of our flexible black serpents down your throat and snakes it around corners to reach the small intestine. Then, tiny tubes can be inserted through the scope into the liver and pancreas to accomplish tasks that previously required surgery. This invention is a towering milestone in the practice of gastroenterology.

How important is this skill in my trade? Peruse the ads at the back of any medical journal under the gastroenterology section and you will read phrases, ERCP required or ERCP preferred.

Why would I give up performing a test that distinguished me in my specialty and made me a more marketable gastroenterologist? Would we expect a professional basketball player to eliminate 3 point shots from his game? Would we expect a concert pianist to declare a moratorium on playing any piece in the key of A flat? Would we expect a congressman to vote on legislation that he hasn’t read? (Yes, you may snicker now.)

It seems odd to voluntarily surrender skills that allows one to occupy a higher orbit in his profession; yet this is exactly what I have done. I gave up ERCP because I simply wasn’t good enough at it. I never killed anyone, and my complication rate was within the expected range for this procedure. It certainly was exhilirating when I was successful, and quite demoralizing when I couldn't get the job done.  More and more, I realized that the ERCP field was advancing, but I wasn’t. My skills were acceptable, but stagnant. Why didn’t I simply incorporate the evolving technology and gadgetry into my practice?  This response is a blog post in itself, but the summary statement is that it is extremely difficult for a practicing community gastroenterologist to stay current with evolving technical procedures.

So, I gave it up, not the professsion, but an important aspect of my practice. It was liberating as I now knew that any of my patients who needed ERCP skills would be referred to someone who did it much better than I could. The quality of a physician – or any occupation – is determined by the weakest element of his practice. I hope that pruning my practice has made it sturdier.

These are vexing issues. When does someone give up an essential element of his occupation? Sometimes, the answer is obvious. We don’t want cardiac surgeons with flapping tremors to perform delicate heart surgery. We don’t want airline pilots who suffer from sudden blackouts to be at the controls. However, sometimes the deficits are more subtle, and it is not clear that the practitioner is impaired to the extent that a professional change is required. Where is the boundary line and who should set it?

Quality measurers from the government, insurance companies and professional medical societies will soon be unleashed on a mission that they can't succeed at. They will fan out across the countryside claiming they can measure the unmeasurable. Those of us who understand the guts of medical care realize that what really counts, in medicine can’t be counted. For example, these qualitycrats might have deemed my ERCP skills to be acceptable, using their check-off boxes and quality rubrics. Indeed, I was granted privileges to perform this procedure in my local hospitals every 2 years through the perfunctory recredentialing process. The reasons that impelled me to set the ERCP scope aside are real and legitimate.  But,  they can’t be weighed and measured.

I hope that the quality buzzards who will suffocate the medical profession give up before we physicians do. I can loan them my white flag.