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Tuesday, May 16, 2017

Reducing my cardiovascular risks--the ongoing saga

About 5 months ago I embarked on an adventure in healthcare. My healthcare. I decided to take medicine to reduce my cardiovascular risk. I recognize that my cardiovascular risk is pretty low, and when I am much older I may wish for a nice clean cardiac death before I lose my faculties. Having found a plaque in my carotid artery while ultrasounding myself, I decided that perhaps I should enter the ranks of consumers who take drugs to reduce their blood pressure and cholesterol.

Astute readers made various comments, including that perhaps I should first try diet, weight loss, exercise and that I should be aware that someone of my description has a low likelihood of actually benefiting from drug treatment of these things. These were reasonable comments. It turns out that I don't need to lose weight, being at the bottom of the healthy range of body mass index, and that my exercise level is pretty optimal, my diet is as evidence based as I can make it, and although I have a low risk for vascular disease, the ultrasound says I have it anyway.

I made it my mission to find drugs that would lower my risk of stroke and heart attack without sacrificing my health and well being. This has been surprisingly tricky.

No side effects
If I am to take pills for decades on the small chance that they will keep me from having some vile health event, they need to cause me no trouble. That means they can't make me feel bad and they can't cost very much money. They should also be unlikely to kill me.

I started with lisinopril, an inhibitor of the enzyme that converts angiotensin to its active form. It is an old drug and inexpensive. It can kill me by making my tongue swell up unpredictably, but that is very unlikely. In certain circumstances it can cause kidney failure, but it can also prevent kidney failure. It is usually quite effective in reducing blood pressure. My pharmacy charges just over $1 for a 1 month supply. I found that it wanted to get stuck going down my throat (it's not very slippery) and that at a low dose it didn't do much to lower my blood pressure.

Statin drugs reduce cholesterol and reduce vascular disease, though their effects in patients who have not had any cardiovascular events are minimal. Atorvastatin is pretty cheap, less than $10 a month through my pharmacy. It can definitely make my muscles weak and painful, but I haven't noticed that so far. If it does make me weaker, I may never be aware of that, just thinking that I am experiencing normal aging. Since I am hoping to buy vibrant health, that would be a nasty little irony. It almost never kills anyone, other than by causing a slight increase in the incidence of diabetes, which definitely does kill people. My physician told me I had to take it at night, which means that I forget to take it most of the time. The reason that a person should take a statin at night is because it works best during fasting states. But atorvastatin is a long acting statin and can be taken any time of day. Now I will start being more compliant, taking all of my pills at the same time, vaguely with breakfast. After my first month of taking it nearly every day, my cholesterol was lower than it had ever been, well within guidelines. Whether this is a relevant surrogate measure for any sort of health benefit, I'm not sure.

Chlorthalidone or Atenolol/Chlorthalidone
A recent meta-analysis showed that chlorthalidone, an old and less frequently used thiazide diuretic, may be more effective than its sister drug, hydrochlorothiazide (HCTZ), in preventing cardiovascular disease. Other studies have shown that it is more potent, milligram for milligram and more long lasting. Unfortunately it is also more expensive than HCTZ by a factor of more than 10. It is, however, cheap when combined with atenolol, a beta blocker. (Why it is more expensive than its newer relative and less expensive in combination with atenolol is another story that has to do with the dysfunctional economics of drug pricing.)  Thiazide diuretics can lower the potassium level and the sodium levels and by that mechanism can kill people, but this can be monitored and is rare in its most severe forms. Beta blockers have been associated with dangerously low heart rates in some people along with weight gain and depression, but this is not common. I tried the combination. I had to get up and pee more often at night but otherwise it was innocuous. It did not lower my blood pressure very much if at all.

Lisinopril in combination with a thiazide diuretic such as HCTZ or chlorthalidone is much more effective than either drug alone. They make a generic combination pill and it is also very cheap, just about the same price as lisinopril alone. I got a prescription for 90 of these, and after having taken 2 found they controlled my blood pressure very nicely, were easy to swallow and made me itch and burn in my sun-exposed areas of skin. HCTZ is well known to do this. Chlorthalidone can too, since they are similar in structure, but it didn't have that effect on me. Know anyone who needs 88 lisinopril/HCTZ tablets?

No drug manufacturer in the US makes a combination pill of these two, and I'm betting when they do it will be expensive. But I did, after all, try taking lisinopril plus a half of an atenolol/chlorthalidone pill which has caused no side effects other than the annoyance of the lisinopril pill taking its time to navigate my esophagus. Hooray! Maybe. It probably gives me a little tickle in my throat. This is classic for lisinopril and is very subtle indeed for me. I don't cough all the time, but find that as I fall asleep or am otherwise not occupied, I notice the need to cough or have a sip of water to clear the tickle. This is nearly a deal breaker, but I am willing to wait awhile and see if it persists. This combination works well for my blood pressure.

Why not? Aspirin reduces the tendency of platelets to clump and form clots, so it should reduce my risk of strokes. It will also increase my risk of significant bleeding. Aspirin is a non-steroidal anti-inflammatory drug, and even though low doses do not work to quell knee or back pain, they can cause ulcers or heartburn. I had heartburn as a wee medical student but haven't had it for years. As a new aspirin user I have it again. Nothing terrible, but not nothing.

So theoretically I am now on lisinopril, atenolol/chlorthalidone, atorvastatin and aspirin. They pretty cheap, around $10/month for everything. That still is $120 for a year and $1200 for 10 years and likely to go up in price with time. I am a little more miserable than I was on no drugs at all, and I am being bad about both compliance (taking the pills all the time) and followup. My chance of benefiting from these drugs is low. The pills are on probation.

It is important to ask, while contemplating a lifelong commitment to deliberately putting toxic chemicals into my body, if my data is sufficient. My blood pressure runs 140-160/90-94 untreated (though it is quite normal after 20 minutes of meditation.) We know that treating a population of people to bring their blood pressure down below those numbers reduces heart attacks and strokes, but do we know that my blood pressure, in the setting of otherwise good health, is harmful at all to me? I have a carotid plaque: it is not obstructing flow to any extent, but is impressively lumpy and looks like Mt. Fuji on one view. It is calcified, so it has been there awhile. It probably formed before I even had high blood pressure. Did it happen in the physical stress of childbirth? Was it formed in any of the stressful years when bad life events disturbed my otherwise charmed existence? Is it merely a signpost indicating a path not taken, or will it eventually be one of many? In a nutshell, am I just fine the way I am?

So far the experiment with pills has not been a big win. I have definitely gained, however, from the experience of being a patient, though a mighty privileged one. I have learned that side effects are real, even if they aren't on the package insert, and may be in categories like inconvenience, worry and always wondering if I have a side effect. I have learned that effective medication can be pretty inexpensive, but that the dollar cost belies the expense associated with the life disruption that taking pills can have. And that even cheap pills add up over time. I've learned that when effective medication doesn't have the desired effect, it is sometimes because the patient isn't taking the medication, but sometimes because a given pill just doesn't tweak a given person's physiology in a way that works. I've learned that even though I consider myself to be very tolerant and easy going when it comes to physical hardship, if I mentioned all of these concerns to a personal physician I would almost certainly sound like a whiner.

