Wednesday, July 10, 2019

Do I really need those vitamins?

Americans love their vitamins and “nutritional supplements.” Surveys have shown that over half of us take at least one and 10% use at least 4 dietary supplements daily. Among those 60 or older, use is even higher; 70% take at least one and 29% take four or more supplements. The market is huge, in the billions of dollars, and “brand extension” is common. You can buy multivitamins, multivitamins for women and multivitamins for seniors. Vitamin D capsules crowd the shelves with sizes from 1000 units to 4000 units and more. Ever since chemist Linus Pauling pronounced it a miracle, millions of us use Vitamin C to prevent or cure a cold.
Besides making money for the manufacturers, pharmacies and GNC, do vitamins and supplements do any good? Clearly it is important to replace any deficiencies. If you have pernicious anemia, (https://www.whatswrongwithhealthcareinamerica.com/2019/06/b12-deficiency-great-imitator.html ) you need Vitamin B12, either by injection or in very large doses by mouth. If you do not drink milk and avoid the sun, you may well need to take Vitamin D. If you are a woman with very heavy periods, a daily iron supplement may be needed. Certain vitamins have been shown helpful in slowing the advance of macular degeneration.
What about the vast majority of supplement users? Most people who take these products take a multivitamin, but rarely is that the only product used. Other commonly used supplements are omega-3 or fish oil, calcium, Vitamin D, Vitamin C and botanical products. Ironically, but not surprisingly, supplement users are much more likely than non-users to say that they try to eat a balanced diet, see their doctor regularly, get a good night’s sleep, exercise regularly and maintain a healthy weight. Many studies over the years have looked at the benefits of taking various forms, particularly at their effect on cardiovascular disease, still the number one killer in western countries.
A recent study published in the Annals of Internal Medicine looked at 277 trials involving 24 supplements or combinations of supplements and almost 1 million subjects. These studies found that reduced salt intake lowered the death rate in all and cardiovascular death in subjects with hypertension. Omega-3 long-chain polyunsaturated fatty acid (LC-PUFA) reduced the risk of coronary disease and heart attacks by a modest amount (7-8%). Use of folic acid was associated with a 20% decreased rate of stroke. Somewhat alarmingly, use of calcium plus Vitamin D was associated with a 17% increased risk of stroke. All the other supplements, including Vitamins B6 and A, multivitamins, “antioxidants” and iron had no measurable benefit. Some 25% of us over 50 take a supplement touted as good for "brain health," but the AARP Global Council on Brain Health has come down strongly against this practice, calling it a "massive waste of money."
Bottom line? Don’t waste your money. If you eat a balanced diet, the odds are you are getting all the nutrition you need. If you feel better taking a multivitamin, there is no evidence it does you any harm, but you are better off choosing the house brand and saving money. If you are shoveling down 8 or 10 “supplements” daily, you are probably wasting your time and money.

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Wednesday, July 3, 2019

Is dementia the price to pay to be dry?

First, a little background and terminology. Our brain cells talk to each other via “neurotransmitters.” One of these is a compound called acetylcholine. There are two relevant classes of medication that act on acetylcholine. One group are anticholinergic drugs, which block the effect of acetylcholine. These are used in many ways, and there are many subgroups. They are used to treat vertigo and nausea; they are used to prevent seizures; they include many of the older antidepressants, antipsychotics and antihistamines; they are antispasmodics for the intestine, and notably, they are used to treat urinary incontinence. The other class of drugs are cholinesterase inhibitors. The chemists among you will figure out that these block the breakdown of acetylcholine and so increase its effect. The best-known of this class are the drugs used to slow the progression of Alzheimer’s Disease.
It has been long-known that use of anticholinergics can cause confusion in elderly patients, and doctors have been taught to use these cautiously. What has not been known is if they have any long-term effect in patients who seem to tolerate their use. A study published online in JAMA Internal Medicine in June looked at this by studying a very large (30 million patients) British research database. They compared patients diagnosed with dementia with those who were not, matched by age and gender. They then looked at use of any of over 50 drugs with anticholinergic properties by type and by duration of use. They found that patients with dementia were much more likely to have been prescribed an anticholinergic drug over extended periods than were controls. The drugs that most clearly showed this effect were from the group that were expected to be used daily for a long time.
I would like to call your attention in particular to the group of drugs used to treat urinary incontinence. I do this because they are very widely advertised and widely-used by middle-aged and older women. They tend to be used for indefinite periods. They are also of marginal benefit at best. Many of the other drugs in this class are of less current concern because they are used only infrequently (anti-nausea, muscle relaxants) or because they have been largely replaced by newer drugs (tricyclic anti-depressants). Bladder problems are very common and while not life-threatening can be annoying and embarrassing. Oxybutinin (Detrol and other brands) is probably the most widely-used drug to treat overactive bladder. It universally causes a dry mouth, such that the increased thirst works against the desire to void less often.
While this was an “observational study,” and not a randomized trial, it has some inherent validity. We know that anticholinergics can cause confusion in some users. We know that acetylcholine is important in brain function. We know that drugs that increase acetylcholine have some benefit in dementia. My advice is to use these drugs only if other remedies have failed and only if the benefit is very strong. If your reaction is “well, it seems better than nothing,” I’d think twice. Maybe a pantie-liner would do as well and be safer.

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Monday, June 24, 2019

Better than roses?

On June 21, the FDA approved for marketing bremelatonide (trade name Vyleesi) to treat acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
While I expect push-back commenting on this topic as a male, I am also a physician, and I think this represents a flaw in our drug-approval process. HSDD is defined in the psychiatrists’ “bible” of DSM (The Diagnostic and Statistical Manual of Mental Disorders is the handbook used by health care professionals in the United States and much of the world as the authoritative guide to the diagnosis of mental disorders) as low sexual desire that causes marked distress and/or interpersonal difficulty and which is not due to a co-existing medical or psychiatric condition. It can be diagnosed in both men and women, though I am unaware of any products marketed or in development to increase male sexual desire. Vyleesi is not the first medication for improving women’s sexual desires. Addyi, a drug approved by the FDA in 2015, also improves women’s sexual desires by working kind of like an anti-depressant. However, earlier this year, the FDA issued new safety orders mandating that the drug’s labeling include a boxed warning — the agency's strongest warning — after reports of concerning side effects, including severely low blood pressure and fainting, especially when used with alcohol. Many women’s groups were and remain unhappy that Addyi was approved as quickly as happened.
Changes in sexual desire are natural and may come and go depending on personal events or partner-related issues. When the lack of interest in sexual activity lasts longer than six months and causes distress, however, the criteria for a sexual desire disorder may be met. There are many reasons other than a “medical disorder” such as HSDD to cause decreased interest in sex. These may include, in part, negative attitudes about sex, relationship difficulties (poor communication, abuse), stresses such as financial difficulties, job loss, bereavement, etc., history of emotional or physical abuse, alcohol use, worry about children wandering in or simply a partner’s poor hygiene.
Leaving this all aside, how wonderful is Vyleesi? Is it a “cure?” The drug was approved based on two trials that compared the active drug in different doses versus placebo. The drug must be injected under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity (so much for spontaneity!). Possibly showing the power of placebos, the trials found that 25% of women using active medication had an increase in their sexual desire scores, compared to 17% of those using placebo. 35% of women who used the drug had a decrease in their distress score versus 31% of those using placebo. While the manufacturer will tout the “47% greater improvement” experienced by women using the active drug (17% increased to 25%), I think a more realistic viewpoint is that the drug benefitted 8 out of 100 women who used it.
What about side effects? About 40% of the women in clinical trials experienced nausea, and in 13% the nausea was severe enough to require medication. It also caused a transient (up to 12 hours) increase in blood pressure, meaning it should not be used in women with high blood pressure or cardiovascular disease. The drug will go on sale in September, and a price has not yet been announced.
Worth it? You can decide for yourself, but I’d try roses first.

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Thursday, June 20, 2019

Be nosy - read about yourself

For centuries, doctors felt that their notes were their property, and none of the patients’ business. This attitude slowly shifted, and the Health Insurance Portability and Availability Act (HIPAA) of 1996 put into law the fact that patients must be allowed to review and get copies of their medical records. Despite this, access to records has remained a daunting task for many. A study done in 2017 of 83 hospitals, all “top ranked” by US News and World Report, found that the information patients were given by phone often differed from that on the forms they had to sign, and that a majority of hospitals charged well over the federally-suggested cost for an electronic copy. Many refused to supply records in the format patients requested, even though this is mandated by law.
Is it worth the bother? Increasing evidence says that you should read your own medical records. There are many benefits. A common failing of current Electronic Medical Records (EMRs) is that they are filled with cut-and-paste from prior notes and often propagate misinformation. An old note says you had an appendectomy as a child and this is carried forward indefinitely, even if you still possess your appendix. Ditto for medicines you stopped taking eons ago, and allergies you never had. If for no other reason, it is worth looking through your record for such mistakes and having them corrected.
Beyond correcting errors, there are many benefits to reading your own records. Some seven years ago, researchers looked at how both doctors and patients reacted to completely “open notes.” Patients at three primary care practices, in Massachusetts, Pennsylvania and Washington State, were given complete access to their doctors’ notes via a secure portal. Included were 105 PCPs and 13,564 of their patients. 11,155 patients opened at least one note, and almost half of these completed a survey on their reactions. Over 80% reported that open notes helped them feel more in control of their care and three quarters of those taking prescription medications said that they were more regular with taking these after reading about their condition. About a third said they shared the notes with others. On the down side, a third had privacy concerns, worrying that others might get into the records and about 5% found something in the notes that was worrisome or offensive. At the end of the experiment, 99% of the patients wanted open notes to continue. The doctors were initially hesitant, but only rarely did the practice result in longer visits or more time addressing issues outside of visits, and none opted to stop when the experiment ended.
One of the biggest problems in patient-physician interactions is that patients find it hard to process all the information they are given during a visit, and it has been repeatedly shown that much of what a doctor says is quickly forgotten. I have advised people to take notes during visits and/or to bring a friend or relative with them as a second pair of ears. Having the ability to read and reread notes of the visit is another good way to be sure you truly know what happened at the visit.
Be an “engaged” patient. Read those notes.

