Growth, Progress, Drugs, and Health Care: All in pursuit of profit

There are times that I worry that I might come across as a Luddite, opposed to new drugs, new technology, progress and change, because I am often critical about how these changes are happening, and also frequently have dampened enthusiasm and expectation for the probability that they will be successful in achieving their stated goals. For the record, I am not against either change or progress, although the definition of “progress” is a loaded one; progress is only good to the extent that it makes people’s lives better. Of course, if it does not it can still be considered “change”, but may well be regress.  Here I exhibit my values: it has to make people’s lives better, and not just those of a few people, but essentially everyone.

I have recently been re-reading John Nichols’ novel “The Magic Journey”, originally published in 1978. While Nichols’ most well-known book is probably “The Milagro Beanfield War”, published in 1974 and made into a film with Ruben Blades in 1988, “The Magic Journey” is his magnum opus. It documents the transformation of Chamisaville, a fictional town that is a thinly-disguised Taos, from a 400-year old subsistence agrarian economy with little cash changing hands, to a “modern” town. A major way this occurs is through the hiring of young people to build things, paying them salaries, allowing them to buy stuff, going into debt, and selling off their families’ land. It is a bit more complex than that, because the “Anglo Axis” controlling this change does far more direct and clearly evil things to move the process along, but the change, the progress (as it were), occurs. It both changes and does not change the life of the people who live there. Yes, they (or many of them) may now have cars and refrigerators and central heating (and the debt that goes with it), but they mostly all still remain poor, and on the edge of desperately poor, often teetering and sometimes falling. Meanwhile, the positive joys of their lives, the music and singing and storytelling and culture fade with each generation, except those that are commercialized for sale to tourists. The Anglo Axis does well, of course, and the one consistency in their decision making is how to make more money and, in order to continue to do so, cement their control and hold on power at every level.

The story of Chamisaville is a story of capitalism – of its triumphs, bringing progress, and its dark, dark side, institutionalizing a continuing oppression and repression. And, in this, it is a microcosm of the US, and much of the world. The health care industry is a big part of that world, and it is run by the same folks for the same reasons. To wit: make as much money as possible, regardless of who (else) gets hurt. And to press forward with the marketing campaign – health is good for you, right? – so that those who control it continue to make money. In capitalism, certainly US capitalism, “progress” is one of the two most commonly used vector words, along with “growth”. Both, the story goes, imply “better”, but this is not always the case.

We know – or should know by now – that “growth” can be terribly bad. With 7 billion people on the planet, most of them in desperate poverty we also have desperate inequality (in India, for example 9 people have as much wealth as the bottom 50% of the population – that’s 600,000,000 people!), we have limited resources. And we spend an enormous percentage of them on war, which continues to compete with the climate crisis generated by our dependence on fossil fuels to see which will be the first to wipe out life on earth, not just our health. The mantra that growth will solve all our problems is not only wrong, it is by now backward.

Yet, in health care, we continue to strive to make progress, and it is not always bad. But one does not have to be a Luddite to note the risks and contradictions. Novartis has just released a new gene therapy, Zolgesma® that treats spinal muscular atrophy, a terrible genetic disease. That is a good thing. But it costs $2.1 million. That is an unbelievable thing. Should it be made available to the children who need it? Yes. Who pays? Not the individuals (unless they are at least multi-millionaires). The insurers? Yes, but then it gets spread to all those with that insurance. The society? Like a national health insurance plan? Sure, but who decides that Novartis should get $2 million for it? This is a big deal. It isn’t that children with this disease should not be treated, but it is the fact that LOTS and LOTS of other people with more prosaic diseases could be treated for that money.

How to allocate resources will always be a difficult decision for health care. More for lower cost services that benefit more people or more for higher cost services than are critical to a few is an ongoing decision made in nations throughout the world because all resources are limited. However, a few things are clear (to me) that should guide these decisions. The benefit of the many should take precedence over the benefit of the few, even if the few are very rich (and I am not saying that the families of SMA children are). This is easy to say, but becomes more difficult when the benefit to the few is great and the benefit to the many is smaller. Or when you are one of the few. Quality of life is important; in the US and some other rich countries, enormous amounts are spent on high-technology care at the end of life. Yes, sometimes it is difficult to know when the end of life will be exactly, but it is often clear that what is being done is protracting existence without quality or hope of improvement. And, in this context, huge profits for the drug manufacturers is not something that should be built into the equation.

