May 20th, 2009 by SteveSimmonsMD in Primary Care Wednesdays
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The impetus for government to control healthcare costs should be obvious to us all and intervention now appears unavoidable. Two issues will soon come to light: the exorbitant costs to fight disease at the end of life, often when the approach of death is barely retarded and the wide disparity in costs between different geographical regions of our country for similarly aged patients. It is estimated that 27% of Medicare’s annual $327 billion budget – one fourth of its operating budget – goes to care for patients in their final year of life while Medicare averages $20,000 more dollars for patients in Manhattan than in some rural areas of our country.
With this in mind, I share a deep concern with many of my colleagues that part of the healthcare reform debate will turn to the rationing of healthcare. This appears a logical progression from the proposed establishment of guidelines and advisory committees currently allowed for in the Health Reform bill already passed. The question as to who should receive possibly futile care is not clear, rather it is fraught with complexity, often relying as much on evidence-based research as it is on assessments made by the medical practitioner in light of the relationship the doctor has with the patient.
At the heart of the rationing issue are two, often warring, sides of medicine: art and science. Medicine began as an art thousands of years ago, and moved more towards science when, in Ancient Greece, Hippocrates taught physicians to observe the results of their treatments and make adjustments. However, art should not be removed from medicine, for this is where the doctor-patient relationship comes to play, serving as a cornerstone of effective and humane medicine. It would be impossible for physicians to uphold the noble traditions of the medical profession, adequately serve society, or preserve the dignity of human life if doctors were to become, purely, scientists. As long as we are treating people, medicine should never become solely a science.
Rationing, however, would be based purely on science, completely devoid of any art and, I believe, serve as a blow against the sanctity of the medical profession. Setting up rationing guidelines as they pertain to the end of life would circumvent patient’s trust in the doctor-patient relationship and risk the very soul of medicine by negating the importance of the doctor-patient relationship. Evidence-based recommendations can and should be set forth pertaining to protocols for offering treatments as the end of life seems near. This would likely reduce some of the high and disparate costs in caring for our elders; however, it is important to consider the input of a doctor aware of the needs and desires of his patient.
I come to this argument both as a physician and from personal experience. Several years ago, my 75 year old father was hospitalized four times over five months. His medical team, led by a kind and experienced surgeon, unburdened by guidelines or anyone else’s recommendations, gave him a chance despite long odds against his survival. Medically speaking, I am still surprised he made it out of the hospital to live a normal life again. During the subsequent five years, he has welcomed three grandchildren into our family; I would challenge anyone to assign a monetary value for that life experience. My professional and personal experience leaves me quite sure that he would have fallen a victim of any rationing guidelines that could ever exist.
In short, as the average life span increases most of us nurture the hope to live longer, cheering as science opens the door to seemingly innumerable advancements. Yet are we, as a society, equipped, whether it be emotionally or fiscally, to handle the decisions that must be made as the end of life draws near? More importantly, should government be allowed to set up strict guidelines without an active debate from physicians and patients? These guidelines could sacrifice what has long been and should still remain most important to healthcare: the doctor-patient relationship.
May 6th, 2009 by SteveSimmonsMD in Primary Care Wednesdays
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Swine Flu has brought an awareness of the catastrophic potential inherent in pandemic influenza to the public consciousness and led many to panic. Industry has long played a major role in protecting us against epidemic influenza, providing doctors and patients with vaccinations and medications to help protect and treat the weakest individuals in our society: the young and old. However, pandemic flu frequently kills the healthiest in society; a hallmark of the 1918 Swine Flu Pandemic that left 500,000 dead in the U.S., far more that the average of 36,000 dead in a typical year.
This week, I had a discussion with Bill Enright, President and CEO of Vaxin Inc., about their efforts to create a vaccine for pandemic Flu. Our daughters are kindergarten classmates and over the last two years I have enjoyed the opportunity our friendship has afforded me to learn about the vaccine industry. As “Swine Flu” began to dominate the headlines I asked him to participate in a dialogue with me believing that a discussion between a clinical physician and a vaccine scientist would be interesting and informative for a reader without giving in to hysteria. He was kind enough to give of his own time and a part of the discussion follows:
STEVE: What is Vaxin, Inc.?
BILL:. Vaxin is a vaccine development company focused on needle-free vaccines to protect against influenza (both seasonal and avian influenza) and anthrax. Using technology developed at the University of Alabama at Birmingham, by our scientific founder Dr. De-chu Tang, we have been able to show proof of principle with our platform, intranasal seasonal influenza vaccine, and have just completed enrollment in a Phase I clinical study with an intranasal pre-pandemic influenza vaccine. We are also investigating patch-based vaccines.
