Monday, August 31, 2009

The New Fortune Tellers

I can predict the future!  I can tell you your past!  So read the ads.  No, this is not a new Dan Brown novel or a late night infomercial.  It is the promise of those companies that advertise genetic testing for the masses. 

Personal Genetic Testing bypassing the Doctor

Direct to Consumer (or DTC as it is referred to in the medical journals) advertising of medical and quasi medical genetic tests is now widespread and becoming popular.  A person who so desires can send a cheek swab to a laboratory to have their genetic profile analyzed for a whole host of reasons.  What disease are you at risk for?  Who were your ancestors?  What can you do to forestall disease?  This is becoming so popular that the National Institute of Health in conjunction with the Center for Disease Control convened a workshop to discuss the use of personal genomic services and then published in the August issue of Genetics in Medicine a series of commentaries based on the workshop

Validity and Usefulness of the Tests

There are real questions about this testing.  As the first article in the journal states, “Some scientist have voiced concerns regarding the scientific foundation for the clinical validity(CV) and the clinical utility (CU) of PG (personal genomic) tests and the potential impact on our health care system.”  The fact is that for some tests, such as the genetic tests for breast cancer risk, we know that they have a place in the prevention and treatment of disease however for the great majority of these tests, we just do not yet know whether the association of the specific gene or genes with the disease is truly causative and therefore valid and even if valid, if knowing is going to assist in prevention or treatment. 

The Potential Culture War

In one of the commentaries, James Evans and Robert Green discuss the animosity between the scientific community and the DTC companies now selling the services.  They make a distinction between the companies’ science and quality of testing and the messages they then deliver.  “We may disagree with their choice, interpretations or presentations but they have already been transparent enough about their methods that they cannot be considered fraudulent.”  The better companies in the DTC business uphold scientific rigor in testing however they tend to minimize any possibility that medical information used inappropriately or prematurely can lead to real harm, either directly or by leading to medical interventions which carry risk. 

A Trend to Personal Knowledge and Responsibility

I tend to welcome any trend that puts people in charge of their own health decisions however I do worry about testing that is “hyped” and sold rather than arrived at with reason and thought. Personal genomic testing will change medicine and I only hope it will change it in such a way as to improve care while also putting the person at the center of all health care decision making.

Saturday, August 29, 2009

Finding the Care In Health Care

In the midst of the debates over health reform, it is sometimes hard to remember that medicine is practiced on a very individual basis between one patient and one health professional (doctor, nurse, pharmacist) interacting in a very human manner. The Journal of the American Medical Association does publish a column called "A Piece of My Mind" and many of these pieces are by physicians who remember that imperative to care for the patient and not just diagnose and treat the disease.

"The Other Person"

This week, Dr. Paul Rousseau reveals himself, in writing "The Other Person" to be the caring physician we all wish we could have. In that "Piece of My Mind" article from this week's JAMA, he describes his meeting with a family to discuss the way to support the matriarch of the family, now 83 and infirm following a stroke, through the end of life. Read this and you find a discussion much more about life than about death. Much more about triumph of the person rather than pain control and advance directives. You read about a physician caring for a family and for the patient by understanding their lives, not only their deaths and not only their diseases.

Medicine, Productivity and Lowered Costs

When I read this piece, one thought jumped out at me. This session with the family is very unproductive. It probabaly took too long as talking with someone and just letting them talk about their past, takes a long time. A doctor with fifteen minutes per patient would be deemed an unproductive one by most business and management measures delving into items as irrelevant as the husband's background developing the GPS system for the military and the wive's background as a homemaker and librarian. Well at least under the advanced care planning reimbursement in the HR3200 bill the physician would be paid for that. Well maybe.

Advanced Care Planning Requirements

If we review the 1,493 words in that section of the proposed HR3200, we see specific requirements that must be fulfilled to be paid. Did Dr. Rousseau be sure and fulfill the requirement of providing "The provision by the practitioner of a list of national and State-specific resources to assist consumers and their families with advance care planning, including the national toll-free hotline, the advance care planning clearinghouses, and State legal service organizations (including those funded through the Older Americans Act of 1965)"? I did not notice it in the article but he may have. Would, under a new law, Dr. Rousseau be required to have someone sign a form certifying that all had been done (that was mandated under law) in the counseling session to allow him to be reimbursed for that service?