It is not only end-of-life care that skews high-technology. Investment in whiz-bang stuff is always, somehow, sexier than providing the care that we already know how to do, already is relatively cost effective, and is not brand new. We need to keep this in mind as we develop, invest in, propagate, and utilize new technologies. Luke Miner’s Op-Ed piece in the New York Times, ”For a longer, healthier life, share your data” argues that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) too extensively restricts data sharing among providers and especially to researchers, who could use this “big data” to identify epidemiologic patterns and link them to genetic profiles within populations, enhancing  both the likelihood of diagnosis and the opportunity to develop treatments. In addition to HIPAA, his big emphasis is on artificial intelligence (AI), and how it could compile and sift through this data to achieve results never before possible. He suggests that, as long as HIPAA prevents sharing this data without your permission, that you give your permission.

This is not necessarily a bad idea, but can never be divorced from the MOST core concept: Who will control that data, and perhaps even more important, who will PROFIT from it. The evidence is absolutely clear: there is nothing so destructive, so evil, so heinous that some people will not do if it makes them enough money. This is lesson #1.

Lesson #2 is that before, or at least while, we invest billions in genetic drugs, personalized medicine, artificial intelligence, high-tech gizmos that will help some people, or maybe (no guarantee!) in some future help a lot of people, we have to be able to disseminate the well-know and cost-effective treatments that we have. Millions die daily from preventable (see: vaccines) or conditions treatable with things we have available to us.

The real magic, the real whiz-bang, the real excitement, will be in ensuring the widest possible implementation of what we already have to care for all the people who need it.

Gangster capitalism and our health: In the US and in the World

There has been a lot written about capitalism. Karl Marx, for example, wrote a multi-volume study of it just about 150 years ago, and since then a lot of the writing has been about what he wrote, supportive and critical. There is no question that it has remained the dominant economic system in the world; it is the linchpin not only of Western “democracies” and totalitarian fascist states but also ostensibly Marxist governments like China. While capitalism has both its defenders and detractors, it is interesting to me that the defenders spend little time defending the amazingly deleterious effects that it has on the quality of life (and even existence of life!) of people, the environment, war, and (to the point of this blog) health.

The problem is that, in pursuit of profit, industries will do and have done almost anything, with no moral compass or conscience, and, worse, with no concern for future generations or the planet. Some of the most obvious and egregious examples in the US at this time include their (largely successful) lobbying of the current administration to roll back on rules to ensure clean air and water and the overall environment so that they (in this case, extraction industries like oil and mining) can further increase their unconscionable profits without worrying about the damage it does. So we have mining and extraction in and near our national parks (“near” is important; air and water do not respect boundaries!), scaling back of national monuments so extraction can take place, poisoning of the water through leaks in oil pipelines (such as Keystone), and poisoning of the air we breathe when fossil fuels are burned. Oh yeah, and the increase in global warming which has already permanently altered the climate and will eventually wipe out life on earth (starting with the lowest lying areas) if nuclear war doesn’t first.

Our health and safety is also constantly at risk from aggressive efforts by corporations to increase their profits. This can take the form of producing unsafe products either because it saves money (e.g., dangerous child toys) or costs a lot to not do (e.g., not having lead in our water or asbestos in talcum powder), or by making important and beneficial (and hopefully safe) medications unavailable to many people because of incredible price increases (for the tip of the iceberg, see “Epi-Pen® and Predatory Pricing: You thought our health system was designed for people’s health?, September 3, 2016). We of course know about the ongoing – and largely successful efforts – of the tobacco industry to increase their profits by promoting a product that kills 400,000 people a year in just the US (mainly from cancer and heart disease), including through promoting it to children (e.g., the cartoon character “Joe Camel” – see Fischer et al, “Brand Logo Recognition by Children Aged 3 to 6 Years: Mickey Mouse and Old Joe the Camel”, JAMA 1991;266(22):3145-3148, December 11, 1991).