STEVE: What is the difference between the vaccine you are developing for Pandemic Influenza and the vaccine given yearly for Epidemic Influenza?
BILL: Epidemic, or seasonal, vaccines are trivalent vaccines composed of three influenza strains (two A and one B) anticipated to be circulating. The CDC and the WHO spend considerable effort in monitoring the circulating strains around the world before making a decision on which strains should be included in that year’s vaccine. However, several changes could occur which result in the vaccine not being a good match for a particular year: mutations could change a strain, new strains could evolve or different strains than anticipated could predominate.
Pandemic vaccines will be made to the circulating influenza virus causing the pandemic. Vaccines made in advance of a pandemic are really “pre-pandemic” vaccines as they are attempting to estimate which influenza strain may make the jump to a pandemic and enable stockpiling and/or vaccination of at-risk individuals with the belief that the vaccine will mitigate symptoms and decrease mortality through cross-strain protection while a true pandemic vaccine is being developed/manufactured.
STEVE: How long does it take to produce an epidemic trivalent vaccine and is it feasible to have the current H1N1 strain or “swine flu,” included in the standard flu shot this fall?
BILL: That is a complex question. Do you include it as a 4th component? Replace one of the other A strains? Provide it as a separate vaccine? Manufacturers are currently trying to assess how much and of which type of vaccine they would be able to provide given a limited egg supply (since vaccine components require incubation in chicken eggs). Chicken populations take a significant amount of time to increase to add egg capacity. Seasonal vaccine antigen doses are typically 15µg and it takes approximately 1 egg for one, 15µg dose. To date it has taken 90µg of antigen to show similar levelsof efficacy for pandemic vaccines. Therefore, whether or not there is a sufficient egg supply and how that may impact the traditional epidemic vaccine is being discussed and calculated as we speak.
The length of time it takes to manufacture the epidemic trivalent vaccine depends a lot on the specific strains and how different the vaccine is from the previous year. For instance, the 09/10 vaccine will contain 2 of the same strains as the 08/09 version, only the B strain is different. The CDC put forward this years policy document on February 25th, identifying which exact strains were to be included in this year’s vaccine. Many manufacturers had already started the production efforts on the seed strains guessing that these would be the strains based on available surveillance of circulating strains. Typically the total process begins in December or January for most manufacturers. Usually the first vaccines are ready to ship to distributors in August or September. In certain years the process can take longer than usual because not all strains of influenza grow well in chicken eggs, including the recent H1N1 virus. New “reverse genetic” techniques are helping to alleviate this problem but the rate of growth and yield of virus continues to be a concern to manufacturers.
STEVE: Do you have any ongoing clinical trials for the H5 pre-pandemic flu?
BILL: Vaxin is currently completing a Phase I clinical trial for an intranasally delivered vaccine against the H5N1 influenza virus. This is the first step in getting a vaccine approved for use by the FDA. Typically Phase I trials involve a small number of otherwise healthy volunteers that agree to be vaccinated to allow us to test and ensure that our vaccine does not cause any serious unwanted safety concerns. Vaxin’s study involved 48 people that were divided into 3 groups of 16. Each group of 16 received a different dose of the vaccine on the first day and then received a second administration of a second dose 28 days later. Within each group of 16, only 12 people actually receive the vaccine and 4 people receive a placebo. Until the end of the study, no one knows who received the vaccine and who received the placebo.
STEVE: The mortality rates for H5 influenza have been between 30% and 70%. Did this lead you to choose H5 as a focus for your pre-pandemic vaccine?
BILL: The focus on H5 as a target for pre-pandemic vaccines is a result of the high degree of mortality seen in those that have been infected with the virus. While the 1918 flu had a catastrophic impact on the world and a large loss of life, it is estimated that the mortality rate was about 2%. However, it was able to spread very rapidly. Similarly, other pandemics from H2 and H3 outbreaks had relatively low mortality rates (estimated to be between 0.1%-0.5% for both the 1957 and 1968 pandemics).
STEVE: Can you speak about the delivery system you are using to deliver this vaccine?
BILL: Vaxin’s technology includes the use of another virus called adenovirus. This is a virus commonly found in nature which typically causes mild respiratory illnesses or cold like symptoms. It has a natural ability to infect humans at a very high rate. We have modified this virus so that it can no longer reproduce and we have incorporated a very small piece of the flu virus into the adenovirus. The adenovirus then infects people like normal but instead of making more adenovirus, it makes a piece of the flu virus. The body sees this in the same way it sees the flu…as a bad foreign protein and jump starts the immune system to get rid of it. In addition, our vaccine is given intranasally, the same way that the body normally sees both adenovirus and the flu. We believe the body responds in a very similar fashion in identifying and clearing the potential threat.
