During the healthcare reform debate there was the unfortunate reference to “death panels.” No such thing was ever in the proposals but it meant that an important part of medical care was set aside as too “toxic” to discuss. But end of life counseling is very important. Indeed it is good to have realistic discussions at the beginning of a serious illness; indeed it is only fair to the patient and the patient’s family.
Palliative care (I don’t like the term; it seems to imply only end of life care and so I prefer “supportive care”) is designed to achieve the best possible quality of care and the least suffering possible. This is not limited to pain management but also to psychosocial support, spiritual needs, the treatment of any symptoms, and assistance or at least support for decision making. It might be a complicated pain management program or a simple cup of tea in the afternoon to talk over important issues. Ideally it uses a team approach including physicians, nurses, social workers, psychologists, chaplains and others all working together. Palliative care teams have demonstrated their value in improving care and, interestingly, substantially reducing medical care costs.
There was a recent report of a controlled trail of palliative care. 151 patients with lung cancer entered a randomized trial when they first came to be treated in a thoracic oncology practice. It compared standard care to the same care plus a palliative care team. The results were clear that palliative care added to the patients’ quality of life; reduced the frequency of depression, the number of hospital days and even extended the survival by 2.7 months.
My experience, and others report the same, is that many physicians are uncomfortable with palliative care and tend not to refer their patients or if they do, not until very late in the patients’ course. Perhaps it gets at the deep inner concern that they do not want to be seen as “giving up” on the patient and perhaps it even forces them to admit that they cannot always cure every patient. Whatever, it is unfortunate because many people who could benefit from early referral to the palliative care team are not getting that benefit. Most large hospitals now have such teams; it behooves the patient or family to ask about them.
Read this book and you will want him to be your doctor. Or at least you will want to find a primary care physician like him who practices real relationship medicine the way he does and who assures you that you will have his or her undivided attention
Nanotechnology is making fast advances in medicine. I have written about it before here and in “The Future of Medicine – Megatrends in Healthcare.” A nanometer is one billionth of a meter. New science and technology based on the nanometer refers to the ability to manipulate individual atoms and molecules to build machines on a scale of nanometers or to create materials and structures from the bottom up with novel properties.Nanotechnology, according to the National Science Foundation, could change the way almost everything is designed and made, from automobile tires to vaccines to objects not yet imagined. The concept is to prepare “smart objects” that can invade small spaces and target specific parts of the body. Some researchers expect nanoscience to have a profound impact on the way medicine is practiced.
Here is a an infogram that gives a nice overview, compliments of its originator, Marcela De Vivo and her sponsor Associates Degree in Nursing.
I wrote an Op Ed for the Washington Times that ran today suggesting it is advantageous to us as patients when we pay our primary care doctors directly rather than depend on insurance. This returns us to the position of being in a direct professional financial contractural relationship with our PCP. It leads to better care, greater satisfaction and ultimately a major reduction in total health care expenses.
Here is the link
We hear that doctors do not like “protocol medicine” – they do not want to follow a “cookbook” when every patient is different. It is not a good understanding of the issues.
Some years ago when I worked in a branch of he National Cancer Institute and then the University of Maryland Cancer Center, we admitted many patients with acute leukemia. The treatment approach including the necessary special tests to obtain, chemotherapy drugs, steps to prevent infection, prevent kidney problems, etc was complicated. So I wrote out a set of admission orders, had them typed up, xeroxed and kept at the nurses’ station. When a new patient was admitted, the physician took one of those order sheets and either accepted each individual order or made changes. But the doctor now would not forget something important such as a drug, its dose or the number of times per day. This worked much better than depending on memory yet any specific order could be eliminated or modified as needed for the individual patient. This was not a “cookbook” but rather an improvement in both safety and quality.
Peter Pronovost and colleagues from the Johns Hopkins Bloomberg School of Public Health have worked on designing similar protocols for ICU patients for those needing the insertion of a central intravenous catheter to reduce the frequency of hospital acquired infections. This is basic stuff like gown and glove, use a disinfectant on the skin, use sterile materials, etc. It works; the infection rate falls by 60% if the guidelines are followed. Indeed in the Michigan hospitals where the technique was evaluated, the rate dropped to zero.