Caring as a Goal

I don't know how to fulfill the goal of allowing all to have caring physicians in their hours of need but I do believe that it takes more than legislation. In the words of Dr. Rousseau, "It seems that we physicians have strayed from the biopsychosocial model of patient care as well as the humane and personal touch that is so essential to healing and instead have chosen to hide in clinical foxholes where CT scans, laboratory data, and mundane and tangential information is discussed, far far from the bedside, and far far from the essence of the patient. " As we debate how to reform health care, lets think about how to reinforce the ability to find and treat the essence of the patient and not just the disease that they have.

Thursday, August 27, 2009

That CT Scan Is Harmless so I Might as Well Have It?

That statement that introduces this post is one I have often heard from patients and even doctors to justify doing a test that is likely to yield very little useful information. An article in this week's New England Journal of Medicine actually spells out the real risk of diagnositc imaging exams.

The Cumulative Effect of Radiation

Radiation effects on the body are cumulative. That is why we require health professionals who deal with this modality regularly to monitor their radiation exposure. More than 100 mSv in a five year period, or more than 50 mSv in a single year is considered dangerous. This article looked at records of almost 1 million people and found that, just from diagnostic studies, more than 4 million Americans each year have diagnostic radiology exams exceeding 20mSv per year, putting them on a path to having more than 100 mSv in five years if that dose is continued.

The Worst Offenders

Myocardial Perfusion Studies are the greatest contributors to these high radiation doses that create risk for patients. Abdominal Pelvic and Chest CTs also are major culprits and many of these exams are routinely encouraged "just to be safe" when the safest course may be to avoid these tests.

Understanding the Danger

The accompanying Perspective in the New England Journal points out that most doctors do not know of this danger. Only 9% of ER doctos knew that CT scans delivered high radiation doses that could be dangerous. It is estimated that diagnostic studies may cause 2% of all cancers each year. People should know that these tests aren't harmless and should only be done if they are likely to give results that will impact treament.

Tuesday, August 25, 2009

Ethics and Reform

Dr. Emanuel as Lighning Rod

In any political debate, each opposing camp always attempts to find and keep the moral high ground. In our current national discussion about health reform, Dr. Ezekial Emanuel has become a "lightning rod" in the words of an article published in the New York Times today. I have read a number of Dr. Emanuel's papers through the years , even writing about one of his articles in a recent posting that I made in this blog. Dr. Emanuel has communicated thoughtful and nuanced analyses on numerous difficult ethical topics and must be considered to be one of the best thinkers in bioethics today. I agree with the New York Times article that laments "how subtle philosophical arguments that have long bedeviled bioethicists are being condensed, oversimplified and distorted in the griddle-hot health care debate".

Challenges in Ethical Health Law and Regulations

However, the ethical considerations must be evaluated in any law that is proposed. The real challenge is that nuance in academic discourse must be translated into legislative language that is ultimately then translated into very specific regulatory language to enforce the new law. Shades of grey and individual judgments that are customized by the specifics of each person and each situation often fall prey to the black and white of staying strictly within the law and the regulations. The flexibilty that is often critical in interpreting ethics within the individual's situation may be easily lost to forms, protocol and "fairness" that may be ultimately unfair.

The Example of HIPAA

One need only see how the ethical goals of maintaining proper privacy and confidentialty has been lost in a sea of forms to sign and policies for health providers to follow with the implementation of the Health Insurance Portability and Accountability Act of 1996. Has the HIPAA law actually put a shroud around the teamwork that health care professionals have to use in order to best treat their patients by creating criminal penalties for intentional violations of privacy? Do patients really benefit from signing these forms? I don't know the answers however I do know that the HIPAA law is laudable in its intent but may fall short in its practice.