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Thursday, June 13, 2019

News you can use

Several studies reported this week in medical journals had useful findings that should be widely known.
Beware of bats! The CDC reported on human rabies in the United States. Between 1960 and 2018, a total of 125 human rabies cases were reported. 36 were attributed to dog bites, all of which were bites that happened when the victims were travelling abroad. Since universal vaccination for pets was adopted decades ago, rabies in domestic pets has almost vanished. 89 cases were acquired in the U.S, and 62 (70%) of these were contracted from bats, that are by far the leading carriers of rabies in this country. Racoons were a far distant second, and foxes are also possible carriers.
Moving away from rabid bats to the much less scary but much more common problem of cardiovascular disease are findings from a number of important studies.
You don’t need to come back fasting. Traditionally, your blood lipids were always checked after an overnight fast. If you showed up having eaten breakfast, you were asked to come back to have your blood drawn. This requirement has been under question, and a recent study showed that non-fasting lipids were just as reliable a predictor of coronary disease as a fasting sample.
“White coat” hypertension needs to be taken seriously. It has long been known that some people have elevated blood pressure in the doctor’s office but normal BP when checked at home. There has been conflicting advice about whether this was a problem needing treatment. A careful analysis of many studies was published in the Annals of Internal Medicine that showed that people with so-called “white coat” hypertension ARE at increased risk if they are not on BP medication. Those on treatment for HBP who were well-controlled everywhere except in the office did not seem to be at increased risk.
Do you really need the “energy?” So-called energy drinks, which contain large amounts of caffeine among other ingredients, have been linked to increased emergency department visits, and were felt to be the cause of 34 deaths in recent years. About 30% of teenagers and 45% of deployed military personnel consume at least one of these drinks daily. Investigators had young healthy volunteers drink one of two widely sold drinks and monitored their vital signs and ECGs before and after. They reported their findings in the Journal of the American Heart Association. The energy drinks significantly raised pulse and BP in the volunteers and also prolonged the QT interval on the ECG, a change that may make the subjects more likely to have serious rhythm disturbances.
More on how diet affects health. The British Medical Journal reported on findings from the long-running Nurses Health Study. They found that increases in red meat consumption were associated with a higher risk of death, particularly so with processed meat. It is not clear that changing to “white meat” is any better. A study on healthy adults looked at cholesterol on three different diets: beef, chicken and no meat. Plant proteins had by far the most benefit, while chicken and beef were equally bad. Finally, a nutritionist from Tufts, speaking at the annual meeting of the American Society of Nutrition this month, presented evidence that inadequate intake of fruits and vegetables contributed to over 2.5 million excess deaths world-wide. Eat your fruits and veggies, folks!

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Sunday, June 9, 2019

Don't be scammed by stem cells

Earlier in June, the US Food and Drug Administration (FDA) won a major legal victory by getting an injunction to prevent Florida-based US Stem Cell Clinic from offering its treatments. The company claimed to create stem cells from patients’ body fat and use these to treat a variety of serious illnesses, including Parkinson’s Disease, ALS and chronic lung disease. This company is just one of many that have sprung up like weeds offering unproven and generally ineffective treatments to desperate patients.
What are stem cells? Most of the cells in our body have only a single specific job they can do. Heart muscle cells contract and let the heart pump blood around. Bone cells provide the scaffolding that keeps us upright. Red blood cells carry oxygen around our body. None of these can do the job of the other. We do, however, have less-specialized cells that carry the potential to turn into different kinds of cells, and these act as a reserve to repair injury and replace dying cells in many tissues. True “stem cells,” derived from embryos, can become any type of cell, but there are many more partially-developed cells that can turn into some but not all kinds of cells. The best-known are so-called “mesenchymal stem cells,” more properly called mesenchymal stromal cells. These cells reside in the bone marrow, fat, liver and muscle, and can turn into bone, cartilage and fat cells. They are known to contribute to repair of damaged tissues. There is a huge amount of research looking at whether and how these cells can help alleviate human disease. As of last fall, 939 trials were registered with the NIH, the largest number (218) looking at their potential to help neurologic disease. Since mesenchymal stromal cells cannot become nerve cells, it is not certain why they have shown promise in some studies, though one guess is that they donate their mitochondria (the energy producers of the cell) to damaged nerve cells.
Mesenchymal stem cells used in trials have been obtained from bone marrow, fat and umbilical cords. Many of the trials have shown promise, but most have been done in mice, or in a very small number of people. Scientists studying this feel it is a long way before they can be considered as proven useful for humans. This, of course, never stopped a dedicated scam artist. In 2017, there were at least 700 “stem cell clinics” advertising to consumers. They were claiming to be able to cure arthritis, heart and lung disease, erectile dysfunction, Alzheimer’s disease, ALS and macular degeneration, among many other conditions. When asked, the purveyors of these treatments do not point to any trials but to “numerous success stories,” akin to a trip to Lourdes. The most common source of the “stem cells” used in these clinics is birth tissue, usually obtained by mothers who have no idea what their donation will be used for and who are not compensated for their donation. This makes it easier to convince the sufferers than if they had to have needles placed in their bodies to obtain fatty tissue samples or bone marrow cells. It must be noted that when researchers have been able to look at the products sold to the stem cell clinics, none have contained the number of live cells they claimed.
The ”practitioners” at these clinics often blur the distinction between true embryonic stem cells and the mesenchymal cells they use, claiming that their “stem cells” can turn into any tissue needed, which is clearly untrue. Up until recently, there has been little or no oversight of these “clinics” by the FDA, but hopefully that is changing. In the meantime, as your daddy used to say, “if it sounds too good to be true, it probably isn’t.” Save your money.

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Sunday, June 2, 2019

B12 deficiency - the great imitator

Two recent patient experiences prompted this post. In the April 29 edition of the Wall Street Journal, Dana Hawkins-Simons described several years of being seen by specialist after specialist for her complaints of tiredness, dizziness, ringing in the ears, palpitations, shortness of breath and “brain fog.” She finally researched her symptoms and demanded that she be checked for vitamin B12 deficiency, which turned out to be the cause of her symptoms. Last month, the British Medical Journal published the case of a 69-year old woman who was diagnosed with multiple sclerosis based on her rapidly worsening symptoms of hand and leg weakness and numbness, slurred speech, poor concentration and urinary symptoms. At the center where she went for a second opinion, B12 deficiency was suspected and proved to be the cause of her symptoms rather than MS. Fortunately, she had not yet begun on the previously recommended immune-suppressive MS treatment.
Vitamin B12 is critical to many body functions. It is needed to build blood cells, and B12 deficiency was the cause of pernicious anemia, so-called because 100% of sufferers died. Dr. George Minot's discovery of the effectiveness of liver therapy in 1926 saved these people, even though no one was sure why it worked. Another pioneer working at the Boston City Hospital, Dr. Bill Castle, identified Vitamin B12 and allowed B12 injections to take the place of crude liver extracts. The neurologic system also needs B12, and deficiency can lead to many neuropsychiatric symptoms, including numbness of the extremities, an unsteady gait, forgetfulness or even dementia, irritability or depression, vision loss and a shock-like sensation down the spine with neck flexion (that is also seen in MS!). The tongue may be swollen, smooth and tender.
How does one get deficient in B12? The classic cause, commonest in elderly people, particularly those of northern European ancestry, is pernicious anemia, in which the body is unable to absorb B12 due to lack of the protein needed to allow it to pass through the intestine into the body. It was thought that dietary lack was uncommon because B12 is found in so many foods, but these are all of animal origin, and it is easy for strict vegans to become deficient if they do not take supplements. There may be decreased absorption of B12 after gastric bypass surgery or in the setting of gastrointestinal diseases such as celiac or Crohn’s diseases. Some medications, particularly the diabetes treatment metformin or long-term use of acid-suppression, may cause decreased absorption.
If you have any of the symptoms listed above, particularly if you have some the listed risk factors, you should insist on being tested. The level of B12 can be measured in the blood, but there is a wide range of “normal” and many people who are deficient may be in the low normal range. One clue may be found looking at the size of your red blood cells. If you have a patient portal or a print-out of a recent CBC (complete blood count), look for a number described as the MCV. This is short for mean corpuscular volume and describes the size of the red blood cells. Deficiency of B12 (or folic acid) typically leads to larger than normal red cells even before you become anemic. If your B12 level is below 200, you are deficient. If It is 200-300, you may be, even though the lab will list anything above 200 as normal. If your symptoms may suggest deficiency and your blood level is “low normal,” ask for further testing. This is not difficult. Another blood test, for methylmalonic acid (MMA) is almost always elevated with B12 deficiency. Be persistent. Ask to be tested – the testing is neither risky nor terribly expensive – and the consequences of missing B12 deficiency can be severe.