Remarkably, many doctors at hospitals across the country rebel at having those steps to follow using the same argument of “protocol medicine.” And equally remarkably, most hospital executives are hesitant to insist. They will need to become more assertive and physicians must accept the new standards. It is a matter of rights and responsibilities.
If physicians want the public (and elected representatives) to be supportive of malpractice tort reform, they will first have to accept “protocol or “cookbook” or “checklist” approaches that are tried and proven to improve quality and safety.
To summarize, there is a normal aging process wherein organs reduce their function by about 1% per year. This rate of decline is related, in part, to our lifestyles beginning when we are quite young. There are also age-prevalent chronic diseases that are also life style driven. Our personal agendas need to include attention to healthy living so that we can preserve wellness.
In the previous post I discussed the field of pharmacogenomics. Today I will focus on
Early and rapid diagnosis
Prediction of diseases to develop later in life
Genomics is proving to be very valuable in disease classification, especially with cancer. A pathologist’s evaluation looking at a microscopic slide has been the basis for most cancer classification – separating out breast cancer from lung cancer but then sub classifying each such as small cell and non-small cell lung cancer or the various subcategories of lymphomas. To this was added some years ago histochemical analysis to learn if a breast cancer was high in estrogen or progesterone receptors and then molecular diagnosis to find, for example, if the tumor had a high complement of the receptor Her2neu – each being important markers for the approach to treatment. Now genomics is adding an ability to delve much more deeply and find what the DNA mutations are in the individual tumor and how they are similar or different from others. This in turn is leading to searches for new drugs, as discussed last time.
This same work allows for early prognostication. Consider 100 women with breast cancer that appear by all the usual criteria to be the same type and of the same early stage. We know that most of them will respond well to current therapy of surgery, radiation locally and, in certain circumstances, systemic chemotherapy or hormonal therapy. But a small percentage will have a relapse. The problem is that there has been no way to determine in advance who is at risk of relapse. Genomics has begun to answer this problem. Analyzing the genomics of the tumor at the time of diagnosis, it is possible to separate these women into a good prognosis group and a poor prognosis group. The former rarely relapse and one might even consider if they need the same level of aggressive therapy as they are now getting. And the latter group is at high risk of recurrence; they are obvious candidates for clinical trials of alternate approaches to determine if relapses can be reduced. One such genomic prognostic test has been approved by the FDA and others are in the works for multiple cancers.
Genomics can be used for early diagnosis, especially in the field of infectious diseases. Remember the gentleman who flew to Italy on his honeymoon but who had tuberculosis? It led to an international concern that he might have infected others and that his TB might be of the drug resistant variety. One of the problems was that it takes about six weeks to grow the TB bacteria in the laboratory and then, if present, another six weeks to test for antibiotic susceptibility. But genomic tests can speed that process up to just hours. The TB bacteria (Mycobacterium tuberculosis) has a characteristic genomic profile so, if present in a sample from the patient, it can be detected within hours. And since antibiotic susceptibly is driven by the bacteria’s genes, they can be analyzed at the same time. A huge improvement in time to diagnosis and getting the right drug started from the beginning.
We might want to know if we are predisposed to develop a certain disease later in life. It is possible that genomics can be of real assistance here; indeed this has been a major “promise.” It turns out that most of the common, important diseases such as diabetes and coronary artery disease have not one but vast numbers of genes that have some impact on their development. So we will not find a simple answer for many of these. But as more is learned it is very possible that each of us will be able to learn our relative risk to some important and common illnesses. If you knew, for example, that you were at increased risk of heart disease, it might be a stimulus to you to be more diligent in eating a Mediterranean style diet, exercising more often and looking for ways to control stress- and it would be an added inducement to stop smoking. Similarly, if you were at risk for early onset colon cancer, you might be more careful to eat a diet high in fiber and low in fat and begin having colonoscopies at an earlier age.
These are just some of the advances coming from genomics; expect to see many more because genomics represents a true revolution in medicine and we have only seen the beginning.