Health Reform Ethics

We need health reform. We also need to approach reform with pragmatism and care, understanding that strong goals and ethical thoughts alone, do not create good laws. To create good law there must be thoughtful attention to all the ways that the law will be implemented and the ethical outgrowth of those very concrete and tactical steps that follow the passage of any law. While the ethical underpinnings of the law may reflect pruity of purpose, the final result may be implemented without the ethics we anticipate.

Tuesday, August 18, 2009

The Need for Health Reform

Lest anyone misinterpret my previous blogs, I believe that our system is desperately in need of reform.  As I read President Obama’s opinion piece in the Sunday New York Times this weekend, I strongly agreed with some of the arguments he put forth to support health reform.  He highlighted a number of issues that are important to address in any health reform package and HR 3200 does effectively address those. 

Pre-existing Conditions Clauses

In that article, President Obama wrote “A 2007 national survey actually shows that insurance companies discriminated against more than 12 million Americans in the previous three years because they had a pre-existing illness or condition. The companies either refused to cover the person, refused to cover a specific illness or condition or charged a higher premium.”  While I would argue with the word “discriminate” as companies that do not discriminate and cover those with pre-existing conditions would have to charge higher premiums and would not be able to continue in business, the ability to exclude someone because of a pre-existing condition has been problematic for years.  If you speak to health insurance executives, they will tell you that they maintain those clauses in order to keep premiums low for select groups.  If you eliminate pre-existing conditions clauses, rates for many policies, especially individual and small group policies will go up.  Despite that I still believe that these clauses should be outlawed as they go against the basic premise of shared financial risk that is inherent in good insurance.  HR 3200, in Title I, Subtitle B, Section 111 does prohibit pre-existing condition exclusions and I see that as very positive. 

Policy Maximums

In that same article, President Obama states “They will no longer be able to place some arbitrary cap on the amount of coverage you can receive in a given year or in a lifetime. And we will place a limit on how much you can be charged for out-of-pocket expenses. No one in America should go broke because they get sick.”  What he is referring to in this quote is the yearly and lifetime maximums that some policies have in place.  A policy may now state that over the entire lifetime of the policy, it will only pay to a maximum of 1 million or 2 million or 5 million dollars and after that the benefits stop.  Obviously, if you have a severely catastrophic illness and go over that cap, you have no recourse other than some sort of public program.  Here again, eliminating these maximums will increase premiums for everyone, especially those who have individual policies and policies through small businesses.  However I am in agreement that this is needed to prevent people from compounding their illness with severe financial distress.  Section 122 of the same section of the bill that I cite above states that insurance coverage “does not impose any annual or lifetime limit on the coverage of covered health care items and services”  I see that as a plus and a needed change in law. 

Pass Those Clauses Now

There is really no reason that our legislators cannot pass these two sections now as a separate law.  There is no rule that makes all of the pieces of this legislation fit together.  We can find agreement for individual parts of the bill and I only hope that we can find the political will to make those changes that are needed.

Sunday, August 16, 2009

Comparative Effectiveness and Health Reform

The house health reform bill makes interesting reading once one gets past the arguments and into the details. One interesting section is Title IV - Quality, Subtitle A - Comparative Effectiveness Research, Section 1401, Part D. This section takes a mere 1 billion dollars (a very small part of the 1 trillion dollar total) to set up an infrastructure to fund and develop comparative effectiveness research. In the words of the bill, "a Center for Comparative Effectiveness Research to conduct, support, and synthesize research with respect to the outcomes, effectiveness and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically" will be established. It goes on to form a "Comparative Effectiveness Research Commission to oversee and evaluate the activities carried out by the Center to ensure such activities result in highly credible research and information resulting from such research". In other words, it sets up an oversight Board and a bureaucracy to develop, monitor and prioritize this type of research.