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Sunday, May 26, 2019

The $2 million cure

You can save your baby for $2 million. Can you afford to do this? If you cannot, should we all pay?
Spinal muscular atrophy (SMA) is a rare genetic disease affecting the part of the nervous system that controls voluntary muscle movement. All types of SMA result from a single known cause, a deficiency of a protein called SMN, for "survival of motor neuron." When SMA symptoms are present at birth or by the age of 6 months, the disease is called type 1 SMA (also called Werdnig-Hoffmann disease). Babies with SMA Type 1 typically have generalized muscle weakness, a weak cry and breathing distress. They often have difficulty swallowing and sucking, and don't reach the developmental milestone of being able to sit up unassisted. These babies have two copies of the SMN2 gene, one on each chromosome 5. Over half of all new SMA cases are SMA type 1. It is a horrible disease; untreated, half of all affected infants will not live to one year of age, or if alive will require a ventilator (breathing machine). The disease affects about one in every 10,000 births, so there are about 300-400 babies born each year in the United States with this up-until-now fatal disease.
On May 24, the FDA approved a gene-based therapy for SMA-1 called Zolgensma, developed by a company that was bought by Novartis. The therapy involves injecting affected babies with an adenovirus containing a copy of the correct gene, that is taken up by the babies’ spine and theoretically cures the disease permanently. The trial which led to FDA approval was done on 22 affected babies; it showed that 21 of 22 were alive and reaching expected developmental milestones at 9.5 months of age. Untreated, 50% of these babies would not be expected to be alive at one year. For the parents of these babies, a miracle. The only fly in the ointment was that Novartis announced the treatment would be priced at $2.125 million! The only previously-approved gene therapy for an inherited disease was approved in 2017 for a rare, previously untreatable, eye disorder leading to blindness. This was priced at $425,000 for each eye. These two treatments promise (though long-term results are many years away) to cure a disease. We are now also starting to see new drugs to treat uncommon and hard-to-treat diseases that are not cures but which carry a sky-high price tag. One is Orkambi, used to treat cystic fibrosis, a hereditary disease that is treated much more easily than it used to be, though children with it are still prone to repeated lung infections. This drug clearly improves the course of patients with cystic fibrosis, but modestly, and is priced at $250,000 a year and must be taken indefinitely.
The focus of lawmakers has been, not surprisingly, on common drugs that are seeing steady price rises well above inflation, and which are taken by millions of people. Insulin is the classic example. Its price has resulted in diabetics skipping their doses and getting sicker or even dying, and this for a drug that has been in use since 1922. While pharmaceutical companies have tweaked the molecule, there have been no breakthroughs. I believe that there is enough outrage that Washington will convince or force the pharmaceutical industry to at least moderate their price increases.
What we have not yet come to grips with is how to deal with the astronomical prices of the new “breakthrough” drugs such as Zolgensma. It is hard to see a health insurer refusing to pay for a truly life saving drug. Among the many problems to be faced are how an insurance company deals with the fact that they may be paying for a drug for a patient who will not be even in their plan next year; is it fair to them? What happens if the miracle loses its luster a few years down the road. The results for Zolgensma are after less than a year of use. What happens if the effect wears off? Does Novartis have to refund some or all of the money? If we treat 350 babies a year, we are talking $700 million/year – and the U.S. already spends too much on health care. Does that money come at the price of bridges falling down? Since many of these new gene-based therapies grew out of public (NIH) funded research, it is reasonable for our elected representatives to negotiate a “fair” price that takes this into account and does not simply allow big pharma to enrich its executives and shareholders.
You remember that old Chinese curse: “may you live in interesting times.” Well, hold onto your hats. The next few years will be very interesting.

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Sunday, May 19, 2019

Baby, its later than you think

A recent New York Times Op-Ed piece had the catchy title “Don’t see your doctor in the afternoon.” It was prompted by a study published in JAMA Network Open that had the much less catchy title “Association of Primary Care Clinic Appointment Time with Clinician Ordering and Patient Completion of Breast and Colorectal Cancer Screening.” The study found that the frequency of appropriate ordering of mammograms was highest (64%) for patients with 8 AM appointments and lowest (48%) for those seen at 5 PM. Similar results were seen for colorectal cancer screening, (36.5% at 8 AM and 23.4% at 5 PM). [Why so much lower for colon cancer screening is a subject for another day.] Patients did not follow through with all the recommended testing, but the trend was the same, with more patients completing the recommended tests if they had early morning appointments.
Why is this? Part of it is simple fatigue as the day goes on. Similar results were found when the National Highway Safety Administration looked at when most fatal traffic accidents occur. The evening, but not the morning, rush hour saw the greatest number of fatal accidents. Decision fatigue is used at car dealerships, where the most expensive and unnecessary options tend to be given at the end of a series of choices. Doctors, believe it or not, are human. We get tired as the day goes on, and fatigue clearly has a negative effect on decision-making. There is also the factor that primary care doctors these days have impossible workloads, with more things to be crammed into a 10-15-minute visit than can possibly be done, and the ever-lurking electronic record and its insatiable demands for data making things worse. We know that talking someone into a screening test takes time, and it is much easier to do this before we are already half an hour behind schedule.
While not recommending a screening test can be made up at a later visit, I strongly suspect that other forms of decision-making also suffer as the day goes on. It is much easier to prescribe an antibiotic that we know is not needed than to explain why the patient would be much better without it. I don’t have the data, but I would be willing to wager that more diagnostic errors are made on the last patients of the day than the first.
What can be done? Ideally, doctors would have more time for a visit and not be so rushed. In the real world, when you are scheduling your next visit, try hard to make it early in the day, before your doctor is too tired to think optimally.

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Monday, May 13, 2019

Doctor - could I have Alzheimer's disease?

As my patients aged along with me, I noticed both the expected increased numbers of people with some form of dementia and even more patients who were worried about this topic. Unless you have been away on a ten-year safari, you are very aware that dementia is a growing problem. Some 5.8 million Americans are living with Alzheimer’s Disease, and similar numbers occur in most western countries. The incidence goes up with age, and we are living longer. As I responded to a questioner recently, the only way I know of to avoid getting the disease is to die young (which I don’t recommend as a preventive strategy).
The subject gets complicated because normal aging is often accompanied by some mild memory loss. A not-unfamiliar dialog between a couple in their 70’s might be: “I was thinking we might watch a movie – the one with that actress we both like.” ”The one that starts with M?” “Yes, Meryl.” Which movie?” “Oh, the one we thought was out of her usual.” “You mean that comedy?” “Yes, about a wedding.” “OK – the Abba musical.” “That’s the one!” Mild changes in memory or less ability to quickly learn new facts are both common as we age and do not usually interfere with functioning.
There is also a condition called “mild cognitive impairment” (MCI) in which the changes in thinking and memory are more than one would expect with normal aging but not severe enough to be called dementia. The latter usually includes both memory loss and some other symptoms such as trouble with word-finding, getting lost in familiar places, inability to cope with unexpected events or handling complex tasks. Some, but by no means all, people with MCI will go on to dementia and doctors really cannot predict which will.
If a person appears to have dementia, the task of the primary care physician, often with the help of a neurologist, is to decide what is causing the dementia. While Alzheimer’s Disease is the most common, there are a variety of other brain diseases that can cause dementia. While there are some clues to be gotten from detailed brain imaging, particularly the PET scan, Alzheimer’s is in essence a clinical diagnosis, as there are no blood tests that can be used. It is important to not overlook the treatable causes of dementia. Depression can cause a “pseudo-dementia,” and a variety of medications can do this, including many that are used by the elderly. Both B12 deficiency and an underactive thyroid can cause dementia; while infrequent, testing for these is easy and reliable and should always be done once.
To complicate matters, a group of neurologists specializing in dementia have recently proposed that, particularly in the oldest group, over 80, a newly described condition they call LATE, for “limbic-predominant age-related TDP-43 encephalopathy,” may be even more common than Alzheimer’s and may co-exist with it. Their main reason for bringing this to doctors’ attention is that this condition does not respond to the medications used now to slow the progression of Alzheimer’s. The main reason in general to try to make a specific diagnosis is to guide treatment. There are no cures for Alzheimer’s or most of the other dementing illnesses. The medications we have are modestly useful in slowing the inevitable progression of the disease, but that is all they do.
Can you ward off Alzheimer’s without dying young? About all we know is that regular exercise does lower the incidence of dementia, and that a healthy plant-based diet also has modest protective effect. Keeping the brain busy by learning new things is also probably helpful.
So, if your only problem is occasionally forgetting where you left the keys but do find them, you can relax. You probably do not have Alzheimer’s. Get out there and exercise, eat healthy and learn a new language.

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Saturday, May 4, 2019

Who is to do the rationing?

One of the arguments made against adopting single-payer health care in this country is that it would “lead to rationing.” This assumes that we lucky people in the US have unlimited access to whatever health care we need and are at risk of losing it. This argument came to mind when I saw a few recent news items. One was that a federal judge, US District Judge Robert Scola, recused himself from a case in which a cancer patient was suing United Healthcare for their refusal to cover the recommended proton beam therapy for his prostate cancer. Judge Scola said he could not rule on the case impartially because he himself had been treated for prostate cancer and had been offered proton beam therapy (though he ultimately chose surgery). In his order of recusal, he wrote “To deny a patient this treatment, if it is available, is immoral and barbaric.” Saturday’s Boston Globe featured an article about a young woman with advanced cancer of the cervix who was referred to Mass General Hospital for proton beam therapy whose insurer refused to pay for the treatment despite multiple appeals.
Moving from anecdotes to a larger sample (and I am well aware that the plural of anecdote is not data), I found a survey conducted among radiation oncologists this Spring. Nine out of ten said their patients faced delays in getting recommended therapy for their cancers. Almost a third (31%) said that such delays lasted more than five days, the equivalent of a standard week of therapy. The reason that this is important is that for every week therapy is delayed, there is about a 2% increase in mortality. Almost two thirds (62%) said that the denials were ultimately overturned on appeal, making one wonder why the therapy was denied in the first place. Having been harassed for years by insurance company clerks over getting approval for tests and treatments, I have my own theory, which is that the insurer hopes that blanket denials will weed out many expenses, as the doctor will be too busy or frustrated to spend the time to appeal, thus saving the insurer money. As I note in Prescription for Bankruptcy, an AMA survey in 2018 of 1,000 physicians found that 92 percent felt that prior authorization programs delay access to care, with 78 percent saying that prior authorization causes some patients to abandon recommended tests or treatments. Maddeningly, 30 percent said they had waited three or more days to get a decision from the insurance company. The radiation therapists noted that when their appeals reached the point of speaking to a “peer,” the physician with whom they spoke was almost never in that field and often demonstrated little knowledge of the problem being addressed. Put this together with Aetna’s recent settlement of a lawsuit alleging that their physician reviewers rarely even read the patients’ records before issuing denials, and one sees a pattern. While there is room for legitimate disagreement about the value of some therapies, it is inappropriate for the insurer, with a clear financial stake in the decision, to be the decision-maker about what tests and therapies are covered. In any rational health care system, the determination about paying for a procedure would be made by disinterested experts who could look at the scientific evidence and make a recommendation with no financial stake in the outcome.
Rationing? We have rationing now, but the rationing is done by those who save money from doing this. In my ideal system, patients, clinicians and statisticians would make evidence-informed guidelines. In the absence of such a rational process, I would rather this be done by “bureaucrats” than by the for-profit insurers as it is now.

