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Uncle Sam: Do Your Research First

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

Extraordinary Physicians Honored For Advances In Medicine

castleconnollybannerI attended the fourth annual Castle Connolly National Physician of the Year Awards last night in New York City. It was truly moving to hear the incredible stories of triumph of each honoree – from military surgery (Dr. Judd Moul), to curing head and neck cancer (Dr. Carol Bradford), to expanding palliative care services for people not expecting a cure (Dr. Diane Meier) – each awardee embodied the very best character and principles one can hope for in a physician.

But perhaps most moving of all was the story of lifetime achievement award-winner, Dr. Emil Freireich. Dr. Freireich was born to Hungarian immigrants, his father died when Emil was 2 years old, his mother worked in a sewing factory to provide for his needs growing up. Through sheer grit and determination, Emil managed to get himself to college and then medical school. He began his career in 1955 at the National Cancer Institute (and has been working at MD Anderson Cancer Center since 1965) where he was provided a challenge: to cure childhood leukemia. Here is what Dr. Freireich had to say about how things have advanced in the field of leukemia in his lifetime:

In 1955 when I began my career at the National Cancer Institute, children diagnosed with leukemia usually lived for about 8 weeks. They had about a 1% chance of surviving a year – and they had a median age of 5 years old at diagnosis.

The worst thing about leukemia was not the short life expectancy, but the way the children died. You see, leukemia destroys blood platelets (the part of the blood that allows it to clot), and produces its own anti-coagulant. So every child with leukemia died of massive hemorrhaging. As a doctor in 1955, when I entered the leukemia ward, all I saw was blood. The children were bleeding in their urine, stool, lungs, and even from their eyes. They would cough to breathe and spew blood as high as the ceilings. The wards were red with death.

But now, thanks to years of research and the development of combination chemotherapy, leukemia is not a death sentence. In most cases it can be cured, and in all cases we can stop the bleeding.

The most rewarding part of my career has been treating young children with leukemia, and watching these same children grow up to become physicians who treat other children with leukemia. I have passed the torch on to them, and I believe that they will one day find the cure for other cancers too. I believe we will get there soon.

I had the chance to interview Dr. Freireich for this blog last year. You may read more here. Congratulations to all the awardees of the event – carry the torch high for us docs, we need more stories of hope like yours… and thanks to Castle Connolly for such an inspirational evening.

Lobsters Of Medicine

I’ve never cooked lobsters but was reminded of the trick to the recipe today: if you try to put lobsters into boiling water you’ll have a big fight and it won’t go well, but put them in cool water and slowly turn up the heat, by the time they realize there’s a problem they’re cooked.

I thought about this while turning sideways between gurneys in the hall to get through to the next patient of many.

The temperature in my ED continues to climb, but I’ve been here so long it just seems like it’s getting a little warm.

ED’s everywhere have rising census, increasing demands, physical plants that aren’t keeping up with the crush.

Coal mines have canaries.  Medicine has lobsters.

It’s getting warm, but there’s plenty of time.

Right?

Choice of Diet Does Matter

A recent article in the Journal of the American Medical Association (JAMA) reported that all diets that reduce calories work equally well. Of course that is true. Reduce calories, lose weight. The article suggested that it does not really matter whether you choose to lower your carbohydrates, your fat or whatever, just so you reduce your calories consistently over time. Like most large studies of weight loss, the overall results are disappointing in that most people do not stay with weight loss diets and the average weight loss is modest. That is because the people not staying with their diets dilute out those who lose a lot of weight.

What these studies miss is what your experience is with different diet approaches. How do thay affect your overall health? In my previous Blogs here, I have emphasized the importance of reducing simple carbohydrates, like sodas and sweets, since they drive hunger. It is very hard, probably impossible, to stay on a diet program if you are always hungry. Good protein sources, whether from dairy, lean meats, fish, nuts and vegetables, suppress hunger by causing your blood sugar to rise more slowly and remain more steady throughout the day. The rise and fall in blood sugar impacts your hunger. Finally, saturated fats are not good for your health and should be avoided in any healthy diet.

So, what you eat does matter. Your choice of foods will impact your hunger and affect how many calories you are likely to eat in a day. Your food choices affect more than your weight, but also your cholesterol and other risk factors for heart disease. When choosing a diet program for weight loss, make a healthy choice and choose a program that you can stay on for life. Afterall, weight control is a lifelong pursuit. You can vary your protein sources depending on your food preferences, and focus on healthy fats like vegetable oils and avoid the unhealthy satureated fats from things like hamburgers and french fries. Choose a diet program that works for you throughout the day and results in your not eating any more calories than you want to either to lose weight or maintain a healthy weight.