Here is a video on medical megatrends
Gluten is not found in rice, corn, quinoa, amaranth or tiff. Despite its name, buckwheat does not contain gluten. Oats are gluten free but often raised near wheat or processed in mills that also grind wheat so they can be and often are cross contaminated.
There are three (possibly more) illnesses caused by gluten – celiac disease, gluten allergy and gluten sensitivity. Celiac disease is a serious life-modifying and often life-threatening disease. It is an autoimmune disease meaning that gluten sets up a reaction in a predisposed individual such that the body attacks its own cells. Not only can it cause gastrointestinal damage leading to malabsorption but it can lead to problems in multiple other organs in the body. Previously rather uncommon with no more than one person in 300 having the disease, today about 1% of Americans have celiac disease and the incidence appears to be rising still. It occurs in people who have a genetic predisposition, these being about one third of the population. But within that group of predisposed individuals, only some will develop celiac disease for reasons that remain unclear.
Gluten allergy is uncommon, affecting less than 1% of the population. It’s an allergy similar to how some people develop G.I. symptoms from, say, shellfish. Usually the reaction comes on quickly after eating, can be quite severe often with abdominal pain, nausea, vomiting and diarrhea. The reaction stops once the offending allergen (gluten) has passed out of the body.
Gluten sensitivity (or gluten intolerance) affects perhaps 10% and possibly more of the population. It ranges from rather mild to quite severe. The most common symptom is abdominal discomfort (“bellyache,” nausea, bloating) in two thirds of affected individuals. The next most common symptoms do not relate to the GI tract – eczema, “foggy mind,” headache and fatigue, all occurring in about a third of individuals. One third develop diarrhea when they eat gluten. Other less common symptoms are depression (20%), anemia (20%), numbness in hands or feet (20%), acid reflux and joint pains in about 10%. The severity of the symptoms seems to depend upon how much gluten is ingested at one time. The more one eats, the worse the symptoms. For some people the symptoms dissipate within just a few hours but, for others, problems such as diarrhea, reflux or even abdominal discomfort can persist for days or even weeks.
In a continuing care retirement community of about 2000 residents where I live, Charlestown probably has about 20 with celiac disease, a few with gluten allergy and 200 or so with gluten intolerance/sensitivity. Many will not be aware of the connection between their symptoms and gluten ingestion. The diagnosis is often missed by physicians because the symptoms can be vague. Many problems cause abdominal discomfort and many of the symptoms of gluten associated disease are not related to the GI tract, such as headaches or rash.
There are no medicines or pills to take. Whether it is celiac disease, allergy or gluten sensitivity, the only effective approach is to totally avoid gluten.
Aortic stenosis (a narrowing and hardening of the heart’s aortic valve) is not uncommon among older individuals. It begins without symptoms and progresses for years but, about 50% will die within 2 years once the fitst symptoms develop. The standard approach is to surgically replace the aortic valve which will improve both heart function and survival. Unfortunately, about 30% of symptomatic individuals cannot undergo surgery because of older age, other heart problems or other medical conditions that render surgery too risky.
A new approach is called transcatheter aortic value implantation (TAVI.) In this procedure, a catheter is inserted into the large femoral artery in the groin and run up to the heart. From the catheter, the patient’s valve is opened wide with an inflatable balloon. Then a bioprosthetic value made from bovine pericardium affixed to a stainless steel support frame is deployed into place via another balloon catheter and secured to patient’s own aortic valve base.
A randomized study of 358 patients with aortic stenosis not considered surgical candidates was completed comparing TAVI to standard therapy at 21 medical centers and reported in the New England Journal of Medicine on October 21, 2010. The results were clearly favorable. Standard therapy was noted to not alter the natural history of aortic stenosis with 51% dead in one year. TAVI was superior with improved cardiac symptoms and good hemodynamic performance of the new valve which persisted for at least the first year of follow-up and with 31% dying during that year, a substantial decline in mortality.
But there is never a “free lunch” and TAVI was associated with a 5% risk of serious stroke (compared to 1% in the control group) and multiple vascular complications, the latter apparently related to the requirement for a large catheter placed into the femoral artery. Further MRI studies of patients suggest that many have new perfusion defects of the brain after TAVI suggesting that emboli from the new valve may be rather common.
