"Inconvenient truth", science, politics and USPSTF

There are a lot of things that we can expect to be different in a Trump administration, not only than in the Obama administration but even compared to that of G.W. Bush (my previous gold standard for irrational and right-wing policies). Many of these are important, and dangerous, but are arguably political, such as the change in our relationships with other countries (Russia, China, Europe, Israel). However disastrous these policies will be for people in the world (say, Syria) and even possibly destroy the world (nuclear weapons), they proceed from a different political perspective. Also arguably political will be the domestic changes, in the rights of LGBT citizens (such as marriage, use of restrooms), and access to reproductive health services for women, not only abortion but even contraception. The impact on people will be horrific, but it derives from a different perspective (admittedly one that completely devalues huge numbers of people; majorities in the case of women and non-wealthy people).

There will be other changes, however, that proceed from a rejection of science, or of what Al Gore calls “inconvenient truth”. Clearly the biggest one is the one that Mr. Gore was speaking of, global warming, because this will eventually destroy the planet. Maybe later, as we have already been so slow in implementing limits on warming. Maybe sooner, if his climate change deniers have their way. The title of Mr. Gore’s film has several meanings; it is “inconvenient” for all of us to try to find ways to use fossil fuels less rapaciously, but it is a financial issue for others. I am not talking about the coal miners who will lose their jobs; that is going to happen anyway. I am talking about the Captains of Industry, who, unlike the miners, will never be anywhere close to poor but have the possibility of making fewer billions if we seriously address global warming. Oh, the horror!

While of course the destruction of the environment is a health issue, there are also more prosaic health results from those who will try to make policies, or pass legislation, that benefits themselves or their friends and contributors at the expense of truth. Certainly we have seen this regarding reproductive health for years, especially at the state level, where laws restricting women’s access to abortion (targeted regulation of abortion providers, or TRAP, laws) have been based on what might be generously called phony science, or, more correctly, lies. These have included fetal pain syndrome, need for facilities appropriate for major surgery, need for admitting privileges for doctors doing abortions, excessive waiting periods,  and other made-up justifications for doing what legislators really wanted to do – restrict access to abortion. In Florida, a law was passed forbidding doctors from asking their patients if they had a gun in the home, meaning they couldn’t even have a discussion about how to keep them safe from their children accessing them.

So now we have the probability that Congress will be restructuring the membership of the US Preventive Services Task Force (USPSTF) to include more specialists on a body largely made up of primary care doctors and epidemiologists. The goal of the USPSTF is to dispassionately and objectively evaluate the evidence for the effectiveness of tests and procedures aimed at preventing disease. It gives ratings in easy to understand letters (A,B,C,D,I ) that are not based upon the opinions of the task force members but on the actual data. Unfortunately, this doesn’t always make providers happy; if you provide a service (say, mammography for breast cancer screening) on which you make money, then a recommendation that says it doesn’t need to be done quite so often hits you where it hurts – in the pocketbook. So you might come out against it. And while advocacy groups may not have the same direct financial interest (although if you are such an advocacy group, contributions are usually closely related to how serious how many people think a problem is), it may challenge your long-held beliefs. And then, if you find some doctors who agree with you (for example, those whose income may be decreased) you are more confident you were right.

But the goals of USPSTF recommendations is to synthesize the existing data and base their recommendations on that, not to reach “compromise” between those who want something done more (because they are “true believers” and/or have a financial stake in it) and those who believe it is unnecessary cost with little or no benefit and potential risk. This is why it is not necessary to include specialists on these panels because of their “expertise”. Other scientists can interpret the data accurately; a panel reviewing the data on, say, the frequency with which mammography should be performed in a particular population does not need mammography radiologists and breast surgeons to understand the research. This is not to say that such specialists are inherently biased and shouldn’t be on USPSTF; they could be as objectively good scientists as others. But it is to say that the reason being put forward for them being added to the panel – that they are ‘experts’ in the topic – is wrong. They should not bring their experiences and expertise to ‘balance’ the data. They should be guided by it.