STEVE: Too many suffered complications to the H1N1 Swine Flu vaccine rushed through production in 1976; this leads me to ask if any corners would need to be cut, in terms of patient safety, to get a swine flu vaccine ready in time this year?
BILL: I am not familiar enough with the issues associated with moving the 1976 swine flu vaccine through the process to know about shortcuts taken, but the issues identified may still be issues. The result however was a significantly higher incidence of Guillain-Barre Syndrome (GBS) in those vaccinated vs those unvaccinated; 13.3 vs 2.6 per millions of people contracting Guillain-Barre, respectively. Note, significantly larger safety studies than are typically done for influenza vaccines would have been required to detect this event.
The current H1N1 swine flu vaccine would be against a very similar antigen and made with similar technologies for the most part and therefore the risk of GBS may still be prevalent. This will be weighed as a risk/benefit calculation when deciding how to proceed. It will depend in large part on the true mortality rate of the H1N1 swine flu vaccine. This was originally estimated at about 10%, but as identified cases of H1N1 and associated deaths are “confirmed” as opposed to being “probable” cases and the reporting becomes more accurate, it is now about 1% and falling. At 10% it is likely worth the calculated risk of GBS but at what point does the risk of death have a higher impact than the potential risk of GBS
STEVE: What percentage of health care workers, in our country, typically receive a flu shot?”
BILL: Only 36% of health care workers in the U.S. on average receive an influenza vaccine annually. (Source: CDC. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2003; 52 (RR8): 1-44.) Therefore, with a disease that can be spread two or more days before a person is symptomatic, an individual healthcare worker has a tremendous opportunity to spread the disease, without knowing it, to a population that is likely very susceptible, those that are sick and immune compromised to begin with.
STEVE: Do you have any suggestions for my colleagues and friends who tell me they get the flu from a flu shot?
BILL: It is scientifically not feasible to get the flu from a flu shot unless the vaccine has not been made appropriately and tested adequately. The licensed influenza vaccines on the market today are primarily inactivated whole virus or split subunit vaccines. Essentially the flu virus is grown in chicken eggs, purified and inactivated by heat or chemicals. The virus is unable to replicate and therefore cannot cause the flu. Usual side effects from any vaccination, because of the stimulation of a robust immune response from the body, include symptoms that some people associate with the flu, e.g., fever, body aches, sniffles etc. These symptoms are typical of many vaccinations including flu. Similarly in the new live virus vaccine (FluMist ®), the virus has been adapted to grow only in a cold environment. Once in the body its ability to replicate is severely limited and again not feasible to cause the flu.
All in all vaccines are the most cost effective medical procedure invented. Their use over the past century has saved millions of lives and untold expense with several previously common diseases now relatively under control or near complete eradication. Many people do not realize the annual cost, in lives lost, hospitalizations and subsequent economic costs, that influenza outbreaks inflict. Our ability to track and monitor influenza outbreaks and continual improvements in technologies and manufacturing processes are allowing us to attack influenza with the same vigor. While the world is more prepared than ever before to deal with potential pandemic influenza outbreaks, we still have room for improvement to ensure adequate, rapid access in all parts of the world. Vaxin is hopeful that our technologies and products will continue to advance this effort for rapidly available, safe, effective, easy to administer vaccines.
March 25th, 2009 by SteveSimmonsMD in Primary Care Wednesdays
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Anyone working in healthcare has a moral responsibility to do the right thing, for the right reasons, and at a reasonable price; however, this is not happening. Today’s healthcare system is too expensive and it is broken. If it wasn’t broken, the current administration would not be focusing so much money and effort on fixing it. Likewise, 42 million Americans would not be uninsured creating two different standards of care within our country. Many decisions have already been made: providing government backed insurance coverage for the uninsured, encouraging the use of electronic health records systems (EHRs), and creating comparative effectiveness research boards (CERs). Much of what has been suggested sounds good but was passed by our legislature before seeking the input of those responsible for implementing these new policies and plans. Fortunately, President Obama’s administration is seeking input now and it is the responsibility of anyone working within the healthcare system to speak up and be heard.
Many hard-to-answer questions should have been asked before solutions were posed. Why is healthcare so expensive? How can the intervention of government lead us to better and more affordable healthcare? Although integrated EHR systems may prevent the duplication of tests and procedures, how can medical practitioners best use these systems to prevent mistakes? How will future decisions be made – between doctor and patient, or will the new CER Boards grow to do more than merely advise? How would the American people react to more controversial ideas, such as health care rationing to control exorbitant costs incurred at the end of life?