Comparative Effectiveness Research Today

One of the pioneers of effectiveness research for the past twenty plus years has been Dr. Robert Brook who has done his work at the Rand Corporation. In an article in July in the Journal of the American Medical Association, Dr. Brook clearly and concisely described what comparative effectiveness research really is. He gives a simple example to illustrate the research. "Consider, for instance, a company manufactures an improved surgical needle. Comparing that needle to the needle currently used could be included in comparative effectiveness research. A nearly infinite number of studies could be conducted to determine how often a person with back pain should receive chiropractic treatment, how often a person with hypertension should receive follow-up care, how often a patient should obtain a dental checkup, or what form of radiation and chemotherapy will achieve the best outcome for a patient with cancer."

In the article he goes on to describe guiding principles that should be used to ensure that the government funded comparative research does not turn into a "free-for-all or a full employment program for health services researchers and epidemiologists".

The Real Need for Comparative Effectiveness Research

I agree completely with Dr. Brook's approach and I encourage all to read it. I do, however have a different thought. How about comparative effectiveness research for legislation. Rather than just pass a health care bill, let's spend 1 billion dollars setting up a Comparative Effectiveness Research Center and Commission to fund studies on the comparative effectiveness of different bills and different government programs. I for one would love to know if paying for end of life counseling, as called for in HR 3200 actually results in people dying with more dignity and with more support from family. How about expanding it and assessing the comparative effectiveness of specific congressmen and senators? I really think we may be on to something with a bill like that.

Comparative effectiveness is a concept whose time has come. Let's just not limit it to medicine. I believe it is in assessing the outcomes of the work of our governing bodies where it is most sorely needed.

Thursday, August 13, 2009

The Health Care Reform Debate

The debate over health reform has degenerated badly and has become less about improving the health delivery and health insurance systems and more about which party can "win" and paint their opponents as evil or misguided in order to win future elections. We really have to change the tone of the debate and focus on the two problems that we are trying to solve. They are the problem of access to health care, especially for the 47 million Americans who currently have no health insurance, and the problem of high costs in health care. These are separate problems that will, in all probability need separate but coordinated solutions.

Access to Care

The number of 47 million uninsured is both true and misleading at the same time. If one looks more closely at those who are uninsured, they can be subdivided into certain subgroups. In the US census data from 2006, it was found that over 9 million of those uninsured have incomes over $75,000 per year. Another 8.2 million have incomes over $50,000. Many of the uninsured are young and while they can afford the coverage, don't see the need. We probabaly have about 18 million Americans who are truly uninsured and often uninsurable. Any number of people with no access to care is too many. As I read it, the current House bill is more directed towards solving this problem than towards solving the problem of high costs.

Lowering Costs

Total health care cost is a function of the unit cost of the services and the volume of services rendered in addition to our administrative costs and our amenity costs. While those administrative and amenity costs (which includes costs such as private rooms in hospitals) increase total costs they are not major contributors to our health care inflation. In order to lower costs, you have to lower the unit price of the services, which would mean lowering doctor's incomes, lowering hospital revenues, and lowering payment for new equipment, new drugs and other services or lower the volume of services that are rendered. In the United States, high tech and invasive services, such as MRI exams, surgeries, endoscpies and the use of new drugs have very high volumes and also exhibit the most "waste" as they often are used but often do not change the patient's outcome. Numerous studies have shown that these services and products are not useful about 30% of the time they are used. The volume of these services in the US exceeds other countries by 40 - 50% or more. In order to lower costs, we would need to lower these volumes signficantly. The challenge there is that while 30% of that volume is clearly unecessary, when programs are put in place to eliminate the unecessary care, needed care often also gets eliminated.

Putting the Two Problems Together

In many ways, the health reform debate is about the difficulties of adding millions of people to the health insurance system while also lowering the volume of services in total that are delivered to the population and still maintaining all needed care. This is an extremely difficult problem which inevitably forces decisions to be made about what care should be paid for and which care should not be paid for. The legislative instrument in making these decisions is rather blunt and that is a major part of our current dilemma.