One of the most vicious and insidious efforts to compromise our health in the interest of profit has been carried on for more than a half-century by the sugar industry. For decades, under the table, sugar producers funded scientific research into the negative effects of a high-fat diet while ignoring the almost-certainly more detrimental effects of a high-carbohydrate, especially simple carbohydrate – sugar – based diet. Soda pop became the national beverage with incredible impact on the rate of obesity, in the US and internationally. A 12-oz can of Coca-Cola® has 140 calories, so what about that 40oz fountain drink at the convenience store? A 2-liter bottle has 812 calories. That’s a lot. So most health professionals, like doctors, tell people to not drink it, or not very much of it. This is, however, competing against the messaging of the industry, which pushes it a lot, and gets the cooperation of many nutritionists through the use of – wait for it – money! I have written about the corruption (or conflict of interest, to put it nicely) of health organizations like the American Academy of Dietetics and Nutrition (AADN) and the American Academy of Family Physicians being funded by Coca-Cola® and other sugar purveyors and having their ads on their websites (The AAFP, Coca-Cola, and Ethics: Serving the public interest?, August 20, 2010). The ads are no longer there, but you can read about the AADN at the fooducate blog, and if you search sugar on the current AADN website, you will find some pieces on limiting sugar, but as many on the potential risks of artificial sweeteners (which, whatever your beliefs,  the FDA rules as safe) and fats.

Of course, as with the case of tobacco, efforts to limit the sugar market in the US (such as Mayor Michael Bloomberg’s failed attempt to limit the size of sugary sodas in NYC), have led the industry to branch out and increase its efforts to profit in the rest of the world, particularly the developing world. While many countries can be targeted, the biggest markets, China, India, and Mexico, have received special attention. The NY Times has an important exposé  on January 9, 2019, ‘Research details how junk food companies influence China’s nutrition policy”, citing work published in BMJ (“Making China safe for Coke: how Coca-Cola shaped obesity science and policy in China”) and the Journal of Public Health Policy (“Soda industry influence on obesity science and policy in China”) on the role of the International Life Sciences Institute (ILSI):

…a worldwide organization with a Washington headquarters, funded by many of the biggest names in snack foods, including Nestlé, McDonald’s, Pepsi Co. and Yum! Brands as well as Coca-Cola. It has 17 branches, most of them in emerging economies like Mexico, India, South Africa and Brazil, and promotes itself as a bridge between scientists, government officials and multinational food companies.

But in China ILSI is so well-placed that it runs its operations from inside the government’s Centre for Disease Control and Prevention in Beijing. In fact, when asked to comment on the studies, the ministry emailed a statement not from a government official but from ILSI’s China director.

Thus China’s health policy, which almost entirely focuses on exercise like “Happy 10 minutes” (good for you!) and ignores the dangers of high-calorie sugar-laden foods for obesity (and there is excellent evidence that diet is probably about 80% of the issue, with exercise critical for the other 20%).

There are those who will argue that it is not capitalism itself, but “unfettered capitalism” that is the problem. There is a lot of truth to that. The blind pursuit of maximal profit with no attention at all to the negative impacts on the world around them is not a necessary part of any profit making endeavor. Indeed, the “Wealth of Nations” by Adam Smith cautions strongly against this sort of excess, and “the only responsibility of business is to make profit for its stockholders” guru Milton Friedman sort of assumed that they wouldn’t do it.

But they do, and “unfettered” – or corporate gangster capitalism – is what is running the world. And it is not good for our health.

The Administration closes the National Guideline Clearinghouse: Bad for our health!

The Department of Health and Human Services (HHS) has closed the National Guideline Clearinghouse (NGC), which was housed in its Agency for Health Research and Quality (AHRQ), by pulling its funding. If one goes to the NGC website, it actually says that there is no longer funding for it. The NGC provided a major resource for consensus information, and closing it is a tremendous loss, not only for the physicians and other medical providers who depended upon its recommendations, but for the health of the American people. It is also, sadly, a loss for the patients of physicians and other medical providers who did not heed, and even opposed the existence of these guidelines. This is because  they will now have the cover that comes from the absence of the NGC when they do things that are not supported by the best evidence available.