Monday, May 15, 2017

Bystander CPR--some interesting statistics

"Annie, Annie, are you OK?"

Many of us learned to resuscitate a person who has collapsed using Annie, the manikin based on a death mask of a young woman who had drowned in the Seine in Paris in the 19th century. Bystander cardiopulmonary resuscitation (CPR) has become increasingly accepted and expected as the years have passed, and we have even begun to make affordable machines to deliver a life-saving shock (defibrillation) to the heart of a person who has collapsed with an otherwise life threatening heart rhythm disturbance.

We lack, though, much good information about how useful the procedure is in saving lives and bringing people back to meaningful existence.

A recent study completed in Denmark looked at the outcomes of bystander performed CPR and defibrillation. Denmark has been quite aggressive in training and encouraging citizens to perform CPR when a person collapses and is found to have no pulse. They have also been scrupulous about keeping records of what happened in each of these cases. Records spanning 2001-2012 show that having bystander CPR helps a person to survive with their brain intact, more than just waiting for an emergency medical technician to arrive with the ambulance.

What is most interesting, though, is the overall outcome of cardiac arrest. In the period of study, 8.3% of patients on whom resuscitation was attempted survived for 30 days. Of these, 10.3% had brain damage or were admitted to nursing homes. As bystander CPR became more common, the percentage of patients surviving cardiac arrest rose, and was over 12% by 2012. Also, compared to no bystander CPR, those who received bystander CPR were much less likely to end up in a nursing home. The group of survivors with the best outcome were those who were treated by bystanders with an automatic defibrillator; only 2% of those survivors had brain damage. Of the patients who survived for 30 days, 9.7% died in the subsequent year, most often of heart disease.

So, to recap, slightly more than 1 in 10 Danes who collapse and receive cardiopulmonary resuscitation survive over 30 days. Of those who survive, about 1 in 10 will have brain damage sufficient to require nursing home care. Since Danes have healthcare statistics pretty similar to Americans, this study may represent us pretty well. Getting cardiopulmonary resuscitation as soon as possible, in most cases this means by a bystander, probably gets the blood flowing to the brain sooner and helps prevent brain damage in survivors. Having a defibrillator available and using it is even better.

It is a powerful thing, being able to bring someone back from death. If we choose to engage in it, we should stay skilled, start right away after a person collapses, be aware of defibrillators in the places we frequent and plan to use them, and understand our limitations. For those of us who don't want the to receive vigorous resuscitation with a significant risk of failure or brain damage, displaying this preference, possibly with a medical alert bracelet or necklace, may be wise.

Tuesday, May 9, 2017

Don't look hard for thyroid cancer--you will probably find it

Gilbert Welch has written an excellent commentary on the fresh-out-of-the-printer recommendations of the US Preventive Services Task Force (USPSTF) regarding screening for thyroid cancer. Dr. Welch, a professor at Dartmouth University, has spoken out about wasteful and harmful procedures done in the name of prevention. He is a compelling writer, has written several books aimed at people who are not doctors, and has captured the essence of the thyroid cancer screening controversy in this article, published in JAMA today.

Briefly, he applauds the recommendations of the USPSTF which state that there is no evidence that looking for thyroid cancer in people who have no concerning symptoms (symptoms such as a neck lump, difficulty swallowing or hoarseness) helps them. He looks at the population data on thyroid cancer, first evidence out of Finland that suggested that nearly everyone probably has a small thyroid cancer if you look hard enough, and evidence that discovering and treating these tumors does nothing to reduce the rate at which people die of thyroid cancer. Death from thyroid cancer has always been very rare, and thyroid cancers are pretty common.

He also discusses how the USPSTF can continue to develop recommendations which are based on evidence but often go against what is commonly done by physicians. The panel is made up of volunteers who are physicians in primary care and epidemiologists, medical professionals who study how disease occurs and can be controlled in populations. This limits conflicts of interest since none of these professionals stands to gain from promoting or discouraging given procedures. Apparently in November of 2016 legislation was introduced to put specialists and representatives from industry on the USPSTF. It did not pass, and should not be allowed to pass if it is introduced again. Screening for thyroid cancer results in many people being diagnosed with thyroid cancer which would never harm them if left untreated, but will result in hefty medical costs which will go to endocrine specialists, surgeons, pharmaceutical manufacturers and radiation providers. It is vital that task force members not be connected to fields which would gain or lose based on their recommendations..

Those of you who have been following this blog may recall the saga of my very own thyroid nodule. Much like many of my fellow humans who have been overdiagnosed with thyroid cancer, my thyroid nodule was discovered by an overzealous doctor. Actually me. I hadn't had a physical exam in awhile and thought maybe I better check myself out to see if there was anything amiss. I discovered a small lump in the right side of my neck. Being skilled in ultrasound, I headed down the very same garden path trod by the ranks of the overdiagnosed and had a scan (by me) of the nodule. It had characteristics that were benign and ones that were suspicious. I chose to follow it along for a year or more, but was alarmed when I heard that even benign appearing thyroid nodules sometimes harbored thyroid cancer. I was lucky at this point, however, when my thyroid biopsy (which hurt a lot and was very expensive) did not show cancer.

With the present guidelines, I would have spared myself multiple repeated ultrasound scans (all free in my case, because I did them myself) and the fear that persisted over the time that I followed the nodule as well as thousands of dollars and a very sore neck. Had thyroid cancer been discovered, and data suggest that it is probably there somewhere, I would have also had surgery, radiation and regular followup for recurrence, putting me at risk for complications and costing many tens of thousands of dollars, to say nothing of work lost, anxiety, pain and inconvenience. The new recommendations of the USPSTF will likely draw criticism. Those recommendations appear to me to be well considered and right on target.

Do read Dr. Welch's commentary. He is an excellent writer. Also be aware of the great resource we still have in the USPSTF which can say true things that might be unpopular with other powerful interests.

Thursday, May 4, 2017

How reduced regulation by the FDA will save money--except not

There is enthusiasm in politics about reducing regulation to stimulate creativity and economic growth. Maybe. But reduction in oversight of medication and medical devices by the Food and Drug Administration (FDA) will probably lead to a proliferation of expensive potions and gadgets that don't actually help.

This week, the New England Journal of Medicine published an article detailing the near miss associated with an injectable monoclonal antibody for Alzheimer's disease. (Spoiler alert: it doesn't work.)

Authors Chana Sacks, Jerry Avorn and Aaron Kesselheim detail the saga of Solanezumab, a drug that attacks the protein in the brain that is associated with Alzheimer's dementia. A monoclonal antibody is a molecule that binds to a specific target allowing the immune system to clear it from the body. Solanezumab binds to amyloid beta protein which is increased in the brains of patients with Alzheimer's disease. Although it may help clear amyloid protein from patients' brains, it did not help patients' brains to work better. It wasn't clear that the drug was worthless until all of the studies that the FDA required were completed. In fact, before the final, costly and rather time consuming trial, it looked like it might help patients with mild dementia. But it really doesn't help.