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Saturday, April 27, 2019

Is anyone healthy?

A wag once said: “There is no such thing as a healthy person, just one who has not had enough tests.” As we make every minor deviation from the average into a disease, that jest is becoming uncomfortably close to the way our current medical system behaves.
Part of the problem is that many “diseases” represent an arbitrary cut-off of a number. Thus “hypertension” is defined as a blood pressure above a specific threshold. We all have blood pressures, and these pressures vary from minute to minute. Clearly everyone with any medical background would accept that a BP of 220/150 was a very bad thing and should be treated. But how about 142/90? To demonstrate how arbitrary any number is, consider that the diagnosis of hypertension starts at 140/90 according to the European Guidelines, and 130/80 according to the US Guidelines. The US definition was recently changed to a lower cut-off, overnight classifying tens of millions of people as having a disease. Using this definition, almost half of all adults would now carry a diagnosis of hypertension.
Before the discovery of insulin, pregnant women with diabetes all died. Once insulin was introduced, diabetes became a treatable condition, and doctors went looking for it. Since blood sugars also range widely, and reflect when and what we last ate, arbitrary thresholds were set to define gestational diabetes, or diabetes developing during pregnancy. The numbers used were changed in 2008, not because of new knowledge but by consensus among experts. As is virtually always the case, the numbers were set to label many more women as having the disease – and therefore creating many more customers for the physicians treating them and the pharmaceutical industry.
Then there are “diseases” that are only laboratory numbers. Thus “chronic kidney disease” is defined by a serum creatinine above an arbitrary number. The number picked does not take into account that kidney function slowly deteriorates with normal aging. Almost half of older adults are thus labelled as having chronic kidney disease even though most of them will never have any symptoms from their kidneys in their lifetime nor benefit from any treatment.
Proponents of these expanded definitions may well have the best of intentions, but over-diagnosis is not harmless. In many cases, people newly labelled with a disease are put on medications that are of minimal benefit and may do harm. They may become uninsurable or may have to pay higher premiums for life and health insurance.
The “expert panels” that promulgate these definitions almost invariably make changes that expand the pool of patients. They rarely look at the downside of over-treatment, and they tend to be dominated by academics with multiple financial ties to the pharmaceutical industry.
Your best defense against being labelled with one of these “diseases by definition” is to suggest that your doctor give you 6 to 12 months of lifestyle changes before giving you either a label or medication. Perhaps the desire to escape being labelled as hypertensive or pre-diabetic may be just what you need to motivate you to lose that 10 pounds you have always said you would and to start walking at lunch time.

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Saturday, April 20, 2019

So, you are going to "rehab"

This is the scenario. You (or your mother) were admitted to the hospital with pneumonia. On the third day a cheery continuing care nurse comes in and says “you don’t have a fever any more and the doctors feel you can be discharged to finish your course of antibiotics but your nurse tells me you are still too weak to go home, so we are going to send you to rehab. Here are three facilities that have a bed for tomorrow. Why don’t you discuss this with your family and tell me which one you prefer.” This happens dozens of times a day in every community.
Several issues immediately arise. The first is that when you ask the continuing care nurse which is best, she tells you she is not allowed to make a recommendation. Another is whether this transfer is really necessary or whether another day or two in hospital would allow you to go home instead. If a rehab stay is necessary, how do you decide on a facility with very little time to research your options?
Remember that hospitals are paid by Medicare based on the admitting diagnosis, not on how long you are hospitalized. For pneumonia, the hospital will get the same payment if you are out in 2 days or spend two weeks. This means that the incentive is to get you discharged ASAP. If you feel you are almost ready to go home, dig in your heels and say you want to stay another day and then go home; they won’t like it, but will usually agree.
Also, critically: Medicare will pay for a rehab stay only if you are admitted to hospital and spend three nights. “Observation” days do not count. As the patient, you have no way to tell an official admission from an observation stay – same room, same bed, same nurses most of the time. ASK!
Most hospitals will not make recommendations about facilities. Hospitals say their reluctance is due to fear about violating a government decree that hospitals may not "specify or otherwise limit" a patient's choice of facilities. But that rule does not prohibit hospitals from sharing information about quality, and a handful of health systems, such as Partners HealthCare in Massachusetts, have created networks of preferred, higher-quality nursing homes while still giving patients all alternatives. Most hospitals simply dump the choice in the lap of the patient and family.
One easy way to get a “first pass” screen of nursing homes is to use the Medicare web site. Go to https://www.medicare.gov/nursinghomecompare/search.html and enter your zip code. You will see a list of all Medicare-certified nursing homes and their ratings across the results of state health inspections, staffing ratios and “quality measures.” These are listed by distance from the zip code given. Staffing ratios are obvious: the more nurses, aides and therapists per resident the better. The quality measures include such things as how often residents were successfully discharged to community setting, how often they had unplanned ED visits or readmission to hospital, how often antipsychotic medications were started and others.
This information will let you immediately eliminate the poorly-rated nursing homes – and if all the ones on the list with openings are one or two-star (out of five), I would refuse all of them. If one or more are four or five-star, you are probably safe. The next step is to have a friend or family member visit and get a gut feeling. Do not be over-impressed with the newness of a facility or the paintings on the wall. You are, hopefully, not going to be there long, nor is this a hotel. What is crucial to a good recovery is the staff. Look around. Are most of the residents restrained in chairs? Visit the PT department. Ask residents about the food and about how quickly call bells are answered. If the staff seem defensive and uncomfortable answering such questions, this is probably not the facility to choose.
Once you are at a rehab facility, the more family involvement the better. It is human nature for the staff to pay more attention if they know concerned family and friends are around a lot. They are also the best ones to notice if things are not going well and seek remedies. Be sure to eat even if the food is not home cooking: you cannot recover without adequate nourishment. Even if you would rather rest, do your physical therapy. Remember, the more work you put in, the sooner you get out of there.

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Saturday, April 13, 2019

When is a check-up not a check-up?

Kaiser Health News told the story of a 69 year old woman who went to a new doctor for her annual check-up, assuming it was covered by Medicare, and was happy with the visit until she got a $400 bill.
Most Americans believe in “annual check-ups,” at which your doctor reviews your medical history, gives you a thorough physical and orders lab tests. The actual value of such visits has been questioned, but they are ingrained in our psyche. Such “well visits” are helpful for children, where preventive care, including counselling and immunizations, adds value. It is not of nearly as much value in adults, and the vaunted “executive physical,” with its extensive battery of tests has been largely discarded. Yet, most of us still have gotten used to seeing our doctor once a year even if we are feeling fine.
When Medicare was first established, it was specifically geared to treating illness, and preventive care was excluded from coverage. Over the years a variety of preventive measures have been added as covered services, including screening tests and immunizations. A full list of these can be found at https://www.medicare.gov/coverage/preventive-screening-services. The newest addition to this list is the “Annual wellness visit,” which is fully covered under Part B. For those who are used to seeing their doctor for an annual check-up, this sure sounds like the same thing, and it does to many doctors as well. Unfortunately, if your doctor conducts this visit in the same way, with a review of your history, a physical and lab tests, you are likely to get an unexpected bill.
The Medicare Annual Wellness Visit is a very limited and specifically described set of services. At this visit your height, weight and blood pressure are to be measured, but no other physical exam is to be performed. The doctor is supposed to assess your risk of falling, your ability to bath and dress yourself and whether you are safe at home. You are to be screened for depression and dementia. Medications should be reviewed. A schedule of preventive services should be provided. If you have seen this doctor regularly, these may sound like a waste of time, and they may well be. I rarely did such visits. If at his last visit a patient had told me he had chopped too much wood and was willing to sell me a cord cheap, I would have felt like an idiot “assessing his fall risk.” What the doctor cannot do at such exams is check your blood pressure, tell you it is a bit higher than ideal and adjust your medication; if he or she does this, it is outside the parameters of the Wellness Visit and not covered. Because of the limited nature of the visit, over half of medical practices surveyed a few years ago did not offer these visits, and only 19% of Medicare beneficiaries received one.
What makes it even more confusing is that some (but not all!) Medicare Advantage plans WILL cover an old-style Annual Check-up.
So, bottom line: if you have standard Medicare, do not schedule an “annual physical” unless you are prepared to pay for it. Assuming you, like most of us over 65, have some chronic conditions being monitored, you should be able to get a longer visit at which all of these are addressed and the doctor has enough time to throw in a little more preventive care.

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Monday, March 25, 2019

My last doctor said I had lupus!

