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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.

Thursday, December 8, 2016

Drugs for cholesterol and high blood pressure actually can be cheap and work

A couple of weeks ago I started taking medicine to lower my blood pressure and another to reduce my cholesterol. This was a controversial move, given my deep distrust of the practice of medicine, when it is practiced on me, and pharmaceuticals in particular.

I know that, as a woman of 55 with an very active and healthy lifestyle, no chronic diseases and most importantly as a nonsmoker, I am at very low risk for any of the conditions that high blood pressure or high cholesterol could cause to happen. I am unlikely to have a stroke or a heart attack, develop narrowing of the arteries to my legs or develop kidney failure. The blood pressure and cholesterol levels have no effect at all on how healthy I feel. But one day, while pointing an ultrasound probe at my own neck, I saw a small plaque (a thickened area) in my left carotid artery. It was very calcified, which meant that it had been there a long while, but my carotid was not pristine. It is undeniable: I have vascular disease.

Will this lead to a stroke? Does it imply that the arteries around my heart are also affected? I don't know, and I may not find out. But I do know that taking a cholesterol lowering drug helps reduce heart attacks in patients with vascular disease around their hearts and I extrapolate that it may help reduce further changes to my carotid arteries which might lead to a stroke. My blood pressure is a bit high, and bringing blood pressure down does reduce stroke risk. I don't know that it will reduce my stroke risk, however.

So it was not entirely clear that I should take either cholesterol or high blood pressure medication. A little reduction in my very low risk may not be worth taking a medication with potentially profound side effects and associated high costs.

I decided to try the medication in order to assess whether it gave me trouble of any kind. If it did not, I might have nothing to lose. The blood pressure medication, lisinopril, has been on the market for decades. It is strongly associated with reduction in the usual complications of hypertension. Its main side effects are a nasty nagging cough and dizziness. It can also cause life threatening swelling, often of the face, but this is rare. I have had no swelling, no dizziness, and though I can feel just the tiniest bit of increased tickle in my lungs, it is hardly noticeable.

Regarding the cholesterol medication, atorvastatin (formerly known as Lipitor), it, too, has been around for a long time and has been extensively tested and found to be pretty safe and effective. It can cause muscle cramps and weakness, and I have been told by some patients that it makes them less mentally acute. It can cause gastrointestinal upset and may be associated with weight gain and a risk for diabetes. I am having no trouble so far.

As for the cost, I have had to shell out nearly $5 in copays each month, with my insurance footing about $1 of the bill. This is not expensive. This is a superb deal. I get it from my local pharmacist, not even from a mail order or Walmart's $4 plan. It is cheaper than Walmart's $4 plan! In 20 years I will have spent around $1200, plus there will be the occasional blood tests to monitor my kidney function. I checked my cholesterol after being on it shy of 2 weeks, and it was dramatically lower. I, once again, am not sure that this will translate into better health, but it is not odious at all.

The moral of this blog is that not everything is terrible in the US healthcare system. I could, and will, complain about the surrounding process that leads to people like me being on medicine at all, including issues like medicalization of the healthy and blockbuster drugs being widely adopted without adequate scrutiny, but presently I will give generic atorvastatin and lisinopril a big high five.

Friday, November 18, 2016

Presidential Election 2016 and the internet--the real winner

The last year has been difficult to watch, and the last few months even more so. News and quasi-news organizations have been bombarding my email with stories about the people vying for our presidency. It has been anywhere from difficult to completely impossible to screen this information for accuracy. Lies and information taken out of context and repeated until it seems true has been part of both party's rhetoric. The whole field of potential candidates were infected with it before the primary elections.

The emotions have been high, too. By the time the election finally happened on November 8th, we had a comic book villain straight out of the Batman movies running against Satan in female form. The outcome has left people deeply sad and frightened, even people who voted for the winner. There is hope, too, and kindness and gathering together. There is huge uncertainty.

I've been alive for 13 presidential elections, and this one was really different. This is partly because of an increasing gap between rich and poor, fallout of the financial crisis of 2008 and the changing international landscape, but the biggest change has been the growth of our use of the internet and social media.

Most people like to believe that the reason for our recent presidential election results can be found in the thoughts and behaviors of human beings. It feels good, in the face of a frightening and unexpected event to imagine a way that it could have been under our control, that next time we could anticipate it and make significant changes.

As human civilization has evolved, so has our ability to communicate complex ideas. Language, then writing, then printing presses, then telegraph, radio, television and now the internet, links us and allows us to learn from each other and share ideas and feelings and events. With the internet, and now our mobile phones which are ridiculously powerful computers in our pockets, we nearly share a common brain. Even the progressively smaller portion of the population that isn't directly connected via a computer is indirectly connected if they read a newspaper, watch a TV or even talk to a neighbor.

The internet of news is a small part of the entity that is the entire internet. Items that people like to look at rise to the top of any search and appear prominently on Facebook or other sites where people share information. This could be a cute baby dancing, a way to lose weight or a delicious news story, such as a powerful person behaving poorly and getting caught. We will choose to look at these things even if they are out of context, don't work or aren't true, and they will become a larger proportion of what we see. We will be less likely to look at things that are complex, nuanced, and present more than one side of an issue. What we click on is what we get.

There is actually quite a market in made to order "news". Paul Horner was featured in the Washington Post, explaining that the lies he successfully spread via Facebook and other sites around the elections were really just satire and made to be taken as such. But readers believed that people were being recruited and paid $3500 to protest at Donald Trump rallies (he invented this and even created a fake Craigslist advertisement to back it up.) He made money on stories like this, and others such as that the Amish had decided to vote for Trump. Ads on these fake news sites make a good salary for a person with a good imagination. I won't link the stories because that would, in a small way, add to the viral nature of the stories and Paul Horner's livelihood. In fact, by posting a link to the Washington Post article, which links to Paul Horner's stories and his ads, I have contributed to his success, and perhaps the success of fake news in creating misguided popular sentiment.

Humans are amazing. We have created a way to communicate instantly with a group of friends on opposite sides of the earth. But with this we have power to make fiction nearly real, with potentially disastrous consequences. On the medical side of things, I have noticed that the ability to be completely absorbed in communication that requires nothing but small movements of the hands has contributed to an epidemic of diabetes and obesity. Although entertainment that doesn't require the use of resources may be an important aspect of life in a resource stressed world, I don't think we are ready for what we have created. We are more than what we have let ourselves become. We have abilities to connect via touch and smell and eye contact. We care for each other deeply. We have let ourselves become communication nodes made of flesh in a supercomputer which does not have our best interests in mind.

Personally I am being a bit childish about all of this. The internet has let me down. It has sucked up my free time and made my patients fat and has elected people to the country's highest office based at least significantly on information which is not true. I read that we need to take to social media to unite to fight for causes I believe in, and I am questioning that. Facebook is no longer on my phone. I think several times before clicking on links. And I realize that this is a piddly and ineffective response to a problem that is huge and unacceptable. There has been tremendous good that has come out of our ever more powerful abilities to communicate, but presently I am very angry at the internet and I refuse to play.