Because so many people have mild dementia and are desperate for a way to delay or reverse it, this could have been a very sought after drug. We don't know what it would have cost, but we can guess that it might have been similar to other monoclonal antibody drugs on the market, ranging from $14,000 to nearly $30,000 per year. There are several million people in the US who have mild dementia, so the cost to Medicare, private insurance companies and individual patients would have been in the many billions of dollars each year.

Drugs can be very good at changing blood tests or pathology slides without being good at all at changing patients' health.

I will digress a bit here, on the subject of expensive monoclonal antibody drugs that don't actually do much to help people. Evolocumab (Repatha) was approved by the FDA recently as an injectable drug to reduce cholesterol. This it does incredibly well. Read about it here. It has finally undergone testing to see if it really does any good by reducing cholesterol so dramatically and the results were hailed as a victory. The study enrolled patients with heart disease who were already on medication that had reduced their cholesterol. In this group, evolocumab actually does reduce the incidence of strokes, heart attacks, heart surgery or stents, hospitalizations for unstable angina and cardiovascular death, but only just a little bit. At the cost of over $14,000 per year for the injections, it saves only a few patients receiving the drug from these events at a cost of nearly $1 million per event avoided every year. If you only look at death or death from heart disease, there is no difference between patients who take the injections and ones who do not. Since the initial studies done for approval of this drug only looked at safety and the drug's ability to reduce cholesterol, it wasn't clear until after it was in clinical use that it didn't actually work that well for the outcomes we care about.

There are other drugs in other classes that looked like great ideas and weren't, and they either cost the taxpayer loads of money as we finally figured this out, or died in clinical trials. Drugs that increased the strength of the heart to treat heart failure often fell in this category, and, if they had been adopted in standard clinical practice, there would have been needless deaths in addition to needless costs. There are other drugs that appeared safe and were eventually taken off of the market when monitoring by the FDA showed significant side effects. The FDA monitors and approves (or doesn't) not only drugs, but also medical devices, food, cosmetics, veterinary products and machines which emit radiation. Its budget is $4.7 billion, of which not quite half is paid by the companies it monitors.

We should not ask the FDA to reduce its oversight of medication. What would be more helpful would be to increase funding for their efforts so they can do a better job and even complete an approval process more quickly when it's indicated. Perhaps an FDA with more funding and more teeth, not less, might have been able to be firmer with the makers of evolocumab, requiring it to show more efficacy before it was rolled out to physicians and patients eager to try something new to reduce the risk of heart attacks. The FDA's work on solenazumab, the Alzheimer's cure that wasn't, more than paid their cost to the taxpayer.

Sunday, April 2, 2017

Medicaid and the national debt--why should we shell out so much money for healthcare for the poor?

Medicaid, the program that provides funding for adults, seniors (along with Medicare), children and people who are blind or disabled who can't pay for their own healthcare, is expensive. It is painfully expensive. The program, along with CHIP (the Children's Health Insurance Program), marketplace subsidies and Medicare is responsible for 25% of the federal budget. Total Medicaid costs in 2016 were around $532 billion per the Kaiser Family Foundation. States fund up to half of the cost of Medicaid, and in my state, Idaho, our share of Medicaid and related payments makes up about 21% of the state budget.

Medicaid is a safety net that allows people who can't afford private insurance or to pay out of pocket to get healthcare. It pays for doctors' fees, preventive care services, hospital care, mental health care, the majority of women's costs for pregnancy and childbirth and costs for the impoverished elderly who are in nursing homes. It pays for emergency room visits. It pays the costs of care for people who are uninsured and become sick and their healthcare debt makes them so poor that they are then eligible for Medicaid. With small exceptions, all medical bills for those insured under the program are paid by Medicaid, with none of those nasty co-pays left over. It often pays less than other insurance companies for the same services so some providers will refuse to accept Medicaid insurance, but the full spectrum of care is available to patients including such things as organ transplants. Medicaid has different names in different states: Oregon Health Plan in Oregon, Badger Care in Wisconsin, MediCal in California for instance. It has been expanded in  32 states under the Affordable Care Act to cover people making up to 138% of the federal poverty line.

Presently the federal government pays a percentage of the medical bills of the Medicaid insured patients and the states pay the remainder, usually a smaller amount. Medicaid block grants, which have been proposed by Republican lawmakers, would still pay the majority of Medicaid costs, but would pay a fixed amount, rather than a percentage, and that amount would increase at a rate slower than the predicted increase in healthcare costs. Thus the federal government's share of the bill for Medicaid would gradually shrink. This proposed change is temporarily on hold due to snags in Republican's efforts to produce and pass a healthcare bill to replace the Affordable Care Act. I and many other people have shared opinions about block grants over the last month. The bottom line is that they would likely shift costs from federal to state governments without making a major impact on overall costs.

But the real question that arises, as we consider reducing payment for Medicaid, is why we should pay for it at all. That question underlies the question of how to fund it or whether to increase or decrease the resources we put into it. Why should those of us who are taxpayers, especially wealthy and therefore hefty taxpayers, put such a lot of money into a program that pays for the healthcare of people who, by their status as patients qualifying for Medicaid benefits, pay little or nothing in taxes?

This is an awkward and uncomfortable question to ask. My first response, as a person who believes in the inherent worth and dignity of every human, is possibly misguided. That answer, based on a kind heart alone, is that we pay for healthcare for the poorest and most vulnerable because it is the right thing to do and it would be terrible for people to die or suffer from treatable or preventable diseases because they don't have the money to pay for care.

But, according to The Economist, many of the other countries in the developed world came to take on the responsibility of universal healthcare because it was extremely inconvenient to have many of one's citizens sick, especially when they were necessary to staff a war somewhere. To take this further, the best argument (or at least the most robust one, from a political standpoint) for providing healthcare to the poor is that a healthy population makes for a more successful country. People who aren't disabled by chronic diseases or the sequelae of epidemics tend to be better workers, invent more things and require fewer subsidies.

But how can we tolerate, in all good conscience, the staggeringly large national debt that is necessary to fund a program like Medicaid? Our federal deficit last year was $572 billion, almost the same number as our spending on Medicaid. If we just cut Medicaid completely, we would be nearly deficit free. Aside from the fact that eliminating Medicaid won't even begin to be a possibility, and that it is a terrible idea for all sorts of reasons, it is financially stupid. Our debt, alarming as it may be, can be looked at as using borrowed resources to create a healthy and productive country. Paying interest on that debt is the cost of maintaining programs, such as Medicaid, that make us more productive. Debt is a good bargain if we get more in productivity than we pay out in interest.