In my last post, I closed with a promise to share some ideas regarding healthcare reform. First, we should try to reach a consensus as to what is broken before implementing solutions. In Maggie Mahar’s book, Money-Driven Medicine (2006), her concluding chapter is titled, “Where We Are Now: Everybody Out of the Pool.” This title screams for change as she makes a convincing argument that all parties involved in healthcare need to rethink how we can work together to fix a broken healthcare system which seems focused, not on healthcare, but on money. Today, Uncle Sam has jumped into the pool feet first, creating quite the splash, and he is spending large sums of money to lead healthcare reform without first reaching a consensus as to what is broken in this system.
The American Recovery and Reinvestment Act of 2009 will direct $150 billion dollars to healthcare in new funds, with most of it being spent within two years. Health information technology will receive $19.2 billion of these dollars, with the lion’s share ($17.2 billion) going towards incentives to physicians and hospitals to use EHR systems and other health information technologies. According to the New England Journal of Medicine, the average physician will be eligible for financial incentives totaling between $40,000 and $65,000; this money will be paid out to physicians for using EHRs to submit reimbursement claims to Medicare and Medicaid, or for demonstrating an ability to ‘eprescribe’. This money will help offset the cost of implementing a new EHR, which can cost between $20,000 and $50,000 per year per physician. However, after midnight, December 31, 2014, this “carrot” will turn into something akin to Cinderella’s pumpkin, becoming a “stick” that will financially penalize those physicians and hospitals not using EHRs in a “meaningful” way.
At our office, doctokr Family Medicine, we use an EHR, but consider it a tool, much like a stethoscope or thermometer, used to facilitate the doctor-patient relationship, not a tool to track our reimbursement activities. I would not argue against EHRs, but there is no evidence they will make healthcare more affordable and improve the quality of care delivered – unless you believe the $80 billion dollar a year savings “found” in the 2005 RAND study (paid for by companies including Hewlett-Packard and Xerox- incidentally, companies developing EHRs). I believe it will take far more than EHRs, financial incentives, and good data to fix our broken healthcare system.
Difficult decisions await those willing to ask the hard questions but don’t expect any easy answers to present themselves on the journey towards effective healthcare reform. My partner and I believe we have found answers to some questions and are moving forward, in our own practice, now. Asking why healthcare is so expensive and feeling frustrated with the high cost of medical software, we have written our own EHR, containing costs for our patients by keeping down our overhead expenses. Our financial model is based on time spent with the patient, not codes and procedures, which helps us to avoid ‘gaming’ the system and wasting time.
A familiar adage states that there are no problems, only solutions. I suggest, though, that there can be no solutions without problems. Find the right questions and opportunities abound. Earlier in this post, I asked how government intervention can lead us to better and more affordable healthcare. It can’t, at least not without the help and guidance of doctors, patients, industry, insurance companies, hospitals, and anyone who understands what is at stake with health care reform. We all share in the responsibility to try.
Until next week, I remain yours in primary care,
Steve Simmons, MD
March 11th, 2009 by SteveSimmonsMD in Primary Care Wednesdays
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Over the centuries, many societies have elevated the medical profession in thought and deed. Not that long ago this was true in the U.S., when our citizens showed more respect for doctors as professionals and fellow citizens than is demonstrated today. Now, everyone seems to agree that healthcare reform is drastically needed, and many are speaking out. Yet, the frank indifference to the opinions of doctors by those outside the medical profession mutes the voice and counsel of doctors on the subject. The AMA (American Medical Association) and many other physician groups are speaking out on reform, but their voice is diluted by a cacophony of assumptions, opinions, and by legislation existing and proposed. A new healthcare system has been formed, in large part, without seeking the input of those needed to make it work: practicing physicians.
Recently, I overheard a discussion regarding healthcare reform while eating lunch at a local restaurant. The debate hinged on who is most qualified to make healthcare-related decisions. The following consensus was reached: no one today should complain about the government taking over healthcare because allowing insurance companies to make all the decisions in the past resulted in a broken healthcare system. Those surrounding this particular lunch table agreed that the time had come for government to have their turn, while opposition could best be characterized as siding with the insurance companies. I wonder: can the debate really be so simply framed?