There are ways to address the cost problem. One way is to remove the fee for service system that we have and move towards other payment systems that pay salaries for physicians or pay them in more "bundled" ways for the care of an illness. Under a bundled payment system, a physician or a health system may be paid for the complete evaluation and treatment of an illness (heart disease for example) and that payment would include everything from doctor's fees, to hospital costs to medications. Right now the evaluation and treatment of that heart disease includes sepaarate payments to multiple doctors in multiple specialities. All of those people, products and services would still have to be paid for in a more bundled system however such a payment system would create incentives to keep the costs of evaluation and treatment lower. However, make no mistake about it; the American public prefers incentives to do more over incentives to do less. We tend to prefer knowing that everything possible is being done when illness strikes. Finding a solution to lowering costs is thus a cultural challenge as much as an economic or political one.

How the Current House Reform Package Attempts to Solve the Problem of High Cost

To put it succinctly, it doesn't. It does address the issue of access by bringing many people into the health insurance system however the approach to lowering cost is mainly achieved by putting into place (for the long term) more electornic interfaces in medical record keeping and medical care, and also putting into place more government involvement in payment, benefits, and the development and maintainenece of medical care standards. Currently, the government does set fees, benefits and payment systems for Medicare and Medicaid. Most physicians and hospitals believe that the Medicare fees are very low and that the Medicaid fees may not even be enough to cover overhead expenses.

The example of End of Life Care

The loud debate over the end of life care provision in HR 3200 is a very good example of all that is wrong with the tenor of the debate and some of what is problematic in the bill itself. The goal of increasing people's options for themselves and their families at the end of life is a laudable one. As a physician, I have seen people have nothing but pain in their final days and weeks of life because they have not been given all of the options as to how they want to spend those finals days. Does the health care reform bill encourage a positive and loving way to approach one's final hours or does it result in government death squads? The reality is that it does neither. One really does need to look at the exact language in the bill to determine what is really being proposed.
Section 1233 entitled Advance Care Planning Consultation describes in excrutiating legal language all that must be done in order for a physician to charge for end of life counseling. It does not mandate the service but it does regulate it very specficially even describing the quality control for that service. This specificity can actually cause more fragmentation, at least in the billing process. A good physician does these services as a matter of course and can bill for it under the current billing system. It is an office visit. The troubling aspect of the provision is the attempt to push the physician into a script rather than encourage him or her to listen to their patient in order to understand their needs and counsel them in a customized personal manner. When government mandates specific language and approaches, costs can actually increase and the personal nature of medical care can suffer. So while I believe that end of life counseling is an important part of practice, I also believe that including it in the health reform bill will not further the goal of getting more counseling preformed in a personalized way. It will only increase administrative costs and fragment billing which also leads to higher costs. It may also further a troubling trend towards a depersonalization of medicine, at the time of life when the most personal type of service is needed.

So What Do We Do?

I hope that what we do is start to speak openly about the options and not just talk about being for or against health reform. We are all for improving the access to health care and making it more affodable and at the same time we are all for maintaining and improving the quality of care that all receive. The only question is what exact provisions need to be in the bill to best encourage those goals. There is honest disagreement about those provisions and I can only hope that the debate takes the time and care to evaluate each provision so that we end up achieving the best possible solution.

Sunday, August 9, 2009

The Patient's Story

Medicine and health care have never really been about the science. They have always used science but the real essence of medicine has always been in each person's story. An illness is never just an illness but it occurs within a person's entire life. The social, financial, spiritual, emotional and intellectual aspects of each person affects the illness and the illness affects all of these factors as well. More and more medical journals have understood this and more have been publishing first person accounts of these "stories" often written by doctors and occasionally by their patients, in order to give voice to the individual's unique story. The granddaddy of them all is the Narrative Matters section in Health Affairs which is perhaps the most prominent and widely read of the health policy journals. In honor of the tenth anniversary of Narrative Matters, Health Affairs in the latest issue has four narratives by wonderful authors including Abraham Verghese, Julia Alvarez, Alexander McCall Smith and Fitzhugh Mullen who was the original editor of Narrative Matters. As Ellen Ficklen, the current editor writes in her introduction to these four stories, "The peer-reviewed personal essays link a health care–related story or anecdote to the bigger picture. In doing so, underlying all of the undeniably important statistics and data involved in policy, they demonstrate the basic truth that health policy has human consequences." Not only does health policy have human consequences but medical care is always best when it understands the human being behind the disease. A strong narrative communicates this better than any medical text. Unfortunately, in todays world we have often left these narratives behind in the care for the patient. In a world in which we have ten minutes to see a patient and half of that time is spent looking at a computer instead of listening, finding a true unique person behind the symptom becomes next to impossible. I can only hope that the trend to communicate the story is part of a larger trend to bring true care and understanding back into healthcare.