During my time in practice, I had at least eight patients who came to me sure they had systemic lupus erythematosus, also commonly called SLE or lupus. This is an “autoimmune disease,” characterized by joint pain, that can affect almost any organ, including skin, kidneys, brain and heart, and can even be fatal. In every case, they had been given this diagnosis because of a blood test called an ANA, for anti-nuclear antibody. Not one of these women (they were all women) actually had lupus. Why then were they told they did?
All of us, doctors and patients, tend to have too much faith in tests. When something is written on paper with a decimal point, it must be true, right? What is hard to accept is that just as a patient’s story may change with retelling, or a doctor may not hear a murmur they did hear previously, lab tests are far from perfect. If your serum sodium was 137 last time and is 144 this time is that different? Quite possibly not. Plus/minus 3-4 % is normal variation; even if you took a tube of blood and split it in two and sent the samples labelled Smith and Jones, they would be unlikely to have identical results.
Many tests do not have numeric results but are “positive or negative” or “normal or abnormal,” and here is where it gets complicated. Essentially every such test used in medicine, whether it is a strep screen or a cardiac stress test, has false positives and false negatives. That is, you are fine but your test is not (false positive), or you are sick but your test is fine (false negative). A test for which 90% of sick people had an abnormal result and 90% of well people had normal results would be considered a very good test. Thus, any test must be interpreted in the context of the person on whom it is done. If you are a middle-aged smoker with high cholesterol and you have been having chest pain when you take out the trash, then a positive stress test helps to confirm that you have coronary disease. If you are a fit 30-year-old woman whose family all lived to 90 and have a stress test as part of an executive physical, a positive test is most likely to be erroneous, a “false positive.”
So, let’s get back to my patients who were told they had lupus. The most widely used screening test for lupus is the ANA. It is a very useful test, because 99% of people with lupus have a positive ANA, so a negative test makes it very unlikely the person has the disease. The problem is that about 30% of healthy people also have a positive test. There are ways of making the test better, but these are often not done by non-specialists. So, indulge me in some simple math. Lupus is not a common disease, but neither is it really rare. About 1 of every 200 people going to a doctor for joint pain have lupus. As noted, about 30% of all people, sick or well, have a positive ANA. So, if you do an ANA test on all 200, the one who has lupus will have a positive test, and so will 60 people who do not. This means that 60/61, or 98%, of the positive tests will be false positives. If the doctor does not take this into account, it is easy to tell someone that their test says they have lupus as the cause of their joint pain, when they actually have something else and a false positive test.
The bottom line: do not take medical tests as gospel. If you get a new diagnosis, question it. If you are not entirely satisfied with the explanation, consider a second opinion.

Prescription for Bankruptcy. Buy the book on Amazon

Tuesday, March 19, 2019

Will an Apple watch really save your life?

Last year, Apple’s Tim Cook shared widely the story of an 18-year-old Florida girl who claimed that her watch saved her life by alerting her that her pulse was 190, prompting her to go the hospital for evaluation. She was found to have kidney damage of which she was unaware and referred for treatment. My problem with that heart-warming story was that it was hard to believe she was not aware of that rapid a pulse on her own, and that it may have had nothing to do with her kidneys. This week we have been bombarded with news from a study reported at the Annual Meeting of the American College of Cardiology about the watch’s ability to detect previously unknown atrial fibrillation and thereby “save countless lives.”
First, a brief word about atrial fibrillation (AF). AF is a very common heart rhythm disorder that gets much more common with age. While rare in people under 50, it may affect as many as 10% of those over 75. Most people with AF are very aware of the condition because the heart beats very fast as well as erratically. A few have no symptoms, particularly if they are on a medicine for some other reason that slows the rate. AF can be associated with heart failure and, most ominously, it is associated with a greatly increased rate of stroke. The accepted wisdom is that most patients with AF should be on blood thinning drugs to prevent stroke except for the minority who have absolutely no other stroke risk factors beyond the AF.
The study looked at the ability of the watch to use an app to detect AF. Over 400,000 people self-enrolled on an invitation they got when they down-loaded the Heart Study app. A pulse notification was received by 2161 (0.5%) participants. Not surprisingly, notification was highest in those over 65 (3%) and lowest among those under 40 (0.2%). ECG patches were sent to 658 participants and returned by 450. AF was identified in 34% of those who were notified and wore the patch.
So, a few conclusions can be made. First, the watch can pick up some cases of AF. Second, it has many “false positives:” people who did not have AF despite what the watch said. A huge problem is that the study was not designed to detect “false negatives:” we have absolutely no idea how many of the participants did have AF that was not detected by the watch because no one got a patch who did not receive an AF alert. Since Apple watch wearers tend to be younger and healthier than non-wearers, many of the alarms are likely to be false positives, thereby causing anxiety and unwarranted health expenditures to evaluate the alarms.
Another problem with the study is that we really have no idea whether treating younger people who do truly have AF detected by the watch will help or harm them. The evidence that using blood thinners prevents strokes was all obtained back in the 1990s and came from people who had symptomatic AF. These drugs have enormous potential for harm from bleeding, and it is very possible that treating people found via apps may do more harm than good.
So, take the hype with a grain of salt. Enjoy your watch but do not depend on it to save your life.

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Monday, March 11, 2019

Surprise!

Case 1: On March 1, ABC News reported the story of a Florida woman bitten by a stray cat she was trying to help. Having heard about rabies in stray animals, she went to the closest emergency room, where she got her first rabies vaccine and was also given an injection of rabies immune globulin, designed to protect the victim before the vaccine takes hold. She also later got a bill for $48,512, of which $46,422 was for the immune globulin. The product is not in particularly short supply and is available from three manufacturers and the average price paid by hospitals for the dose she got would been about $4334.
Case 2: A posting on Kaiser Health News back in November epitomized much of what is wrong with health care in today's America. An English professor in the California state university system went to Stanford University's outpatient clinic for help with a rash that she thought might be due to a cream she had been prescribed. She had 119 tiny plastic containers taped to her back and ultimately learned that she was allergic to a variety of things, including the ingredient in her cream. All well and good until she saw that Stanford had billed her insurance company for $48,329! This included $848 for the time she spent with the doctor and $399 for each of the 119 small samples taped to her skin. The "usual and customary" charge in the San Francisco Bay area for this is $35 per sample.
Case 3: There is also the story I recount in Prescription for Bankruptcy about a man who was mugged and taken to the emergency department for attention. He was aware (and concerned) enough to check before being transported that the hospital to which he was taken was “in network” for his insurance. He had suffered a broken jaw and was taken to the operating room for repair. Weeks later he got very large bills from the oral surgeon and anesthesiologist who cared for him who were not in his insurer’s network.
These three cases cover most of the causes for surprise medical bills. The Florida cat lover was at the mercy of price-gouging by the hospital she went to for help. The California professor and her insurance paid astronomical prices to the prestigious hospital system that knows it can overcharge because they are in the driver’s seat. It is hard to sell a health insurance package in northern California that does not include the perceived leading hospital in the area. The mugging victim was victimized a second time because even when a hospital has signed a contract with a health insurance company, many of its doctors may not. This practice is particularly common among specialties where the patient does not really have much choice in who sees them: emergency physicians, radiologists, pathologists and anesthesiologists.
Hospitals are now required to post their charges on-line, but to date they have (probably deliberately) done so in the most abstruse manner possible, using obscure terms that most non-medical people find hard to read or search. Hopefully some clever people will soon come up with an app to make the search more user-friendly.
What can you do about these nasty surprises? For diseases – like rabies – with obvious public health importance, you may be able to get treated at your local public health department for free. DO NOT POSTPONE TREATMENT to save money. If your problem occurs on a Saturday, go to the ED.
You must get in the habit of asking the doctors assigned to you if they take your insurance. Do not assume that they do because they are affiliated with a hospital that does. If you get an obviously-inflated charge compared to what others charge, you are entitled to, and should ask for, an itemized bill to see why the total is so high. First take your complaint to the hospital administration and offer to pay a more comparable charge. If that is rejected, and you have employer-paid insurance, take the bill to your HR department and ask them to intercede. If that does get an acceptable result, go to your local newspaper or television station. It gives them material for a human-interest story and just may get the hospital to offer a lower charge. Use social media to try to shame the over-charger.

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Thursday, March 7, 2019

Do I really need all these pills?

My last post discussed the importance of taking medication as prescribed, focusing on medications that were intended to prevent things like strokes, heart attacks and fractured hips. There is another side to the coin. Doctors are increasingly aware of the problem of “polypharmacy:” taking a lot of pills. Almost 60% of all Americans take at least one prescription medicine and a third of Americans over 65 take five or more medications daily. Add to these various supplements and over-the-counter (OTC) pills and that can add up to quite a handful. At times this may be appropriate and beneficial. If you have diabetes, hypertension and congestive heart failure, most of your pills may be needed. However, in many cases pills have been added by one doctor unaware of what another doctor prescribed. Your primary care doctor (if you are fortunate enough to have one) may not even be aware of everything you are taking. Many medications interact in ways that may be harmful. Some may have been intended only for short-term use but were never stopped. Some may have been appropriate when you were younger but have more side effects as you age.
Some specifics: many drugs to treat bladder problems cause dry mouth in everyone but also constipation, confusion and falls in the elderly. Young patients with diabetes with good home support benefit from having their blood sugar tightly controlled; it prevents later eye, kidney and vascular problems. Older patients benefit less and are much more at risk of low blood sugar (hypoglycemia) which can be a serious threat, even fatal, if they are over-medicated. Some patients whose blood pressure has been well-controlled can lower or stop their medications and maintain good pressure for extended periods or indefinitely. Anti-anxiety medications and many sleeping pills have been repeatedly linked to falls in older patients who take them. Digoxin has been used for a century to treat heart failure but more recently has been found to increase death rates in people who take just a bit too much.
What can you do? First, be sure to carry with you a list of every pill you are taking. This may be life-saving should you end up in an emergency department, but it should also be shown to any doctor you see. Periodically it is useful to ask your primary care doctor to review what each of the pills is for, and to ask whether there are any that might be safely stopped. I would always ask my patients once a year to make a “brown bag visit,” bringing in every pill they had at home and we would often be able to cull many that were duplicating each other. It was amazing to find that people were often taking the same medication twice, because the pills in the different bottles looked different because of different manufacturers and may have even had different names – one branded, one generic. It may be appropriate to ask if lifestyle changes could take the place of some of your pills. If you are willing to put in the effort, this is often possible. The same review may be able to identify expensive pills that have an equally good and cheaper alternative.