Saddened by the realization that such a discussion could be loudly and passionately debated without mentioning doctors, I resisted the urge to point out that physicians had made the healthcare decisions before insurance companies gained control. The fact physicians were not even mentioned attests to the sad truth that for many people doctors are merely seen as one part of a broken healthcare machine. Most physicians see their lot differently, and consider themselves as being in a veritable state of conflict with health insurance companies; however, our participation in a failing healthcare system has afforded these very same companies with the opportunity to put physician’s faces on their failed practices, with public opinion supporting this assumption.
Regardless of your opinion on Medicare, this last major government intervention into healthcare can help illustrate the very point that I am trying to make. On May 20, 1962, President Kennedy argued for Medicare, addressing a crowd of 20,000 at Madison Square Garden. The President was televised gratis by the three major networks reaching an additional 20 million people in their homes. Two days later, the AMA rebutted his argument, purchasing thirty minutes on NBC, with their speaker reaching an estimated audience of 30 million people. This broadcast, more far-reaching and influential than the President’s, delayed the proposed Medicare system by several years. Forty-seven years ago, people in this country wanted to know what doctors had to say before major decisions regarding healthcare were made. Today, they do not.
As the discussion about healthcare reform continues, practicing physicians must be heard from to interject real medical experience into the debate and, hopefully, guide the future of healthcare by influencing legislation existing and proposed. I am trying to remain optimistic despite the concern I feel in noting that the American Recovery and Reinvestment Act of 2009, section 3000 (pages 511, 518, 540-541) exemplifies the minimization of medical practitioners, using terminology like “Meaningful” ‘USERS’ to describe physicians.
The question is now raised: what should medical practitioners do to be heard, to influence healthcare reform, to play a leadership role in this time of change? When I write next time; I will share some of our ideas, put them on the table, if you will. But, I would encourage you to proffer those suggestions that you might have. It appears we can either speak up now or choose to be “meaningful” later.
Until next week, I remain yours in primary care,
Steve Simmons, MD
February 25th, 2009 by Dr. Val Jones in Primary Care Wednesdays
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By Steve Simmons, M.D.
Last week my partner wrote about The Funnel, and illustrated how patients are squeezed through a healthcare system that focuses on specific problems without allowing enough time to treat patients as individuals. We have shown how frustrating this is for doctors and demonstrated that a shortage of primary care physicians is a reality. However, we don’t believe it’s too late to reverse this foreboding trend. Today, my partner and I at doctokr Family Medicine are building a practice to care for our patients as individuals first. We have also added our voice to a growing chorus of physicians sounding ever louder, explaining the necessity of a healthcare system that places the art of caring for patients first.
The next time you sit in a doctor’s waiting room, look around and consider what, and more importantly who, you see. You might see a sick child or his worried mother. Our healthcare system does not see two people, rather it sees a 5-digit CPT and ICD-9 code. ICD-9 (International Classification of Diseases) codes were originally created by the World Health Organization (WHO) to track diseases across the globe. Today, CPT codes (designating patient difficulty) are combined with the ICD-9 codes by third-party providers to standardize the reimbursement process. Although over 17,000 ICD-9 codes exist to classify various illnesses, there is no code for compassion. More concerning, the system does not allow any time to ease the worries or fears of a mother.
The focus of a primary care doctor’s medical practice should be on the art of patient care. An individual should be treated as a whole and not the combination of their individual problems. But, a time may come when we must focus on one specific medical problem and seek the help of a specialist; such as an endocrinologist for diabetes or an orthopedist after an accident. Yet, without a primary care physician to coordinate our care and speak on our behalf, a patient’s wants and needs as an individual might not be considered in reaching a particular treatment decision. I can speak as a doctor, son, or patient when I say that anyone’s health can suffer at the hands of brilliant physicians working without the guidance of a coordinating physician who knows us well.
My mentor in medical school was an experienced family physician near retirement who offered me the following insight. There are two types of doctors and I would consciously or sub-consciously choose which one to be. One type of physician makes medical problems central in their patients’ lives and thus forces the individual to revolve around their problems. The other type works to keep the patient’s life central and tries to make problems rotate around the individual.
Those policy makers determining the future of healthcare should follow my mentor’s advice. Today’s health-care system has devolved to focus solely on problems and disease, often to the detriment of individuals and families. As decision-makers explore revamping our current healthcare system they could continue, unaware, in this same direction. But, I have to believe they would choose the other direction if they could remember how it feels to sit in a doctors waiting room surrounded by other people – individuals all. Nothing will change the fact that healthcare is ultimately about people, and not codes or a specific problem. Healthcare should help patients and their primary care doctors make good health and wellness decisions while basing them on an individual as a person.
Until next week, I remain yours in primary care,
Steve Simmons, MD