The most important question, then, is not how to reduce the costs of Medicaid but how to get good value for our money. Medicaid, in order to give good value, needs help. It has excellent aspects. It provides healthcare for many children. That is clearly a good investment. Children, when healthy, grow up to do great things. It cares for poor families who have children, which is clearly a good investment, because healthy families are more likely to raise children who are healthy, creative and self sufficient. It pays for nursing home stays for the elderly after they can no longer afford to pay for themselves. Right now that is vitally important because families and friends who would be required to care for them at home can be freed up to do all of the things that they were intending to do, including jobs and education. Designing ways to allow the old and disabled to be at home rather than in institutions would be better, and that is a direction that Medicaid is trying to take. Caring for people with developmental disabilities or disabilities relating to injury or illness is important because this is specialized work, and not everybody, including their families, necessarily does it well. This is a valid role for Medicaid (though plagued, like much of healthcare, with preventable waste.)

Medicaid's real weakness is that it pays and keeps on paying for the diseases of self abuse and is not designed to make the necessary social impact to prevent the misery that leads to the problems of drug abuse, interpersonal violence, alcoholism and morbid obesity. The endless circle of getting sick or injured because of poor life choices in impossible situations, being patched back together at astoundingly high cost and then returning to the same situation to repeat the process is demoralizing for all involved. From an economic standpoint, it is also Medicaid money wasted. Solving this problem involves creating healthy communities. It needs to happen despite the fact that the people who need this help have close to no political clout. We must continue to treat these people when they come in sick and in need because it should not be the job of caregivers or payers to decide who is virtuous enough to receive care. But Medicaid does not function in a vacuum, and cannot give good value if it is not supported by other well designed social programs, designed to prevent their illnesses. Until we are able to focus reform efforts on the social problems that create some of our sickest and most hopeless patients, a substantial portion of public healthcare spending will not be a good investment.

Saturday, March 25, 2017

Bedside (Point of Care) Ultrasound of the Lung--So Good

Last week was a big week. Many patients. Lots of bedside ultrasound.

I've blogged on and on about my undying love for ultrasound at the bedside as a part of my physical exam. It keeps being powerful. It saves peoples' lives. It keeps me from making stupid mistakes. I am eternally grateful.

This week it helped with the usual things--hearts and bellies and bladders and lumps and bumps. I was able to tell patients what was going well and not so well, in real time, and show them pictures.

But ultrasound of the lung needs a little advertisement. Ultrasonographers and radiologists are terrific at imaging the internal organs, even those of tiny babies. Cardiologists and echocardiogram technicians are amazing in their ability to image the heart and describe its innermost workings. Although I leverage my ultrasound abilities by using my other exam and history taking skills, I do not have the extensive training in imaging that these people do. But in the US, only clinicians such as myself look at the lungs. Radiologists may look at the bases of the lungs for fluid, in order to more accurately sample or drain that fluid. But they don't look for pneumonia or pneumothorax (popped lung) or make predictions about the quality of pleural fluid based on what it looks like. So there is no question that the lung belongs to us, the non-radiologists.

This is a collection of 5 patients whose lung ultrasounds made an important difference in their care:

1. An ancient man, whose esophagus was completely non-functional, had continued to eat food despite the sneaking suspicion that it wasn't going down all the way. When he finally became too uncomfortable, his esophagus was packed with several meals and he was unable to swallow even his own saliva. The obstruction was relieved, but he then had a fever. Ultrasound of the lung showed the aspiration pneumonia that I suspected and I was able to decide on the appropriate treatment. He was so out of it after his procedure that he probably would not have been able to take a deep breath and the chest x-ray would probably have been inconclusive, and the ability to diagnose his condition with ultrasound meant that he did not need to be disturbed.

2. A woman arrived with a low oxygen level, kidney dysfunction and a bit of a wheeze. She had an elevated white blood cell count but no fever. Her ultrasound showed normal appearing kidneys and a left sided pneumonia. She responded well to antibiotics for community acquired pneumonia with increasing strength, no further need for oxygen and normalization of kidney function.

3. An octogenarian with endstage lung disease was short of breath a day after being started on bipap (bilateral positive airway pressure via mask). The nurses were unable to hear breath sounds in one of his lungs and were worried he might have a pneumothorax. A very quick check for lung sliding with my pocket ultrasound machine (the two layers of pleura moving against each other) proved to me, the nurse and the respiratory therapist that his problem was worsening airway obstruction rather than a pneumothorax. The patient was also happy with the attention. He was better by the next day.

4. A previously healthy young man came in with shortness of breath and a test positive for influenza. His ultrasound showed pretty significant pneumonia, due entirely to his influenza. It was clear that he needed to be hospitalized rather than sent home. His chest x-ray was equivocal. Ultrasound is definitely more sensitive for pneumonia than a plain chest radiograph, though determining the meaning of a wet area or consolidation depends on paying attention to other clinical information.

5. A patient hospitalized for another problem began to have increasing leg swelling and a slightly lower oxygen level. Ultrasound showed pleural fluid collections and he responded well to an increase in his medication for heart failure. Emergency decompensation averted. What I knew about the patient as well as the quality of the pleural fluid on ultrasound made it clear that this was related to his fluid status and not infection.

Radiologists do not look at the lung with ultrasound because normal lung looks like nothing, just gray fuzz with some horizontal stripes.This is because lung is filled with air like a slab of micro-bubble wrap and does not transmit sound well. They also have other imaging techniques, such as x-ray and CT scan which give them better static pictures. I'm sure they could develop advanced techniques for detecting pathology using ultrasound if they set their minds to it, but for now it belongs to us.

Thursday, February 16, 2017

Universal healthcare and a single payer--definitely not the same thing.

I hear many of my progressive friends say that "obviously what we need is a single payer." That could work, but it is definitely not a sure thing. Overall what we want most is universal access to healthcare at a cost that is affordable.

Why, some may ask, does it need to be affordable? Why can't it just be free, like in Canada?

That's a wonderful thought, sort of. It also ignores the big truth that healthcare is like any other resource and is not free. It is always paid for by all of us. The difference between a single payer and multiple public and private payers, which we have now, is the degree to which we feel the pain of paying for it. Healthcare costs are paid by our employers, and thus from our wages, our taxes and directly from our purses in the forms of premiums and copays.

There are problems with universal access to healthcare, too. As a nation of people with various values, it is probably safe to say that most of us want sick people to be able to go to a doctor or hospital and get the help they need. And, if it makes it so that there are fewer people getting sick and thus more people who are happy and productive, we could probably agree that we want interventions that will prevent illness, things like vaccines and preventive testing for treatable diseases. But what about nursing home care and transplants and the newest drug therapy for chronic diseases and expensive medical devices? Is this stuff included in what we believe is essential to offer people in order to be a civilized nation? What about critical care interventions for people who drink too much or use injectable drugs and continue to do this despite developing health problems? What about smokers who get chronic lung disease and cancer and continue to smoke? What about the ravages of obesity, including diabetes and osteoarthritis? What do we do about the associated need for ever more costly new antidiabetic drugs and joint replacements? Is there a point at which we cannot reach consensus?