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Monday, March 4, 2019

Yes, you DO need to take that pill

Over the past 60 years we have come a long way in treating many conditions in ways that prolong life and health. Perhaps this is best exemplified by the approach to high blood pressure (“hypertension” or HTN). History buffs may be aware that Franklin Delano Roosevelt died of complications of HTN. In 1937, when FDR was 54, he had a BP reading of 162/98, but the prevailing medical opinion at the time, espoused by such eminent men as Paul Dudley White, was that HTN should be considered necessary and not be treated. Even had his physicians wanted to lower FDR’s blood pressure, there were no effective ways to do so at the time. As was the rule in those days, his BP rose inexorably and he subsequently developed heart failure and had a series of small strokes, and finally died of a massive brain hemorrhage.
Life insurance companies were aware as early as the 1950s that people with HTN died prematurely and refused to insure them, and the medical profession belatedly began to connect untreated HTN with heart and kidney failure and stroke, and effective medicines to lower blood pressure became available. Since the 1950’s there has been a dramatic reduction in HTN-related illness and death.
Another area where preventive medicine has made enormous strides is in lowering cholesterol and preventing coronary artery disease. Added to this has been the drop in the number of people who smoke, another major factor in causing heart attacks. When I was an intern and coronary bypass surgery was in its infancy, the recipient of successful coronary grafts was often told “see you again in 10 years,” as little was done to modify the factors that had brought them to the catheterization lab and surgery. Nowadays, with aggressive risk factor control, the CABG patient may be good for 20 years or more.
Osteoporosis is another condition that now has multiple available treatments that have been shown to reduce fractures that add to disability and death.
The common thread among all these conditions is that the medicine must be taken to work! About 70% of Americans have been prescribed a medication for chronic use and more than half take two or more. Despite the overwhelming evidence that these medicines, when properly prescribed and regularly taken, extend life and prevent disability, nearly half of us do not take our medications as prescribed. Surveys show that half of us missed at least one dose, one in three could not remember if they had taken a medication and 25% did not refill a prescription when it ran out. Even participants in clinical trials, who are followed much more closely than are patients under routine care, often stop taking the study drug.
The reasons people do not take medications as prescribed fall into several categories. The most obvious potential cause, cost, is one of the less common reasons given. For any individual patient cost can be a huge factor, but cost is only cited as the reason for non-compliance by about 16%. A similar number stop because they are concerned about side effects or by something they have read (often on the internet!). Many people stop taking their medication because they do not feel any better and do not feel it is worth the bother. This is certainly true for HTN, osteoporosis or high cholesterol, which are symptom-less conditions until they are far advanced. The commonest reason of all is simple inattention, forgetfulness.
Non-compliance, according to estimates in a study published in the Annals of Internal Medicine in 2012, may add $100 billion to our national health bill due to preventable hospitalizations as well as many premature deaths. The most recent data shows that patients with coronary disease who were less than 50% adherent with their "statin" had a substantially (30%) higher death rate than those who were more than 90% adherent.
What can you do? First, if your doctor prescribes a new medication, be sure to ask why it has been prescribed, what you should expect to see, good or bad, and if there are alternatives should it not agree with you. Ask what to do if you forget a dose: should you double up or just get back on schedule? If you get sticker shock when you go to the pharmacy, refuse the medicine. Once you have walked out with it, they cannot take it back, but either you or the pharmacist can call your doctor and ask if a less expensive alternative would work. If you experience what may be side effects, do not simply stop but call your doctor and discuss these. Do NOT take frightening tales you read on social media as the truth and discuss these with your doctor or pharmacist before acting on them.
Finally, make it easy for yourself. Put the pill bottle out where you can see it – that may be on the bathroom shelf or the kitchen table, but it should not be in a cabinet or drawer. If you are taking several pills, particularly if they are taken at different times, use a pill organizer which you can fill once a week and then leave it out in an obvious place. (And ask your doctor if a simpler schedule would work as well!)

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Wednesday, February 27, 2019

Doctor, would you mind washing your hands?

Last year was the bicentennial of the birth of Ignaz Semmelweis (1818-1865), a Hungarian obstetrician who saved the lives of thousands of mothers. In the 1800s, "childbed fever" was rampant in maternity hospitals throughout Europe, and about 10% of new mothers died of this poorly understood condition. There were many theories, some quite outlandish, about the cause. In 1846 Semmelweis became the chief of obstetrics at a Vienna hospital. He was able to connect the facts that the rate of childbed fever was much less in a neighboring hospital where midwives did the deliveries than at the hospital where doctors did the deliveries and that the doctors (but not the midwives) attended autopsies before doing their rounds. He figured out that something was carried on the hands of the doctors from the autopsy room, though this was before anyone knew about bacteria and he called the culprit “decomposing animal material.” He began insisting that the doctors at his hospital wash their hands with a chlorine solution after leaving the autopsy room and before examining mothers in labor. The rates of fever and death dramatically dropped after he began this practice. It was a long time before his theory and practice was widely adopted, and only after his untimely early death was his work given the recognition it deserved.
Why is this history lesson relevant to us? In 2019, with all our understanding about infections and how they are spread, about 7% of hospital patients develop an infection while in the hospital, so-called nosocomial infections. In the intensive care unit, this may reach as high as 50%! Most of these infections are still carried on the hands of doctors and nurses from one patient to another. Study after study has shown that less than half of doctors carefully wash their hands between examining patients despite multiple interventions designed to increase this behavior. The introduction of alcohol-based water-less hand washing antiseptic solutions has made the process faster and easier, but even so only a minority routinely use this between seeing every patient. I was able to find at least twenty studies of methods that were used to try to get more health care workers to follow this simple life-saving practice. Most showed at least some improvement, but still rarely achieved compliance much above 50%.
Infections caught in the hospital tend to be nasty ones: MRSA (resistant staph infections), other bacteria that are resistant to most antibiotics, C-diff causing horrible colitis, etc.
So, take matters into your own hands! If you are a patient in the hospital, when a nurse or doctor comes to see you, be obnoxious. I would suggest something on the lines of “Dr. X/Ms. Y, I am really paranoid about getting an infection. Can I ask you to wash your hands before you examine me?” Better to be thought a difficult patient than a sick one.

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Sunday, February 24, 2019

But it was just an over-the-counter pill!

We all get various aches and pains, whether they be headaches, joint pain, backaches or the generalized achiness that goes with many viral illnesses. When we do, we typically reach for something to relieve the pain. These days we are all-too-aware of the problems with narcotics, the most potent pain relievers, and doctors are much more reluctant to prescribe them. There are a lot of non-narcotic alternatives, most of which can be bought off the drugstore shelves without a prescription. Most of these are safe when used in low doses for a short time, but they are not “safe” in the sense that they can be taken at will.
Most non-prescription pain relievers are NSAIDs, non-steroidal anti-inflammatory drugs. These relieve pain by reducing inflammation. The class includes many prescription medications and two widely-available drugs, ibuprofen (Motrin) and naproxen (Aleve). The grand-daddy of all NSAIDs, of course, is aspirin. The most common pain reliever that is not an NSAID is acetaminophen (Tylenol).
NSAIDs reduce inflammation by inhibiting the body’s production of the hormone prostaglandin. While this has the good effect of reducing pain and inflammation, prostaglandin has many other roles in the body. Notably, it protects the stomach by building up the lining, and it helps regulate blood flow to the kidney. Hence, taking large doses of NSAIDs for an extended period can lead to gastritis or ulcers and can result in serious stomach bleeding. This is often made worse because aspirin and all NSAIDs decrease the ability of platelets to stick together and stop bleeding. Particularly in older patients or those with reduced kidney function, but possible in any person, NSAIDs can cause worsening kidney function, which can become permanent if not caught early. A just-published study of young healthy adults (U.S. soldiers) found that even among these low-risk folks, regular use of NSAIDs was linked to acute and chronic kidney disease. Because of their effect on platelets, NSAIDs are particularly hazardous to patients taking blood thinners.
OK, then, I guess it is acetaminophen, right? Used properly, acetaminophen is remarkably free of side effects. However, when used too much, it has its own problem: liver damage. The recommended safe dose of acetaminophen is 3 grams (3000 mg) per day in healthy people. This is the amount found in six “Extra strength Tylenol.” When healthy volunteers took 4 grams/day for a week, three quarters (76%) developed at least mild elevations of their liver tests. Single doses of over 7.5 grams (usually over 15 grams) can cause severe damage to the liver, often irreversible, and acetaminophen overdose is the commonest cause of severe acute liver failure. A key consideration is that acetaminophen is found in many prescription (Percocet, Vicodin, Fioricet) and non-prescription (Tylenol-PM, Actifed, etc.) medications, so be sure to read the label of any pills you are taking. Another important warning is that if you drink alcohol, this is already adversely affecting your liver, so it will be more sensitive to the effects of acetaminophen.
What is one to do? First, the safest option for pain is often non-medication: ice, heat, stretches, massage. If these do not work, acetaminophen in safe doses is the next to try. If you are young and otherwise healthy, up to 3 grams/day. If you drink, keep it to 2 grams/day. Be sure you are not already getting some in other pills you are taking.
If acetaminophen does not work, and it often does not for joint pain, then ibuprofen or naproxen are the next step. This are very similar in effectiveness, though some people get better relief from one than the other. The major difference is in how long they work; ibuprofen typically works for 4 to 6 hours, while naproxen works for 8-12 hours. If you can get by with taking these in the label-recommended dose for a few days, they are generally safe. If you need to take them for a long time, ask your doctor about the need to have your kidney function monitored and/or the advisability of taking medication to protect your stomach.
And remember to try non-medication approaches along with any pills you take!