And remember, be physically active to burn those calories so you are more likely to lose unwanted weight.

**This blog post was published originally by Dr. Joe Scherger at eDocAmerica Blog.**

Acupuncture Doesn’t Work, Believers Ignore Evidence

steve_bwThe primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.

The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions.  Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.

There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.

These conflicting motives create a disconnect in the minds and behaviors of many people. They pay lip service to science-based medicine, but are good at making juicy rationalizations to justify what they want to be true rather than what the science supports. We all do this to some degree – but, in my opinion, complementary and alternative medicine (CAM) is a cultural institution that is built upon these rationalizations.  It is formalized illogic and anti-science conceals as science under a mountain of rationalizations.

Some recent news items and reports dealing with acupuncture demonstrate this disconnect quite well.

The BMJ

The British Medical Journal (BMJ) recently published a review of acupuncture studies in the treatment of chronic pain. Like most other reviews of acupuncture studies, the authors were not impressed. They concluded:

A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.

After decades of study and hundred of clinical trials, this remains the state of acupuncture research.  The best studies continue to show an unclear effect, which cannot be separated from bias – which of course is the point of clinical trials. In other words, the signal cannot be separated from the noise. The most parsimonious interpretation of this fact is that there is no significant signal – acupuncture does not work.

But supporters of acupuncture prefer to go through a litany of rationalizations rather than acknowledge that simple fact (more on this later).

It was also recently announced that the BMJ group will be adding a new journal: BMJ Acupuncture. That’s right, an entire journal dedicated to studying (read “promoting”) acupuncture.  The press release notes:

Acupuncture in Medicine is a quarterly title, which aims to build the evidence base for acupuncture.

I thought the purpose of research was to discover if a treatment works, not to build a case for it.

BMJ is a strange journal – it is generally of high quality but seems to have a blind spot for certain CAM modalities, like acupuncture. While it will publish critical reviews, like the one above, it also has published some low quality positive reviews – such as this one of acupuncture and IVF (in vitro fertilization).  The review glosses over the disparity in study quality and location. Other reviews published around the same time showed no effect from acupuncture in IVF.

And the best individual studies to date show no effect. In fact, the most recent study showed that the placebo acupuncture group had slightly higher pregnancy rates by some measures than the acupuncture group (while other measures showed no difference). Again – the most parsimonious interpretation of this study is the null hypothesis – acupuncture does not work in IVF. But proponents twisted themselves into logical pretzels and offered up the astounding rationalization that placebo acupuncture must have some real effect.

To be clear, I am not against journals that specialize in one area, or practitioners that specialize in one form of treatment. Specialization is essential to deal with the modern complexity of medicine. However, we must recognize the significant risk of specialization – and that is the fallacy that is often summarized as follows: if your only tool is a hammer then every problem will look like a nail. It is unlikely that a journal or practitioner dedicated to acupuncture will ever reach the conclusion that acupuncture is a dead end and science-based medicine should move on. As an extension of this, specialty journals and specialist should follow well-established modalities. Forming a specialty journal dedicated to an unproven and dubious modality is problematic, to say the least.

More Rationalizations

A recent Washington Post article observes in its headline: “Millions embrace acupuncture, despite thin evidence.” It seems this reporter, Ellen Edwards, has grasped the essential disconnect, although she does not sufficiently explore an answer to the implied question – why? Why do so many accept acupuncture despite an enduring absence of scientific evidence? Ironically, the press has much to do with it. They are often complicit in misrepresenting the facts, and abetting the rationalizations that are necessary for those who should know better to continue to promote acupuncture despite the lack of evidence.

Some professional organizations are also complicit. The article notes, for example:

The American Medical Association takes no position specifically on acupuncture; the AMA groups it with other alternative treatments, saying “there is little evidence to confirm the safety or efficacy of most alternative therapies.” It says “well-designed, stringently controlled research” is needed to evaluate its efficacy.

Now, the AMA is not the best place to go for position papers on specific scientific questions in medicine. But if they are going to bother having any position, it should be better informed. They say that research is needed, giving the impression that there isn’t already a large body of research to inform out opinion about whether acupuncture works or not.