But all things considered the improvement in symptoms and the reduced death rate (it took only 5 patients treated with TAVI to avoid one death by 1 year) argue that TAVI is now the appropriate therapeutic approach for those with aortic stenosis who cannot otherwise undergo surgery. Hopefully, coming improvements in the device will lead to fewer complications.
The big question – will this become the approach of choice for those who otherwise are candidates for standard surgery for aortic valve replacement?
Health care should be a right but it needs to be paired with some responsibility – some share of the cost, especially for routine care, and some attention to maintaining a reasonably healthy life style. To do so will not only lead to better health but reduced expenses overall – positive outcomes for all.
One of the major goals of the Affordable Care Act is to reduce the number of uninsured from the current about 50 million people (or 16+% of the US population) by both offering Medicaid to many more individuals and creating state-based insurance exchanges for individuals who cannot obtain insurance at their worksite. Medicaid will be available for those at <133% of the federal poverty rate (currently $22,050). The insurance exchanges will be available to everyone but those with income below 400% of the poverty level ($88,200 for a family of four) will be eligible for tax credits based on actual income. Unlike Medicaid which has essentially no cost sharing by the individual, insurance from the exchanges will be purchased at one of four levels – 60, 70, 80 or 90% of the approved covered expenses will be paid by the insurance; the remainder will be the individuals’ responsibility. Higher deductibles will likely correspond to lower premiums.
The Institute of Medicine (IOM), at the request of the Department of Health and Human Services, formed a committee to consider the process for defining “essential health benefits” which ultimately will translate into what is covered or not by the insurance from the exchanges. The IOM, wisely in my opinion, emphasized he need for affordability rather than just comprehensiveness. They argued that coverage should be “evidence-based, specific and value promoting over time.” They proposed that medical necessity should be based upon clinical appropriateness, best scientific evidence and a likelihood of providing an “increased health benefit…that justifies an added cost.” [For a fuller discussion of the IOM recommendations, see John Iglehart’s article in the New England Journal of Medicine, Oct 20, 2011]
These seem like wise and sensible proposals. Too often there has been a “push” to insist on very comprehensive coverage, little attention to evidence-based criteria and little or not cost sharing by the patient.
My own hope is to see insurance that carries high deductibles to encourage each of us to personally monitor our health expenditures. When we have our own money at stake, we are more likely to ask our physician if that MRI, procedure or specialist visit is really needed of if it is “just to be complete.” That high deductible may also encourage us to maintain a better life style and maintain our health. That is good for us and reduces the overall costs further.
My new book discusses these topics in detail – “The Future of Health Care Delivery, Why It Must Change and How It Will Affect You” will be published in Feb, 2012 by Potomac Books
Adhering to a moderate yet healthy lifestyle can reduce the risk of sudden cardiac death by about 90% according to a new study. It is well known that high blood pressure, high cholesterol, and diabetes correlate with coronary artery disease. Life style factors do as well – a combination of a Mediterranean style diet, moderate regular exercise, appropriate weight and non smoking all correlate with less coronary artery disease, less stroke, less high blood pressure, less diabetes, less cancer and multiple other chronic conditions and lower (or later) mortality overall.
These same factors have now been demonstrated to also reduce risk for sudden cardiac death, i.e., a sudden arrhythmia that leads to death in less than an hour from symptom onset.
S. E. Chiuve, etal of Harvard and the Brigham and Women’s Hospital in Boston (JAMA, July 6, 2011, p62) evaluated sudden cardiac death (SCD) among 82,000 participants in the Nurses Health Study between 1984 and 2010. 321 individuals had SCD during those 26 years at an average age of 72.
The authors set out four criteria for low risk lifestyles: not smoking, BMI <25, exercise >30 minutes per day and being in the top 40th percentile of the alternate Mediterranean diet score. In essence, the latter is a diet rich in fresh vegetables and fruits, nuts, whole grains, legumes and fish with moderate intake of alcohol.