Wait, wouldn’t my doctor want to use the best evidence available? Can’t I depend on her/him doing this? Do I have to become a medical expert?

You – we would all – hope that our doctors would use the best evidence available. This is not necessarily the newest stuff, for the obvious reason that it is new, and thus less tested. Frequently, when a test or intervention is new, it looks good, but later, when more people have been exposed to it and more data are available, negative information may emerge. (Sometimes this is because serious side effects may appear to a new drug because so many more people are using it; sometimes it is the result of straight-up fraud, as in the case of Theranos – see The Political is Personal: Corporate power, social isolation, and the health of the nation -- Part 2, April 22, 2018.) Conversely, the oldest tests and treatments are not necessarily the best either – a doctor who does not keep up after his or her training is also going to be way behind.

And guidelines are, of course, guidelines, not laws – they are meant to guide the practitioner to help make the best decisions by summarizing and presenting the evidence, for the whole population and for significant “sub”-populations. For example, older people may have a greater benefit from – or be at greater risk of harm from – a certain treatment than younger people. This could be from a different physiology (kidneys, for example, don’t function as well at cleaning out poisons in older people) or from a different risk/benefit profile (perhaps a bad outcome usually takes longer to appear than the life expectancy of a person; a 20-year lag time for something bad has a different meaning for a 50 year old than an 80 year old).

Not all guidelines have the same strength of evidence behind them. Sometimes the evidence is very strong, coming from multiple randomized controlled trials (RCTs) that are consistent with each other; at the other extreme, they can come from the opinions of a group of experts in the field who are gathered for the purpose of creating a guideline. However, in any case, the guidelines presented should be those for which the strongest evidence exists. The website for NGC still has available the inclusion criteria for the guidelines that used to exist there. The physician is always able to do something different if the recommendation is for some (good) reason not appropriate for a particular patient. But s/he should know, or be able to find – on the NGC, say – what the guidelines are for a particular course of action (test, treatment, etc.). Until just recently, they could. Not now. Which raises the question: why is it gone?

I, of course, do not know the answer, so am forced to speculate. There is some cost to maintaining the guidelines and doing the research, and many people do not like cost, but so much more is being spent on arguably less important things (if one considers the health of the people important; I do). Some people, versions of libertarians, do not like anything that even suggests government mandates, but I know few libertarians who advocate suppressing the truth. Some people are not surprised at any actions taken by the current administration and its executive departments, particularly those that seem to take on science, as has happened with climate change and the use of fossil fuels, but those seem, ultimately, to be based on money and the opportunity for profit. Thus, destroying pristine areas for fossil fuel exploration (the Arctic, the tar sands) and transport (the Keystone pipeline), as well as of the world’s climate from burning them, makes people money. Rich and powerful people.

So maybe that is where we should look for the closure of NGC. The fact is that if there are guidelines there is a rebuttable presumption that, barring differences in the individual patient that are relevant, they should be followed. If the evidence shows that a particular diagnostic test or a treatment (drug, device, etc.) is usually better, it is going to hurt the pocketbooks of the manufacturers of alternative drugs or devices or tests. And it can also hurt the pocketbooks of actual doctors if they make their money doing something that is no more effective than, or even less effective than, doing something cheaper or easier – especially if that is done by someone else. Sometimes the issue is standardization; it saves money for a hospital (and can improve quality) if only one or two types of, say, artificial joints are used. But this hurts (obviously) the manufacturers of the other brands, and perhaps is a negative for those surgeons who have learned how to use the non-preferred brands (see Atul Gawande, “Big Med”, New Yorker, August 13, 2012). It is even a bigger issue when the evidence demonstrates that the costly surgical option doesn’t work, or doesn’t work as well as, a much cheaper non-surgical option that exists. Well, then, you are threatening someone’s income – just like renewable energy threatens the income of companies that produce and sell fossil fuels.