Having our diverse collection of private insurers does allow for some creative approaches to the above dilemmas. They can adjust the cost of their product based on certain unhealthy behaviors. They are free to develop programs to help people eat less, exercise more or go in for regular preventive maintenance. With multiple private insurers competing, this becomes less restrictive.

A single payer could build some of these same incentives and could potentially do some other things to reduce costs. It could negotiate with the various segments of the healthcare delivery system in order to reduce their charges. Many services are excessively expensive and prices could probably come down with some pressure from a single payer who was the only client available. If that single payer is the government, it could potentially do some innovative things to reduce costs.

If a single payer were to notice (as many doctors have noticed) that some of the most costly patients were ones who abuse drugs or alcohol, resources could be directed outside of healthcare to reduce those risks. Rehabilitation programs might be targeted for more funding, but more effective would be to support high risk communities where education is poor and there are few decent jobs available. This is something that a private insurance company has no ability to do.

What is kind of strange, though, is that we do have a single payer for a large portion of Americans: almost 1 in 3 of us is insured by either Medicare or Medicaid. But they don't negotiate prices of medications or devices or many services and they don't have fun and accessible programs to increase healthy behaviors and, as far as I'm aware, they don't target high risk communities for improvement projects as a way to reduce healthcare costs.

What makes our government unable to control costs, then? If we are thinking about having the federal government be our single payer, we should consider its success in managing the healthcare of over 100 million people now under its umbrella. It is possible that the existence of private insurers that will pay more than Medicare or Medicaid rates limits these government funded payers from lowering prices still further. I think, though, that the inability of opposing sides to work together to come up with solutions is at the heart of it. Our government has become one in which the two parties definition of success is to obstruct the ideas of the opposing party. The fact that congresspeople can serve many terms means that everyone is trying to appear to their constituents to be the most magnanimous and to make their opponent appear to be stingy and unkind. At the same time they are attempting to please powerful business interests, particularly in the healthcare industry, in order to benefit from generous campaign contributions. Ideas that would cut costs by limiting benefits or reducing reimbursement can also reduce the chance of being re-elected. Moving resources to underserved communities buys few friends among the powerful.

On the other hand, Medicare probably does deliver healthcare with lower administrative costs than private insurance. Although it is not free to recipients, most of them love their insurance, which is more than most private plans can claim.

So what, then, is the best route to a universal healthcare system that can control costs and encourage people to take better care of themselves? Our present system, under the affordable care act, has provided a framework in which increasing numbers of people were covered by a single payer, though Medicare and expanded Medicaid. It did not allow people to buy into Medicaid when they made more money than 138% of the poverty line, which would be useful. Instead, it subsidized private insurance to do the same thing which has run into some problems. Offering either Medicare or Medicaid for a fee based on a sliding scale for income would allow people to move further toward a single payer without taking away private insurance companies' ability to do business. Private insurance might continue to innovate in ways that larger scale federally funded healthcare could not do. Independent healthcare cooperatives such as Group Health/Kaiser Permanente could do the same. Cost pressures on federally funded healthcare might lead to price negotiations and attempts to address the social causes of the diseases of self neglect.

I and, I suspect, the vast majority of Americans would appreciate bipartisan work on patching together universal healthcare out of the unstable bits and pieces that are presently making a mess of it. That may require changes in government that seem far removed from healthcare reform, such as term limits and campaign finance reform. It is not going to be simple and will likely involve both compromise and willingness to make some sacrifices.

Saturday, January 28, 2017

Health insurance as a contributor to high medical costs

After writing about the coming demise of the Affordable Care Act, I began to think, again, about why it costs so much to deliver healthcare in this country. If it was cheaper, legislation to make healthcare a right, rather than the randomly distributed privilege it is now, would be so much easier.

Medical costs doubled every decade from 1960 through 2000. This happened in tandem with the rise of comprehensive health insurance. Today the vast majority of health care is paid for by some sort of health insurance. Hospitals and physicians spend a huge amount of time generating information to convince insurance companies to pay us. Patients aren't usually aware that more than half of the time doctors or nurses spend at work is used to document what we do. These days it is primarily on a computer. The documentation can be helpful to communicate our thoughts and plans to colleagues or keep a record of what happened so we can create a history that caregivers can read at some future time, but the majority of it is to prove to insurance companies that we worked hard and we did what we were supposed to do. There are also many employees of a hospital or a clinic who are employed primarily to communicate with insurance companies so we can be paid. I've heard it estimated that 50% of human hours in a hospital is devoted to billing. This rings about true, though I think that if we were to examine all of the adjustments we have made over the years that are due to our payment system, we would find the percentage to be higher.

In an attempt to make us do our jobs better, we are monitored for the quality of our care as measured by adherence to certain guidelines for serious diseases in the hospital. It is cumbersome to develop the tools we need to report on, for instance, how we treat sepsis (overwhelming infection.) The data regarding how to do this best is still actively evolving and new recommendations seem to show up in the good journals a few times a year. By the time we have our tools developed, the newest recommendations have changed and insurance companies are still judging us based on outdated guidelines.

The amount of administrative complexity associated with insurance billing is huge and requires the insurance companies to employ large numbers of people. Each of these people's salaries and the new large buildings they sit in are part of medical costs as well and are reflected in insurance premiums and become part of the cost of delivering healthcare.

Insurance includes not only private health insurance companies such as Blue Cross and Humana, but also federal and state administered insurance, Medicare and Medicaid. Public and private payers have very similar inefficiencies built into their systems. Public insurance providers, at least in theory, have another level of inefficiency built in since they not only are large bureaucracies using complex schemes for paying for services delivered to people who are far removed, but they also require expensive legal processes to be funded.

There are other parts of the equation that add up to high medical costs, and some of them have their very own devoted blog posts. A third party payment system, such as we have, along with fee for service payment for medical care are a recipe for rising costs.

It would be jolly to dismantle such an inefficient system, except that it would also be economically horrific on a national and possibly global scale. Nine percent of Americans are directly employed in the healthcare industry. This doesn't include all of the people employed because we have a large and growing healthcare industry. It doesn't include the postal worker who delivers health related junk mail, the construction workers who build the new health insurance building, the people who polish the Mercedes Benz of the CEO's of hospitals, the devoted teachers who educate healthcare workers or the many other people who thrive or survive because the healthcare industry is booming. Reducing costs by making a major cut in the way we do business, such as getting rid of private insurance companies, would have far reaching consequences on employment and the economy.

This is one of the reasons that changing the way we do healthcare is so tricky. Perhaps we want to continue to spend lots of money on healthcare because it is a quirky thing we Americans like to do. Even so, it seems like it should be possible to have better outcomes for all of the money we spend. We ought to be able to winnow out the parts of the system that don't add value. In order to make such changes, we should go slow, creating alternatives that prove their value and edge out present less functional systems.