The results were clear. The more risk factors, the greater the rate of SCD. Stated differently, “a low risk life style (not smoking, exercising regularly, having a prudent diet and maintaining a healthy weight) was linearly and inversely associated with risk of SCD among women.” Those women who had all four low risk lifestyle attributes experienced a 92% lower risk of SCD compared to those who had no low risk attributes. This suggests that the vast majority of SCD could be prevented by life style modifications.
The study authors point out that although 80% of women do not smoke today, adherence to the other three factors is low. Less than 40% of middle aged women have a BMI <25, 25% drink light to moderate alcohol and only 22% exercise regularly. And although the data on diet habits is limited, a simple observation of what is purchased in the supermarket is telling.
It is evident from this study – and many others – that managing lifestyle factors can prevent serious chronic illnesses including coronary artery disease, cancer, stroke, high blood pressure and diabetes along with sudden cardiac death. This is true even for those with a genetic predisposition – “your genes need not direct your fate.”
Much of today’s foods are “ultraprocessed,” lead to obesity and its ultimate diseases such as diabetes, coronary artery disease, hypertension, many cancers and worsening of diseases such as osteoarthritis.
Ultraprocessed foods originate from just a few grains, namely corn, wheat and soy but these then undergo extensive chemical and mechanical manipulation resulting in compounds that humans have never eaten before. Just look at the ingredients list on many store products and notice first how many ingredients are listed and second how few of them you recognize. Further they are concentrated as to sugars, salt and calories while deficient or totally lacking in the fiber, micronutrients and phytochemicals found in fresh or frozen grains, vegetables fruits and unadulterated meats and fish.
David Ludwig MD, PhD of Boston Children’s Hospital wrote a cogent article on ultraprocessed foods in the April 6, 2011 edition of the Journal of the American Medical Association and upon which the proceeding was based. He explains that there have been three major breakthroughs in food technology. The first came perhaps 2 million years ago with the development of stone tools and the use of fire for cooking. This allowed the human who did not have the running speed of large carnivores nor the digestive tract attributes of herbivores like cattle and sheep to expand his diet. The second big technology breakthrough was domestication of grains – agriculture. This led to civilization in the sense of larger more stable communities because domesticated grains such as wheat and corn greatly increased calories available and no longer required migration to hunt or gather. He makes the interesting observation that human stature dropped a few inches with this change because grains carry fewer micronutrients and protein per gram than do animal meats and nuts.
The industrial Revolution was the third breakthrough technology which led to refined flours and concentrated sugars along with grain-fed rather than grass fed cattle, sheep and hogs. Such animals are heavy with saturated fats although their protein content and ready availability has resulted in a return of greater stature in recent generations. More recently have come ultraprocessed foods.
These ultraprocessed foods are high in calories from sugars and fats – often hydrogenated and trans fats – yet low in micronutrients. They are found in supermarkets’ “middle aisles” as processed foods such as cereal with added sugar, cheese “spreads”, “macaroni and cheese,” soups high in salts and calories, “sticky buns,” and of course sugared sodas. And ultraprocessed foods are readily available in many fast food outlets where a muffin may have 400 calories with high contents of sugars and saturated fats. A bacon cheeseburger, large fries and large soda can contain well more than one half of a day’s caloric needs yet be deficient in nutrients.
Ludwig concludes with “the problem is the creation of a dietary pattern based on factory-made, durable, hyper-palatable, aggressively marketed, ready-to-eat or heat foodstuffs composed of inexpensive, highly processed ingredients and additives. Reducing the burden of obesity-related chronic disease requires a more appropriate use of technology that is guided by public health rather than short-term economic benefit.”
What can we do? We need to cut back on the ingestion of these ultraprocessed foods. But this will not be easy. For this to work I believe we need incentives. After all, that bacon cheese burger tastes good – sugar and fat are pleasing in our mouths. So we need more than just knowledge that we are eating well and thereby preventing future disease while improving our health. Knowledge is important because most people just do not realize the extent of the harm that comes from over consumption of ultraprocessed foods. With knowledge we can follow the advice of Pollan in his “In Defense of Food” to never buy a product that has more than five ingredients or has ingredients that we have never heard of or cannot pronounce. But knowledge alone is just not incentive enough to overcome the temptations.