But would doctors actually do such a thing? Resist a cheaper and more effective alternative because it would cost them money? You betcha. Not always, of course, and not all doctors, but it has happened. “In the late 1990s,” the New York Times observes in its excellent editorial on the subject,  “when it [AHRQ] endorsed nonsurgical interventions for back pain, the back surgeon lobby waged an attack that resulted in huge funding cuts and placed a permanent target on the Agency for Healthcare Research and Quality (A.H.R.Q.), the agency that houses the database.”[1]They attacked the existence of the Agency because they didn’t like (REALLY didn’t like, since it would hit them in the pocketbook!) the evidence.

Yup. It happened. I remember it. It was shocking to me (I must have been more naïve!). I lived in San Antonio at the time, and a San Antonio congressman, Henry Bonilla, was leading the charge against AHRQ, to the embarrassment of the non-back-surgeon San Antonio medical community. But they were, and are, a rich and powerful lobby. And they are still doing thousands of surgical interventions for back pain of the type that AHRQ recommended against in the ‘90s. And making a lot of money on it. Maybe you had such a procedure? Did it help? I hope so. If you are trying to decide, for this or any other complicated treatment (surgery, cancer treatment, etc.) and wanted to know what was recommended for your problem, you could have gone to the NGC website and looked it up. Not now.

One issue with the evidence, of course, is that it depends upon what research was done, and on what populations. And diagnostic and treatment plans that make money for doctors and hospitals are only of use to them if they get paid, and paid well, so they are less likely to be done to poor and uninsured or underinsured people. Maybe this is one time when not having good insurance is a health benefit!

But it shouldn’t be. We should all be covered for necessary diagnosis and treatment. And whether providers or manufacturers can make money should not be a criterion for recommending it. And now we have less access to finding out what the recommendations are.

---

[1]By the way, how did Fox News cover this story? I could only find one link, to Fox Vegas, which used the CNN coverage, which was quite critical of the elimination of NGC. National Fox didn’t seem to think it worth covering.

Precision medicine, trade policy and the cost of drugs: benefiting people or profit for business?

In a recent (January 29, 2015) New York Times Op-Ed, Mayo Clinic anesthesiologist Michael Joyner writes that “’Moonshot’ medicine will let us down”. What Dr. Joyner is referring to is what is now most commonly called, particularly in the large academic medical centers that have bought into it in a big way, “precision medicine” or occasionally “personalized medicine”. This is the concept that, by knowing your individual genetics, medicine can devise targeted treatments for diseases (most of the emphasis is on cancer) that will work for you, but maybe not for other people. Maybe the treatment most commonly used for the disease isn’t right for you; this would find it out.

It is a very attractive concept, and one that has clearly gained traction since the first complete sequencing of the human genome in 2003, moving from a science fiction idea to a mainstream investment by many institutions. As Dr. Joyner notes, “President Obama’s new budget is expected to include hundreds of millions of dollars for so-called precision medicine. The initiative, which he introduced last week in his State of the Union address, has bipartisan support and is a bright spot in the otherwise tight funding environment for medical research.” That is the “moonshot” part – hundreds of millions of dollars. When other funding for research is stagnant or being cut. Because it sounds cool, exciting, really like something cutting edge, a step toward the day when disease will no longer bedevil the human race. However, Dr. Joyner adds: “Unfortunately, precision medicine is unlikely to make most of us healthier.” Bummer.

Maybe he is wrong. Maybe the medical centers investing heavily in precision medicine, and the federal government which will fund it (of course, the “investing heavily” is not unrelated to the “hundreds of millions in federal funding) are right. “Star Trek” here we come! But let us look at the evidence that Dr. Joyner presents. He notes that most common diseases that affect people, even those with clear association with families and thus likely genetics, such as Type II diabetes, are not the result of a single or even a few genes that could be targeted if they could be fixed. There are multiple genetic characteristics that impact whether someone has a tendency to get DM2. Moreover, whether it actually occurs is a result of a complex interplay between those genetic risks and actual behaviors such as diet and exercise. He argues that it is obesity, caused by behaviors but certainly abetted by social changes in our lives, jobs, and easily availability of cheap high-calorie food leading to obesity, that has been the major culprit, given that DM2 (and obesity) is an epidemic of the last half-century, therefore not a result of any genetic change. In addition, even when there are genetic factors for differences between people in their response to treatment, it turns out that these do not explain most of the difference (“missing heritability”), such as in response to the anticoagulant warfarin (a so-far failed effort to use precision medicine to choose treatment). Treatment of chronic diseases like cystic fibrosis by genetic intervention has been unsuccessful, and cancer (like microbes) mutates a lot faster than genetically normal cells.