Creating a national health care system, a single payer, seems almost attractive enough to make what would be a huge and potentially catastrophic change. Canada and France, both of whom have systems that provide healthcare for every citizen at a cost that is lower than that in the US, use single payers. In Canada, with which I am more familiar, this makes billing incredibly simple and actually possible for a doctor to do him or herself quickly and without help. Patients do not pay for anything except for most drugs, dental care and some other necessities that are specifically excluded from coverage. Instead they pay a hefty but income adjusted tax to pay for the entire system, called Medicare. There are some private health insurance companies that people sometimes use to pay for those things that are not included in Medicare coverage, but this is a small fraction of the healthcare industry.

It could be argued that we have tried very hard to make a healthcare system work with a hodge podge of public and private funding and that it clearly hasn't worked, with rising prices and far from universal coverage, even with changes wrought by Affordable Care Act. A single payer system is the cure for our ills. A single payer could negotiate with providers of healthcare services, setting prices and examining new technology based on its costs and benefits. There are problems, both practical and theoretical, with this answer. As far as the theoretical issues, it is usually better to allow private businesses to create solutions to needs such as healthcare since they can be more innovative and more flexible than large governmental agencies. If the federal government designs a healthcare system there will be a tendency to create "one size fits all" solutions, which don't lend themselves to the truth that every person is different and has somewhat different healthcare needs.  Practical aspects include the fact that we presently have a federal government which is far too influenced by powerful lobbies and thus probably can't actually negotiate better prices. Other creative solutions to improve quality with innovative ideas require the ability of lawmakers to work together, listen to each other and develop compromises, which they appear unable to do. There is also a pervasive distrust in the federal government that means that the majority of constituents would likely not trust them to manage healthcare. It would, in fact, be a huge change in how things are done and the road would be very bumpy.

It is very difficult to think our way to a perfect and universal healthcare system. It will require small and sometimes courageous steps in the right direction based on a shared concept of what we want as both providers of healthcare and consumers.  It will require leaders who thrive on working together to find new solutions. It may involve private insurers as well as public and it may even transition to a true single payer. In the end it will need to be a flexible and high quality way to provide good health to everyone at a price that we can afford without pinching the rest of the economy.

Sunday, January 22, 2017

The Affordable Care Act (aka Obamacare) on the chopping block

The Patient Protection and Affordable Care Act (ACA for short, or Obamacare as it has come to be known) was passed on March 23, 2010 after intense wrangling and many compromises. It is a huge and complex bill which changed health insurance costs and availability significantly, resulting in over 20 million Americans getting health insurance who were previously uninsured. Many people can now get health care without impoverishing themselves, but the bill is also not without significant and possibly fatal flaws.

What does it do?
The link here is to a blog I wrote in early 2010 after a grueling 5 hours of reading the bill that was eventually passed. The things people like about it include:
  • Health insurance can be bought through "exchanges" which make it easy to compare plans and purchase insurance. 
  • The wording of policies has to be understandable for regular people. 
  • An insurance company can't refuse to cover a patient because of a pre-existing condition and insurance rates can't be hiked due to being in poor health. 
  • Adult children can remain on their parents' insurance until age 26. 
  • Insurance companies can't stop paying medical costs after a certain ceiling amount and can't kick someone off due to medical problems. 
  • Procedures considered to be effective prevention need to be covered 100%, without a deductible owed by the patient. 
  • Private health insurance is subsidized for people with low income and free insurance is available for people at even lower income through the Medicaid program in those states that have chosen that option. Nineteen of the fifty states, however, have opted out of expanded Medicaid.
  • For most people buying health insurance through the exchanges, health insurance premiums will be affordable due to subsidies.
  • There have been innovations designed to improve both cost and quality.
What's wrong with it?
  • Although health insurance is more affordable for most people and now covers preventative services, it is also required. If the insurance companies have to agree to insure patients who are going to cost them lots of money, they also need to insure patients who won't cost lots of money or their costs will go up and they will no longer be able to make a profit. The requirement to buy health insurance is called the individual mandate and is enforced by a penalty charged on income tax of up to $695 for an individual who has not paid for insurance for a year. The amount of the fine is capped at the cost of the cheapest insurance available. The idea is that you can either pay and get insurance or pay and not get insurance. People don't like being told they have to buy health insurance, especially if they are well. Unfortunately for many of the insurance companies, healthy people did not purchase insurance despite penalties, so many of these insurance companies had to opt out of the exchanges because they lost money.
  • The ACA was supposed to reduce costs overall. Obviously it wasn't going to cost less to get healthcare for many more people, but the overall trend was supposed to go in the right direction. This document from the Center for Medicare Services is interesting. Healthcare expenses as a percentage of our gross domestic product went up, from 17.4% in 2014 to 17.8% in 2015. In 2015 we spent a staggering $9990 per person on healthcare. The congressional budget office predicted an overall reduction in costs. Perhaps it just needed more time.
  • The government assured the insurance companies that it would pay them for any losses under the new plan. The total cost of this was expected to be minimal since insurance companies that did well would pay a portion of their profits to the program. There were more losses than expected, and the Republican dominated congress refused to fund the difference, leading to what was essentially a breach of contract. The stiffed insurance companies are now suing the federal government for billions of dollars. It turned out that health care cooperatives, which were a great idea, had the biggest trouble staying afloat and so the vast majority of those have folded.
  • More patients can now receive healthcare, 20 million or more, but out of pocket expenses and the price of insurance is rising. Before subsidies, health insurance premiums will rise 25% in 2017. Premiums reached over $18,000 for an average family in 2016, though most families still were able to buy affordable policies through the exchanges because of subsidies. 
  • People receiving health insurance through their employers are spending increasing portions of their salaries for their share of health insurance premiums, now over 10%.  Employers pay the majority of these premiums, leading to lower profits and lower worker salaries. This is a continuation of a trend that was present before the ACA passed, but the situation has not improved.
  • Twenty-nine million people are still uninsured. Nineteen states have refused to expand Medicaid. This leaves patients who are too poor to afford health insurance but not poor enough to qualify for regular Medicaid with no health insurance. These people get medical care only in extreme circumstances or pay for expensive care themselves, leading to financial destitution and unpaid bills which hospitals or clinics have to absorb.
  • Some of the experiments to improve quality and reduce costs have introduced layers of complexity to doctors' already complex jobs and this leaves them with less time to spend with patients and with more job dissatisfaction. Physician burnout is increasing, now at over 50%, primarily attributed to administrative duties.
Could the ACA be better?
Yes, for sure. There were many compromises leading up to passage of the bill, despite the fact that in the end it passed without any Republican support. Progressives pushed for a single payer system which would make the federal government the major provider of healthcare coverage. (Actually, in terms of dollars spent, the federal government is the major provider of healthcare coverage.) This could have been done as an expansion of Medicare which is already an established and relatively frugal insurance plan. The government would then have been in competition with the health insurance industry which did not make their very powerful lobby happy, and some physicians balked, expecting a heavy handed approach to what they were allowed to do for their patients. A "public option" was also put forward, which could have provided an optional government funded insurance, but that, too was seen as competing with private insurers and might have become yet another very expensive and possibly budget busting entitlement program. The ACA legislated the creation of the Center for Medicare and Medicaid Innovation to help come up with creative ways to provide and pay for healthcare, but prevented them from using cost-effectiveness analysis to decide what to recommend. This was because of concerns about "rationing" healthcare. The ACA in its original form required the states to expand Medicaid, with the federal government footing all of that cost for 2 years and then gradually reducing that subsidy to 90% by 2020. The Supreme Court found that requirement to be unconstitutional, leaving 19 states to make a short sighted decision to forego a significant subsidy from the federal government and leave a proportion of their poorer citizens without healthcare coverage.