Some thoughts: Government can help with how it subsidizes agriculture, incenting the growth of a broader array of crops and not marking the fattest meat as “prime.” And it can continue to insist that restaurants, especially fast food outlets, display calorie counts. Business can help with wellness programs that reduce the employee share of health insurance premiums in return for weight reduction or exercise programs. Insurance can offer incentives as well. Schools can offer only quality foods – good in itself but also a lesson in good dietary habits for our children in their formative years. And we each need to create our own incentives – as I typed this I also ate a chocolate chip cookie. I enjoyed it but have set myself a limit of one per day. My treat for finishing this blog post.
Drug companies can use genomics to create targeted drugs like imatinib (Gleevec) and trastuzumab (Herceptin.) Physicians can then use the results of genomic studies to guide prescribing. As discussed in prior posts, a person with Philadelphia chromosome-positive (i.e., having the BCR-ABL translocation with its aberrant tyrosine kinase) chronic myelocytic leukemia will likely respond to Gleevec. And a woman whose breast cancer shows high levels of the Her2neu receptor will likely respond to Herceptin. There would be no reason to treat a Philadelphia chromosome-negative CML patient with Gleevec nor a breast cancer patient without Her2neu receptors with Herceptin.
Recently the treatment of lung cancer has advanced considerably as a result of genomic analysis of the tumor and the development of targeted drugs. Lung cancer is divided into a number of different categories based on the microscopic appearance under the microscope. One type is called small cell and the others are usually “lumped” together as “non small cell” lung cancer because the former is treated much differently than the latter group. The non small cell lung cancers can be genomically evaluated to determine if there are certain common genetic mutations such as KRAS, EGRF, MEK and other mutations or the EML4-ALK translocation.
Patients with the EML4-ALK translocation respond reasonably well to the tyrosine kinase inhibitor crizotinib (somewhat similar to the one used for CML). As with the translocation seen in CML, this is a fusion gene that occurs during a translocation of two parts of two chromosomes that lead to a portion of the normal EML4 gene being fused next to the normal ALK tyrosine kinase gene. When this happens the new gene transcribes a variant tyrosine kinase protein which leads in part to the development or progression of lung cancer. Studies to date indicate it to occur mostly in the subtype called adenocarcinoma, in those with prior treatment, in younger patients and those who have no or a minimal smoking history. Although this represents just a small subset of all lung cancer patients, treatment of them in a Phase 1 trial with crizotinib resulted in a confirmed response in 57% (47 of 82) of patients with another 33% (27 of 82) having stabilized disease. [Kwak et al, New England Journal of Medicine, Oct 28, 2010] Although not a randomized trial, it is well known that most second line treatment regimens have no better than a 10% response rate so this would appear to be a breakthrough of sorts. Certainly it is not a panacea, nor a cure. But with minimal side effects these patients received some useful benefit and probably will have a lengthened survival Further studies will need to be done but if it is correct that about 5% of lung cancer patients have this fusion gene, then about 9000 patients per year would potentially benefit form crizotinib or similar ALK kinase inhibitors. Concurrently, one would not choose to use this drug in patients without this fusion gene and its abnormal protein. It also appeared that some patients had a further mutation such that crizotinib was not effective in them. [Note: Crizotinib is not yet approved by the FDA so access to the drug is via clinical trials.]
Patients who have the EGRF mutation appear to be distinct from those who do not as to response to the drugs erlotinib (Tarceva) and gefitinib (Iressa). EGRF is a tyrosine kinase that when mutated appears to play a role in lung cancer development and progression. Those who do have this mutated gene and its transcribed protein will respond to these two drugs in about 70% of cases with progression free survival of about a year and total survival of about two years. This would appear to be superior to standard drug therapy used today. Without this mutation, the patient will do much better treated with chemotherapy. So the treatment of a new patient with lung cancer today should include genomic analysis of the tumor so that the patient can receive the most appropriate first line treatment and then reanalysis later to determine if there are further mutations or translocation that would direct second line treatment options.
This is just one more example of how genomics is making medical care more custom-tailored, one of the five key medical megatrends.