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Thursday, February 21, 2019

Should you get a shingles shot?

If you had chicken pox as a child, you are at risk of getting shingles.
Most of us old enough to drive had the chicken pox when we were children. A vaccine was first licensed in the U.S. in 1995 and the number of cases of chicken pox peaked in the early 2000’s and have declined steadily since. For most kids, chicken pox was a mild illness, and when I was a child we would have “chicken pox parties” when a case appeared in our neighborhood to get it over with. The virus, however, is sneaky. After recovery, the virus would often go into a dormant resting phase, living in nerve roots near the spine. Our immune system generally kept it from reactivating. As we age, our immune system becomes less robust and can let the virus emerge from its resting phase. Because the virus’s home is at the root of the nerve, it spreads along the course of the nerve. When it does so, we experience pain along the nerve, then a red rash and finally blisters that often form ulcers and eventually heal. This is what we call shingles, known medically as herpes zoster. Shingles is a VERY unpleasant illness. The patient suffers some combination of intense itching and pain for weeks. If the affected nerve is one that serves the face, the eye can be involved and permanent vision impairment can occur. Rarely it can cause deafness if the hearing nerve is involved. The blisters can get a secondary bacterial infection. Rarely, meningitis can occur. Worst of all, since it is affects so many people, 10-20% of shingles victims can develop “post-herpetic neuralgia.” This is intense pain that lasts long after the rash is cleared, often for years, and potentially for life.
OK; shingles is nasty. What can we do to prevent it? First, vaccinate your children. No chicken pox, no later shingles – hopefully 40-50 years from now, shingles will be of historical interest only. For those of us who had chicken pox – and that includes MOST of us 30+ - we must consider getting vaccinated against shingles. If you are 100% sure you never had chicken pox, you can rest easy, but since it was such a mild illness in childhood, it is easy to forget having it. There is a blood test that can tell if you indeed are one of the fortunate few who escaped (and are then at risk of getting chicken pox as an adult – a worse illness!). I ordered the test on about a dozen patients who were sure they had not had chicken pox, and 100% were wrong – they had evidence of having had it.
The first vaccine to prevent shingles was a live attenuated vaccine introduced in 2006, called Zostavax. Live attenuated vaccines use a weakened form of a virus to stimulate our immune system to fight off the real thing. This vaccine was given as a single subcutaneous (under the skin) shot and was very well-tolerated with minimal side effects. The cost is about $160. After being marketed for 10 years, with over 34 million doses used, there were some 23,500 reports of adverse effects, 93% of which were mild. Sounds good – but…unfortunately the vaccine was not as effective as hoped. In the first year after getting the vaccine, the rate of getting shingles was reduced by about 2/3 but by year 7, the protection was less than 50% and by year 11 the reduction in shingles cases was only 38%. The vaccine also proved even less effective in the oldest old, those over 80, who were at greatest risk for both shingles and post-herpetic neuralgia. Also, since the vaccine used a live virus, it could not be used in people with very weak immune systems, such as those on chemotherapy.
Enter the newest contender: Shingrix. This vaccine combines a protein from the virus coat and a naturally-derived “adjuvant,” a non-specific irritant that really juices up the body’s immune system to react to the virus protein. Because there is no live virus in the vaccine, it can be given to patients with compromised immune systems. This vaccine must be given into the muscle and requires two doses, two to six months apart. It is much more effective than Zostavax, giving 97% protection after 3 years, and seems almost as effective in those over 70 as in younger people. What’s the catch? Shingrix has a lot more side-effects than Zostavax. To date, some 84% of people vaccinated reported at least some ill effects, with 17% grading them as severe, compared with 3% of those who got the placebo. Most of these were local soreness and redness, and this generally lasts 2-5 days, though a number of people also felt generally achy and had a fever. The cost for the 2-dose series is about $300, and is covered under Medicare part D plans.
Bottom line: if you or someone close had shingles and you really do not want to get it (and yes, you can get it again), the best way to prevent it is with Shingrix. Try to time it so you can give yourself a few days of R+R and some Tylenol for a few days – do not get it the Friday before a big wedding or competing in the club championship.
Also, since even Shingrix is not 100% effective, it is important to know the signs and symptoms - a painful rash along a very local band of skin anywhere on your body - and it is critical to call your doctor immediately if you see any blisters. There are effective medicines to shorten the course of shingles, but they must be given within 72 hours of the first blister to be most effective. If you note this type of rash late Friday night, you do not need to call the doctor at midnight but do call Saturday morning and do not wait until Monday – and insist on either being seen or treated. With a good description, and perhaps a “selfie” sent as backup, I am comfortable treating shingles over the phone.

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Sunday, February 17, 2019

Are you sure about that? The problem of misdiagnosis

To treat any condition, the doctor needs to know what it is. You would not expect to have your sore ankle treated with penicillin or to have an appendectomy recommended for your sore throat. While this may be self-evident, I know of at least one patient who had a normal appendix removed because the surgeon did not notice the few tell-tale blisters that were warning the careful observer that the lower abdominal pain was due to shingles! I know of several patients who were persuaded to have disk surgery when their back pain was due to arthritis of the spine or muscular in origin; not surprisingly, none of them got any better.
Diagnosis is often easy but at times very hard. A recent review of the disease endometriosis pointed out that there was an average of four to eleven years between a woman first complaining of her symptoms to her doctor and when a diagnosis was made. The National Academy of Medicine has estimated that every one of us is likely to be affected by a misdiagnosis, either in ourselves or a family member. It has certainly affected our family as I detail in Prescription for Bankruptcy. Many misdiagnoses are annoying but not serious, but misdiagnosis has been cited as the number one cause of malpractice suit payouts, and many studies over many years have shown that about 10% of hospital deaths are due to a missed diagnosis.
How can you minimize the likelihood that this will harm you or your loved ones? First of all, be honest and open with your doctors. There is very little you can tell them they have not heard before, and so be frank about your habits and behaviors. When you go for a visit, be sure to get your top priority up front. These days too many doctors are on a treadmill, with limited time for each patient. If you are going in for follow-up of a known problem but you have a new worrisome complaint, get it out there right away. If the doctor thinks they have finished and are about to move on, your new complaint is not likely to get the attention it may deserve.
There are many on-line tools that doctors can use to broaden their approach to diagnosis. I have worked on one, a decision support tool called DXplain, for several decades, and there are others. These can be very useful but they are under-used because doctors are too confident in their own acumen to know when they need to seek help.
When the doctor tells you of a new diagnosis, be prepared to ask them why they think that is what you have: what symptoms or physical exam findings support it. Since the leading cause of misdiagnosis is that the doctor settled on the first explanation for your complaints and did not consider other possible causes, ask them what else it could be – force them to open their mind and at least consider other possible conditions. If they suggest a treatment for this new diagnosis, ask them what you should expect; when you should see improvement and when you should call or return if you do not see improvement. Finally, if you are given a serious new diagnosis, or if the doctor brushes off your complaints as something minor when you are sure it is more serious, do not hesitate to get a second opinion. Second opinions are often very useful. If the second doctor concurs you will have peace of mind, and in many cases they may come up with a better explanation for your complaints.

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Thursday, February 14, 2019

We are what we eat

Doctors tend to treat patients’ ailments and try to prevent disease with pills. It is what we learn most about in medical school. Most doctors give very little attention to diet for several reasons. First, most doctors know little about diet; very little time is spent on diet in medical school curriculums and it is rarely part of our postgraduate education or continuing education courses. We are bombarded with information about drugs in our journals and at medical conventions and we are heavily marketed in our offices by “drug reps,” salespeople for pharmaceutical companies. I never saw a dietician in my office in the 40+ years I practiced. Finally, we are all too well-aware that changing diets is difficult and feel, probably correctly, that it is easier to get our patients to take a pill once daily than it is to change their habits.
At the same time, there is growing evidence that dietary habits have a major influence on our health. Three recent studies brought the point home to me. A report from the long-running Women’s Health Initiative found that frequent eating of fried chicken, fish or shellfish was associated with a higher risk of cardiovascular (CV) disease and death. Another study looked at boys who had fatty liver disease, a condition associated with obesity that has become epidemic in this country. It can go on to cause severe liver disease. They found that a diet low in free sugars resulted in improvement in the liver disease. A third study recently reported looked at the protective effect of a Mediterranean diet on the adverse effects of air pollution in 6 states and two cities in the U.S. Air pollution causes increased cardiovascular disease and death. The people in the study who stuck most closely to a Mediterranean diet had less CV and overall death.
Just as with most topics in medicine, there is a lot of conflicting and confusing information out there. Over the years, I have seen come and go such fads as the Atkins diet, the Scarsdale diet, the “paleo” diet and many others. The only consistent support for health benefits, however, seems to attach to the “Mediterranean diet”. What is this? The Mediterranean diet emphasizes:
• Eating primarily plant-based foods, such as fruits and vegetables, whole grains, legumes and nuts
• Replacing butter with healthy fats such as olive oil and canola oil
• Using herbs and spices instead of salt to flavor foods
• Limiting red meat to no more than a few times a month
• Eating fish and poultry at least twice a week
• Enjoying meals with family and friends. (I think the reason the French live longer is not the red wine so much as it is taking a two-hour break for a leisurely lunch with friends and family.)
• Drinking red wine in moderation (optional). One pleasure doctors don’t have to forbid!
• Getting plenty of exercise
Try it. Hopefully you will like it and you will probably live longer!

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Sunday, February 10, 2019

Should I/he get a PSA test?