Thursday, August 6, 2009

Sham Surgery

Studies in which patients undergo phony surgeries are always interesting to me. The moral dilemma of asking a person to take part in a study in which they are taken to an operating room, perhaps put to sleep or at least drugged to some extent and then "invaded" by a knife, a needle, a scope or some other medical instrument is, in and of itself troubling and yet fascinating. At the same time it is impossible to deny the valuable facts that can be found with such studies. In this week's New England Journal of Medicine, two such studies are published involving a procedure called Vertebroplasty which is a treatment for spinal fractures caused by osteoporosis. The procedure was found to have absolutely no value to patients. It is scary to think about how many other surgeries and procedures are done every day that may have no value and yet puts people at risk. At the same time it is also scary to think about doing more sham studies, putting people at some risk of sedation, site infection, and other risks both major and minor to further this type of knowledge. I hope that we always consider the moral dimension for individuals as we preform these types of studies and also hope that we can eliminate surgeries and procedures that do not add value to a person's care.

Monday, August 3, 2009

Obligation and Choice

Let's say you have a really bad disease, like cancer for example. A doctor comes along and asks if you will take part in a study but in order to do so, you will need to take medication but not know if it is real medication or a placebo that will not do anything. These types of studies are the heart of "double blind studies" that are core to clinical research. In other words you are being asked to be a guinea pig for the betterment of mankind and medical science. Do you have an obligation to say yes? According to the authors of an article in JAMA in July, you do! Schaefer, Emanuel and Wertheimer argue that for a number of reasons, the decision to participate in biomedical research as a patient is a moral obligation and not merely a personal choice.

While they are careful to make a distinction that it should not be a legal obligation, they say that if you answer "no" to my initial question and do not take part in the study, you are morally wrong. You are a bad person. I am troubled by that position. The standard approach to such questions is that an individual has the right to decide these issues for themselves and that the morality of the decision is not an issue and no judgment as to the morality of the individual making the decision is passed.

Perhaps I worry too much about the moral assuasion becoming a legal one but I want to keep my autonomy and not be pressured into taking part in studies that I feel are not valid, not helpful and not in my or societies best interests. I do not want to have a system in which people are shamed into taking part in studies that are designed more for the scientist doing the study and less for the patient. Let me make that decision on a study by study basis without the societal pressure that this article seems to endorse.

How do you feel about this? Let me know.


It has been a long time since I picked up the "pen" to write my blog. For any number of reasons, I have suffered from blogger's block (if such a thing exists). This month, an article in JAMA troubled me enough that I feel compelled to restart my musings, focused mainly on the sometimes brilliant and sometimes not-so-brilliant material that is published every day in the medical literature. I will post a separate note about that article.

In restarting, I feel the need to explain. My writings are mainly focused on new articles that are printed in the peer reviewed medical literature. The peer reviewed medical literature for those who are less familiar with the way medical progress moves forward, is the chief mechanism for new health knowledge to be distributed, challenged and ultimately accepted. A new fact is not considered a fact until it has undergone significant vetting through this literature, a neverending process to some extenet. I admit to a love of this genre despite it often being obtuse and difficult. My main goal in this blog is to take that sometimes incoherent body of writing and make it understandable to the general public. Think of me in this regard as a cross between a critic and an interpretor.

So I restart, renew and reinvigorate my blog. Here's hoping it creates clarity rather than more confusion.