So the ACA could be better by being bigger. It could have entirely revamped how healthcare was paid for by introducing a single payer or provided a good public option. This would not have passed congress and certainly won't now. It might have been great eventually, but would have been very expensive and might have destabilized the economy. The ACA could have explicitly recommended we reduce costs by looking at value and eliminating services with low value. It could have offered expanded Medicaid without state support, leading to more nearly universal health coverage.

It could have been better by having bipartisan support, but, having watched the whole process go down, it's not clear how that could have happened. The idea of universal coverage with an individual mandate was taken straight from various Republican proposals over the last 15 years, and looked very much like the Massachusetts health plan sponsored by Mitt Romney. The ACA did not fund abortion and did not extend Medicaid to illegal immigrants. It provided a waiver for patients based on religious beliefs. There was no funding for talking about end of life wishes with patients due to concern that this might mean we had created "death panels" to decide who would live or die. Still, there was no Republican support for what was very appeasing legislation.

It could have been better by being smaller. Many of the exclusions and exciting new programs which were introduced to make it attractive to legislators also made it hard to understand. Patients to this day have very little idea what the ACA is or even that it is the same thing as what they call Obamacare. Physicians are unclear about its provisions and blame various woes on the ACA that belong to different legislation or to developments not related to law at all.

What will happen to it?
Members of the present administration have vowed to repeal it, but want to hold on to some of the most popular provisions. I have gleaned from many reliable sources that:

  • They would like to make health insurance companies continue to insure people regardless of pre-existing conditions so long as they maintain continuous healthcare coverage. They also want to allow children to stay on their parents' health plans until age 26. 
  • They do not want to continue to subsidize the expansion of Medicaid or subsidize insurance for people based on income. They would consider a refundable tax credit to help pay for insurance.
  • They would like to limit the federal government's funding of Medicaid. Presently the federal government pays a percentage of each state's costs for Medicaid and has significant control over how that money is spent. The Republicans in power favor "block grants" for Medicaid which would provide a fixed amount of money for the program to each state, to be spent as the state decides. This could lead to appropriate economies, but could also lead to states running out of money for programs and cutting funding to vulnerable people. 
  • There has been a proposal to reform malpractice at the federal level, primarily capping what a plaintiff can receive for non-economic damages. This would save money, in theory, by encouraging physicians not to order excessive tests just to avoid being sued. Thirty states have already passed such legislation and some evidence does point to a reduction in healthcare costs.
  • Health Savings Accounts (HSA) would play a part in paying for care, allowing patients to use pre-tax dollars for health expenses. Unfortunately most of the people who have bought insurance through the exchanges are not wealthy and have been subsidized, and so don't have money to put into HSA's.
  • It is unclear what the administration intends to do with regulations on the insurance industry. If they require that insurance companies insure patients with pre-existing conditions who will likely be more expensive, but repeal the individual mandate as they have promised to do, insurance companies might well fail. Patients have become used to getting preventative care without having to pay a deductible, but it is unclear that this is cost saving, so without legislation to require coverage insurance companies may do away with this provision. This is likely to make constituents very unhappy. I have not heard anything about caps on out of pocket expenses or lifetime expenditures. 
  • There is an intention to allow insurance companies to sell their products across state lines, improving competition and therefore reducing costs. This may help, but patients may find that their cheaper out of state insurance doesn't pay for their local doctor or pharmacy or that it lacks protections they had come to rely on.

Bottom line
There is a good chance that the "Obamacare" that we are just getting used to will go away. This will be "the beginning of an uncertain and tumultuous chapter in U.S. health policy" per Jonathan Oberlander, a professor at University of North Carolina and the author of The Political Life of Medicare, in an article in a recent issue of the New England Journal of Medicine. The ACA has been divisive and irksome to Republicans for years and they would have repealed it already if they had had the political muscle they do now. It will be tremendously difficult to deal with the aftermath of that, especially the 20 million people whose access to healthcare will be endangered or lost. None of the ideas that have been mentioned so far come close to managing this. In order to provide access to care that constituents demand at a price that taxpayers can tolerate, compromises will need to be made. The work of improving cost efficiency in medical care, pharmaceuticals and in payment models will need to become a non-partisan issue.

*As a person in need of healthcare, it may be wise to sign up for health insurance through the marketplace before the January 31 deadline, if you are not already insured. The future of these insurance policies is unclear, but it is unlikely that any change in the ACA will affect insurance that a person has already purchased, at least in the short term.

Thursday, January 19, 2017

Conflict of Interest in Medicine--Why should we care?

This weeks issue if the JAMA (Journal of the American Medical Association) reads like an expose. At least 3 of the research articles do. So exciting. I don't want medicine, my field, to be ethically unsavory, but it is sometimes. It makes me proud to see that it sometimes polices itself and that such information is published in a high profile journal.

The first article is entitled "Patient Advocacy Organizations, Industry Funding and Conflict of Interest" by Susanna Rose of the Cleveland Clinic along with colleagues of hers from the University of Chicago. It turns out that 67% of  patient advocacy organizations such as the American Diabetic Association, the Multiple Sclerosis Foundation and March of Dimes, organizations that support patients with various diseases, receive support from industry. Specifically "industry" means organizations that make money by selling products related to health. More than one in 10 of these organizations received over half of their support from industry. Nearly 8% of the leaders of advocacy groups surveyed admitted to feeling pressure to conform to the wishes of their corporate donors. Since this is a hard thing to admit, that number probably vastly underestimates the true impact.

The Institute of Medicine has written extensively on conflicts of interest and how to manage them. Financial conflict of interest occurs when the primary aim of an organization, in this case to advocate for patients' best interests, is in competition with a secondary goal such as promoting a product for a company that pays your bills. It is hard to quantify just how these conflicts of interest play out. Big drug and device companies have tremendous amounts of money, expertise and resources to strengthen an organization, but they also are primarily motivated by making money. If they wish to sell a product that is of questionable benefit to patients, an advocacy organization could be a powerful ally in marketing. Patients think of their advocacy organizations as representing their interests, sometimes in opposition to the medical establishments. There are no disclaimers for them to read such as "this organization supported by the makers of patented titanium bone screwdrivers or magic diabetes-be-gone pills."