Should I have a PSA test?
I expect a lot of feedback on this, as data tends to be overwhelmed by “My (brother-in-law/ golf partner/ accountant) says that the PSA test saved his life.” Read on and react if you wish.
Prostate cancer is the commonest cancer in men (other than low-grade skin cancers), with an estimated 165,000 new diagnoses of prostate cancer in American men in 2018 and about 29,000 deaths. It is increasingly common as men age and at the same time, less likely to lead to death because it is usually a slow-growing cancer. Thus, while it is estimated that the average American male has a 16% risk of developing prostate cancer in his lifetime, he has only a 2.9% risk of dying from it. I would tell my older male patients that if you were to pull all the men over 75 off the golf course and biopsy their prostates, the majority would have cancer. The best data we have shows that by age 80, approximately 60% of men have prostate cancer, but that in most it grows so slowly that they will die of something else before the disease causes any problem.
Historically, prostate cancer was diagnosed by feeling the gland via rectal exam, but this is a very poor way to detect it and certainly useless at picking the disease up early. The approach was dramatically changed when PSA (prostate-specific antigen) came into use as a screening test. There are normally detectable PSA levels in all adult males, and the level rises gradually with age (and the expected enlargement of the prostate that accompanies aging), so the dilemma is in deciding the level that makes cancer likely. Further complicating things is that conditions other than cancer raise the PSA, notably prostatitis (infection of the gland). Both bicycle riding and the rectal prostate exam itself can raise PSA, but usually not by much.
The traditional teaching was that PSA levels under 4 were normal, 4-10 suspicious and over 10 probably cancer, but this simple classification has been questioned. There is no level of PSA that guarantees no cancer, and very big but non-cancerous prostates may have PSA levels over 10. The tradeoff of using lower levels is that fewer cancers are missed but many men who have no cancer will be subject to biopsy. Neither the speed at which the PSA is rising nor the ratio of free to total PSA are definitive enough to give strong recommendations. Hence, if you opt to have your PSA tested, you are accepting the possibility of needing a biopsy. Prostate biopsies are done via the rectum and have been likened to being kicked in the groin by a mule. Multiple samples (8 to 12) are taken and the results are used to calculate a “Gleason score” that grades the cancer and indicates the likelihood of dying from the cancer. There is a small (about 1%) risk of serious infection from a biopsy and similar risk of bleeding
Treating prostate cancer has its own problems. Surgery carries a high likelihood of erectile problems and incontinence of urine, while radiation therapy can cause bowel issues and urinary flow problems.
Multiple studies have been done to estimate the value of screening for prostate cancer, and the results are, to be charitable, inconclusive. A large European trial found that screening would result in 0.7 fewer deaths for every 1000 men screened, while a similar American trial found no difference between men screened and men not screened.
OK then, what should you do? Different groups give different answers, but there is a growing consensus not to screen men over 70 because doing so is unlikely to prolong their life. There is also agreement that it is not worth doing in men under 40 because the disease is so rare. Between 40 and 50 prostate cancer remains rare except in African American men and men with a family history of prostate cancer below age 65, who should follow the same logic as those over 50. For men 50-70, the decision is a classic example of “shared decision making.” Each man will have his own viewpoint on whether the small decrease in mortality is worth the risks of both diagnosis and treatment. In an ideal world, each man would sit down with his doctor and discuss all the issues, but in this day of 10-minute office visits, that is hard to do. Instead, I would suggest you look at one of the web sites that let you explore the pros and cons. My favorites are:
https://www.cdc.gov/cancer/prostate/index.htm
https://www.mayoclinic.org/tests-procedures/psa-test/in-depth/prostate-cancer/art-20048087

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Tuesday, February 5, 2019

How can we keep Gramps and Granny at home?

Most elders would much rather be in their own homes than in hospitals, but our current health care system seems to be organized around hospitals rather than homes. This is not only less desirable but more expensive.
European and other OECD countries spend much less on health care than does the United States but have better health statistics. This is not necessarily an indictment of U.S. hospitals and doctors on quality (though it is on cost), because there are many differences between the U.S. and our western peer countries besides the way our health care system is organized. Europeans on average are more physically active than Americans, walking and bicycling more, and less likely to be overweight or obese. Another very important difference is that while European countries spend much less on health care, they spend more on a variety of social services, including family and child support and housing. Thus, the U.S. spends about 18% of its gross domestic product on health care, while this is 10-12% of GDP in other OECD nations but public spending on social services represents 21% of GDP in other countries and 19.3% in the U.S. To look at this in another way, for every $1 spent in the U.S. on health care, $0.56 is spent on social services while in other OECD countries, for every $1 spent on health care, $1.70 is spent on social services.
How does this difference in spending priorities affect our health outcomes? As noted in prior postings and in Prescription for Bankruptcy, maternal death rates in the U.S. are dramatically worse than in other OECD nations, and infant death rates are worse even though we have many more neonatal intensive care beds. Much of this can be attributed to the very different ways new mothers are treated. In most OECD countries, generous paid maternity leave is the norm, while in the U.S. if it is offered at all, it is likely to be unpaid. This is clearly a reason why half of new mothers in the U.S. do not even keep their six-week postpartum checks.
Two studies published last fall showed how provision of better social services can impact both quality and cost of health care. One, published in JAMA Internal Medicine in October, looked at the impact of community health workers on the health outcomes of a group of low-income veterans cared for at a Philadelphia VA hospital. These elderly veterans had at least two chronic diseases and lived in high poverty census tracts. Not only did the veterans who were visited by community health workers report greater satisfaction with their health and with their care, but they experienced 65% fewer hospital days over the nine months of the study compared with a similar group who did not have these visits.
A study published the same month in Health Affairs looked at how supportive social services supplied to elderly residents of Queens impacted their hospital use. The group studied were residents of subsidized elder housing units who were matched in every way except that one group had access to a variety of in-home services. These included counselling, home safety assessments, wellness and socialization programs and assistance with accessing government programs and in transportation. The group that got these services, compared to a very similar group living nearby without them, had 32% fewer hospitalizations, and when they were hospitalized, went home sooner.
Increasing social support clearly works. How to finance it is problematic. For large agencies that are globally budgeted, such as the VA or the new Medicare Accountable Care Organizations, a good case can be made for them to plunge in and spend the money and expect a good return on their investment. For the nation as a whole, policy makers must be made to understand that investing in these low-tech services may give a bigger bang for the buck than many other ways the money can be spent. Spending money on improved social support will not only make our most vulnerable citizens happier but in the long run it will save money.


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Thursday, January 31, 2019

How safe is that object inside my body?

Medical devices, which range from heart valves to prosthetic joints to insulin pumps, are a huge business, estimated at $400 billion world-wide in 2018. As the elderly population grows, this market will only expand. A major problem world-wide is that the safety and reliability of these devices is not always guaranteed. In the United States there is a fairly robust system for approving new drugs for marketing that grew in large part out of the thalidomide disaster. Thalidomide was marketed in the late 1950s and early 1960s for morning sickness in pregnant women, and resulted in the birth of thousands of babies with major birth defects. Stiff new regulations followed, and pharmaceutical manufacturers are now expected to show both efficacy and safety of their products before they can be sold. As regular readers of these posts or Prescription for Bankruptcy know, I am concerned that in too many cases the medical experts helping evaluate new drugs are beholden to the pharmaceutical industry, but the system generally does work to maximize the cost/benefit ratio of new drugs that come to market. Drug firms must usually perform three trials of their product before it is approved.
The system for approving devices is much looser. There is often only a single trial, and these are rarely if ever randomized or blinded as drug trials are expected to be. In many cases a new device is approved based on it being similar to an existing device. Regulators routinely allow device manufacturers to make major changes to existing products without any formal evaluation.
This loose approach to regulation has resulted in a few but serious problems. The most obvious is the metal-on-metal hip prostheses, which resulted in an unacceptably high failure rate and in some cases led to metallic ions or particles being released into the bloodstream. Johnson and Johnson pulled one of their hip replacement products from the market in 2010 and Smith and Nephew pulled one of theirs in 2012. The lawyers are still having a field day. Essure, a coil-shaped metal device intended to provide permanent birth control, was implanted in the fallopian tubes of over 1,000,000 women. Even though it was designed and sold as a lifetime permanent solution, it was approved for marketing after only short-term (1-2 year) studies with very limited data (25%) going out even as far as two years. Though it seemed safe and successful in the small early studies, thousands of women suffered major complications, including severe bleeding and ruptured tubes. The manufacturer, Bayer, wrote to European doctors in 2017 asking them to stop using the product, but kept selling it in the United States; it was finally taken off the U.S. market at the end of 2018 “for business reasons.” Medtronic marketed an updated version of the wire (Sprint Fidelis) used to connect the control unit to its implantable heart defibrillator in 2004, and it was only pulled from the market 3 years later when a cardiologist published a study showing that it was failing at a much higher rate than other similar products and was either not working when needed or shocking patients (quite painfully!) when the shock was not needed.
The FDA was aware of these problems in its system but was slow to act. An Institute of Medicine panel in 2011 recommended that the FDA replace its flawed approval system that did not really establish either efficacy or safety before marketing. At the time, the FDA disagreed with this recommendation and did nothing. Only when an international group of investigative journalists published a scathing review of the medical device industry in late 2018 did the FDA finally announce that it was going to adopt new measures, and many of these will not take effect for years.
Let me be clear about one important fact. The vast majority of medical devices are both effective and safe. My two hip replacements have allowed me to remain physically active. Properly chosen heart failure patients live longer with an implanted defibrillator. However, despite the fact that most of us are law-abiding, we still need a police force. Even though most devices are safe and effective, we need meaningful oversight. If your prescription medicine proves harmful, you can stop taking it. If a device implanted in your body is harmful, you can either live with it and hope or have an invasive procedure to remove or change it. The FDA must place patients’ interests over manufacturers’ profits.

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