The notion that more research is needed is one of the most common rationalizations. That allows someone to put off forever concluding that their pet modality does not work – simply make the case for more research, which is easy to make sound like it’s a good idea. And of course anyone against more research must be closed-minded.  For example, the story relates (standard disclaimer – I am aware that experts are often quoted out of context by journalists, so keep that in mind, but for the purposes of this post I will take the quotes at face value):

In 2007, NCCAM spent about $9.1 million on acupuncture research. While more is planned, Brent Bauer, an internist at the Mayo Clinic and director of its complementary and alternative medicine program, said the research is in its “toddlerhood.”

Nice touch – “toddlerhood.”  That’s just a cute way of saying that more research is needed and you can comfortably ignore any current negative research. If the assessment were fair, then it could be justified. But we have already had several fairly sophisticated placebo-acupuncture controlled trials. This represents reasonably mature clinical research. I suspect
Bauer just does not like the fact that these best studies (like the IVF study above) are generally negative. I wonder – if these studies were positive would he still think they were imature and could be ignored?

Linda Lee, a gastroenterologist who is director of Johns Hopkins’s new Integrative Medicine and Digestive Center, is quoted as saying:

“We have this double standard. We are completely comfortable using pharmacological therapies that have not been subjected to clinical trials for the purposes we use them, but we are super suspicious of alternative therapies that haven’t been tested with randomized placebo trials. From a research point of view, I understand the criticism. But we physicians are in the healing business, and we have to go beyond the pharmacological solutions to understand the whole person,” she said. “Acupuncturists start with the whole person.”

Ah – the “holistic” gambit.  This is just another rationalization to distract people from the uncomfortable fact, that she acknowledged. From a “research point of view” means “I understand that the best quality scientific evidence is negative.” And “we..are in the healing business” means “but I want to believe in this anyway.”

The double standard is also an incredible claim, because the opposite is true. SBM advocates want a single standard. What Dr. Lee is actually referring to is prior plausibility – scientific practitioners are more accepting of treatments that are biologically plausible, and are appropriately skeptical of treatments that are extremely implausible.  It is also a tu quoque fallacy – we advocate high standards of science for all treatments, even plausible ones. If some doctors uses drugs unscientifically, that does not justify chucking science whenever it conflicts with our beliefs and desires.

It is, in fact, the CAM proponents who want a double standard. Imagine if after hundreds of studies the best a drug could do for any indication is a weak effect that is likely just placebo – the signal cannot be separated from the noise. Imagine  a pharmaceutical company making the exact same rationalizations to put its failed drug on the market anyway that acupuncture proponents make for acupuncture.

The article concludes, as most do, with a positive anecdote from a believer – Elise Feingold:

“I decided to leave my science brain aside,” she said. “I felt it had helped other people, and it might help me. I don’t know how it works, but it’s got 4,000 years of Chinese medicine behind it.”

She begins with what amounts to saying that anecdotal evidence is more compelling that rigorous science. This, of course, makes no sense. The whole point of scientific rigor is for evidence to be more objective and reliable – to control for any many variables as possible. Anecdotes are unreliable because they do not control for any variables. Proponents of acupuncture are happy to cite scientific evidence when they think it supports their beliefs, but then will chuck science in favor of low quality anecdotes as needed.

Feingold finishes with the commonplace appeal to antiquity.  The premise of this argument is that a treatment that has no real effect could not survive for thousands of years. History proves that this premise is false (see blood letting), and it also profoundly underestimates the human capacity for self-deception and therefore the need for scientific controls.

Conclusion

There is still no compelling evidence that there is any real effect to acupuncture.  It didn’t have to turn out that way, but that is the way the scientific chips fell. The treatment also lacks plausibility (although I usually point out that something is happening, unlike homeopathy, and so there is the physical possibility of an effect), and in medicine you only get two strikes. No evidence and no plausibility means that you’re out.

But the disconnect continues. Proponents keep pretending that there is compelling evidence, or it has not been properly studied yet, or it does not have to be studied because historical anecdotes are enough – whichever argument suits the moment. Meanwhile the media keep breathlessly telling us that acupuncture is gaining ground, while the evidence is standing still.

The premise of SBM is that support and resources should follow scientific support. In the world of CAM, however, support follows belief, and the science seems to be an afterthought or, worse, an obstacle.

**This post was originally published at Science Based Medicine.**

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