Joyner also raises the very real concern that people’s behaviors will change in ways that work against their health when they learn their genetic risk. Some people will use the information that they are at lower genetic risk to adopt risky behaviors. This has been described in many areas, everything from people with negative cardiac tests continuing to smoke and overeat to men who have had negative HIV tests and circumcision to decrease their risk of spreading HIV increasing their unsafe sex practices. He also notes that the opposite test result, finding yourself to be at greater genetic risk, can also lead to unsafe practices because you figure you’re doomed anyway. In addition, he notes that there are some people (“worriers”), “…who might embark on a course of excessive tests and biopsies ‘just in case.’ In a medical system already marked by the overuse of diagnostic tests and procedures, this could lead to even more wasteful spending.”

The main message here is only in part that “precision medicine” is something whose time has not yet come and may or may not ever come. More important thing is that, despite this, the government is planning to invest hundreds of millions of dollars in it. Most important is that money is not being spent on implementing treatments for conditions that we do know how to treat. People who are poor or uninsured cannot access many already available – and often incredibly expensive – treatments for diseases like cancer (see my piece “Squeezing the needy: a truly flawed financing system for healthcare”, March 2, 2013) or hepatitis C or many neurologic diseases. “Precision medicine” treatments are certainly going to be even more costly. In addition, we do not spend the necessary money to address the social determinants of health--housing and food and warmth and education--that make more of a difference in health than all of health care.

Indeed, we invest large amounts of money, public as well as private, in programs that effectively make our health worse. Sometimes this is in subsidies to major environmental polluters (BP, anyone? How about fracking and the Keystone XL pipeline?), and sometimes it is more direct, when we actually invest government funds in making treatments more expensive and less accessible to people, albeit to the benefit of the drug companies? Noted economist Joseph Stiglitz takes this on in another recent Times Op-Ed, “Don’t trade away our health” (January 30, 2015). He describes how the US Trade Representative, who negotiates trade agreements “supposedly on behalf of the American people”, is in fact consistently working on behalf of big corporations. In the case of the Trans-Pacific Partnership, this will mean increased obstacles to lower-cost generic drugs by making competition more difficult. “Just the availability of generics drives prices down: In generics-friendly India, for example, Gilead Sciences, which makes an effective hepatitis-C drug, recently announced that it would sell the drug for a little more than 1 percent of the $84,000 it charges here.”  This competition should be encouraged; it is the essence of capitalism. But our trade representative is representing big business, not people.

Of course, high drug costs are already a reality. On January 28, 2015, the Times’ Business Section previewed a study coming out in the New England Journal of Medicine from Harvard. “Study finds HIV drugs priced out of reach”. Much of the great advance made against HIV in the last few decades come from effective and more tolerable drug regimens. Atripla, for example, is a once-daily combination of 3 drugs (2 made by Gilead, one by Merck), that is extremely effective. But this study shows that the “flexibility” available to insurers under ACA will mean that folks with worse insurance (usually poorer people) will have to pay $3,000 a year more for Atripla than those with better policies. Again, the poor pay more.

Precision medicine may sound good, and certainly cool, and sexy. It may even benefit some people, if at very high cost, in the future. But right now, today, there are lots of conditions we know how to treat and lots of people who are not getting that treatment because they don’t have the money, are not desirable, have diseases not in the most preferred “product lines”. And we are spending federal money on making some of the drugs that we have that we know are effective less available.

Despite publicity about or funding for precision medicine or any other “new idea”, the fatal flaw is that our health system is not about improving our health, it is about profit. This is intolerable.