The next article by Dora Lin and colleagues from The Johns Hopkins School of Public Health looked at the organizations and individuals who argued with the US Centers for Disease Control's (CDC) guidelines for prescribing opioid pain medication for chronic pain. Unless you have lived under a rock, you have probably observed that prescriptions for pain medication in the opiate class increased dramatically for several years, followed by all of us noticing that there was increasing numbers of patients addicted and also dying of overdose. In response to this problem healthcare advisory groups have recommended prescribing these drugs less often, at lower doses and discontinuing them sooner along with offering non-opiate options for pain control that are less dangerous and probably more effective. When the CDC's recommendations came out there were criticisms and so there was a period of invited comment before the final release. It turns out that the majority of criticisms came from organizations with ties to opiate manufacturers and none of them mentioned this in their comments. There are many reasons for the US opiate epidemic, but misinformation propagated by the pharmaceutical industry was definitely an important one.

The third article was even more concerning from a financial standpoint. In the last few years we have seen major changes in the way we treat hepatitis C and elevated cholesterol levels. Guidelines released in 2013 by the American Heart Association recommended that we extend the number of people who will be treated with cholesterol lowering "statin" drugs to anyone with a 10 year risk of atherosclerotic cardiovascular disease (heart attacks and the like) of over 7.5%. Guidelines released in 2015 for the treatment of hepatitis C, a chronic liver disease caused by a blood borne virus, suggested that we treat everyone with hepatitis C with extremely expensive drugs which, kudos to pharmaceutical researchers, can cure the disease.

The price tag is the reason that this last article (by Akilah Jefferson and Steven Pearson of the National Institute of Health and the Institute for Clinical and Economic Review) is of greatest concern. Statin drugs, which are definitely good for some people, especially those with known heart disease, are set to reach over $1 trillion in worldwide sales by 2020. The new hepatitis C drugs can run over $1000 a pill, or $80,000 and up for a treatment course and will account for about 10 billion dollars of healthcare spending in 2015. It turns out that a significant number of physicians in both of the groups who were responsible for developing these guidelines had support from the manufacturers of the drugs they directed to be used so extensively. The Institute of Medicine made some pretty clear recommendations about conflicts of interest in 2009 and neither of the organizations responsible for producing these very influential guidelines followed these recommendations.

So it's good that we are talking about this but not good that it is happening. The problem with conflicts of interest isn't that they necessarily lead to bad decisions, but that they probably do and that we don't know. We as physicians try to do good, and we've been told in the last many years that we can do the best for our patients by following guidelines. These guidelines, we are led to believe, are based on the best of scientific evidence and, lacking the time to read all of the literature and keep up with the astounding amount of new data that comes out every year, we would do well to follow them. But if the people who create the guidelines work for the companies that stand to benefit financially from the outcomes of those guidelines, we would do better to question them. At the level of populations, the decision to recommend that all patients receive a treatment rather than a smaller group of patients who would more clearly benefit makes a huge difference. Our individual budgets as well as our nation's budget for healthcare are limited. A choice to use an expensive medication is also a choice not to do something else that might benefit us more.

Conflicts of interest are common and part of the human condition. It is not possible to entirely eliminate them in any situation. In cases such as guideline development and patient advocacy groups in which patients are vulnerable to influences which do not have their best interests as a guiding force, we should be especially sensitive. Physicians should try hard to recuse themselves from making important decisions in which they have a conflict of interest. We should honestly recognize that bias in the form of industry connections may make it impossible to be truly objective.

Friday, January 6, 2017

The 21st Century Cures Act--allowing drug companies to speed up development of drugs that may not work

Early in December Congress came together in bipartisan support of HR 6, the "20th Century Cures Act." So unusual, these days, for a "landmark bill" to pass into law without major objections by Democrats or Republicans. Perhaps something fishy was going on. Perhaps this was a chance to please special interests while making the average voter feel that, at last, congress was going to accomplish something good.

The bill was hailed as supporting the development of new drugs and devices to cure dread diseases by reducing unnecessary regulation by the Food and Drug Administration. I found the text. It is amazingly difficult to read. The legal terminology is nearly impenetrable and the actual content is pretty hard to discern. It is also full of barely related measures, some of them excellent and some of them likely to have nasty consequences. I am particularly wary of the provision that encourages use of digital medical imaging by paying less and less for tests done with older x-ray machines, the one that allows pharmaceutical companies to pay for doctors' continuing medical education and the one that excludes approved generics from calculations of average manufacturers' price for drugs. I am perplexed by the creation of a 14 person working group specifically to address Lyme disease and other tick-borne diseases.

An excellent commentary by Aaron Kesselheim MD, a primary care physician with a law degree and special expertise in the ethics of pharmaceutical research and sales, discussed the many problems with this legislation. He is particularly concerned that the shift toward haste in approving new drugs will lead to new and expensive drugs that will enter the marketplace without convincing proof that they actually work. The FDA, at its inception, was instrumental in reducing the number of quack medicines on the market and inspiring trust in newly invented products. The bill will encourage the use of data which may be less accurate than what is presently required.

We do need more and better drugs to treat the conditions that make us miserable and shorten our lives. The US has been at the forefront of the world as an inventor of innovative products that save lives, though often at astronomical prices. The US was responsible for developing anti-viral medication that has allowed us to actually cure hepatitis C, a disease that often leads to endstage liver disease. The drug manufacturers charge $40,000 for a course of these medications, and many of those who have the disease are either uninsured or underinsured. We have come up with cancer chemotherapies that are less toxic and make metastatic cancer, which was once a death sentence, into a treatable disease, but they are oh so expensive. We have also made some terrible drugs. We have produced drugs for high blood pressure that don't reduce the risks associated with it, drugs for pain that have been pushed to the extent that huge numbers of Americans have become addicted, medication for bladder urgency that makes the mouth dry, but barely changes a person's urgency or incontinence. We have produced injectable medication for cholesterol which does reduce serum levels, but is not yet known to save lives or improve health. This can cost over $10,000 per year. I don't think we want to allow pharmaceutical companies to enforce their own ethical standards.

The bill was also roundly praised for a provision that was supposed to fight the opiate epidemic. Again, I find the text of the bill to be difficult to understand, but it appears to be pretty anemic. From what I can glean, it allows insurance companies to cut off payment for drugs of addiction to patients who are felt to be at high risk of prescription drug abuse. In addition these people must receive information on drug and mental health treatment programs which are federally funded. It does not have to actually provide this treatment. Dr. Kesselheim says there is money for grants to the states to reduce opioid abuse and to reorganize mental health care delivery, but I found nothing like that in the text of the bill.

The bill does provide better funding for the FDA, which is good, because with sequesters and budget cuts, the financial support for funding research through this agency actually went down 22% from 2004 through 2015, according to Dr. Kesselheim. The costs of this program will be paid for by selling off some of the US petroleum reserves and from cuts in the prevention and public health fund of the Affordable Care act. That doesn't sound like a good choice.

Overall, it is not clear that the Cures act actually cures anything. It will increase funding to the FDA and may streamline approval for innovations, but we will be less sure that those innovations are really useful. Congress may have passed legislation that gives drug and device manufacturers a pass to make products that are painfully expensive and may not work.