It is not necessarily true that expert specialists are purposely obtuse, that they will advocate for recommendations that will make them more money. It is also true that their perspective is skewed by the populations that they see. Specialists see people with a disease, which is a selected population. Screening is, by definition, testing people who are asymptomatic and are statistically unlikely to have the disease. Therefore different standards are applied for screening asymptomatic people (say, all adult women between 50-75 by mammography) and for following up people previously diagnosed with breasts cancer, or those who are at higher risk (defined as a first-degree relative, mother or sister, with breast cancer, not a great-aunt). And, of course, doctors are not necessarily above advocating for laws to keep their incomes up. When, about 20 years ago, the federal Agency for Health Research and Quality (AHRQ) recommended against a specific type of spine surgery because it didn’t help, was risky, and cost a lot, groups of spine surgeons tried to get that agency defunded! Oh, yes, and AHRQ continues to be threatened with funding cuts because special interest groups don’t like their findings!  With the ACA requiring insurers pay for any USPSTF recommendation with an “A” or “B” rating, the political pressure is on to get such recommendations, whether the data supports them or not. On the positive side, the American Academy of Family Physicians (AAFP) has come out against such stacking of the USPSTF.

Once, when I lived in a good-sized condominium, I was one of the few families with children, and it seemed like they and their friends were often harassed for violation of (sometimes) condo rules and (more often) an individual’s belief of what should be a rule. Even the rules, however, were often, in my opinion, unreasonable; I thought the condo association rules should protect our investment and our safety, but should not be just anything 51% of the owners wanted. On the positive side, while they may have inconvenienced me and my family, they did not try to overrule natural law or science. The same cannot be said for current federal, state, and local efforts to make a law about anything they want to be true. They cannot make global warming disappear by a law, but they can make it illegal! And they can violate the rights and human dignity of our people. And stack federal agencies with anti-science people or at least turn what should be scientifically-driven decisions into a political negotiation.

This is going to be a long battle. Those with money and power are entitled and feel that it is their right to stack the deck. Happy New Year!

Opioids and other pharmaceuticals are the tip of the iceberg: It's the profit, stupid!

The NPR program “Fresh Air”, with Terry Gross, had Anna Lembke, MD as a guest on December 15, 2016. Dr. Lembke is the author of the recent book “Drug Dealer, MD”, in which she apparently (per the discussion on air; I have not read it) implicates physicians and pharmaceutical companies in the widely discussed “opioid epidemic”. Dr. Lembke is a Stanford psychiatrist and director of the addiction medicine fellowship there, and she is able to articulately describe what is known and what is not about the neurological impact of opiates and opioids on the brain. One important point she makes is that continued use of opioids causes tolerance and a need for higher doses; in addition she describes how chronic use of opioids causes a pain syndrome of its own (decreased tolerance to pain) in some people, and how weaning them off opioids can actually decrease or eliminate their pain.

Her key issue, however, is that the epidemic of opioid use was orchestrated by the pharmaceutical manufacturers of opioid analgesics, who heavily promoted them, created the perception among doctors and the public that physicians were heartlessly undertreating the pain that their patients were in, and hooked in (mostly) well-meaning doctors to become, in essence, their pushers (“Drug Dealer, MD”) while they made huge profits. And continue to do so. And, as the reaction to this epidemic begins to form, continues to promote new syndromes that require treatment with their drugs.

An example of this is “OIC”, opioid-induced constipation, which made its first big appearance during the Super Bowl of 2016. The commercial left it a vaguely mysterious ailment, but it is a real one. Of course, the commercial was a prelude to an advertising campaign, in this case for Movantik ®, a partial opioid antagonist manufactured by a collaboration between AstraZeneca and Daiichi Sankyo designed to treat this condition. Constipation, in fact, is the only side effect of opioids that does not decrease with continued use, so as a person uses higher and higher doses of the opioids to try to control their pain, their constipation gets worse and worse, sometimes requiring surgery and occasionally death from a ruptured colon. My reaction, while understanding we would soon see a drug for this condition promoted, was that it was a cynical and disturbing attempt to “normalize” opioid addiction. “Oh, you have this problem? Well, it’s not just you! LOTS of people have OIC!” It turns out that I was not the only one with this reaction; Ahiza Garcia on in a piece on CNN Money called “Super Bowl drug ad sparks big backlash”, quotes Dr. Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing: "It's very disturbing to see an ad like that. It's normalizing the chronic use of opioids, which aren't demonstrated to be safe over the long term.”

Of course the greed and anti-social behavior of pharmaceutical manufacturers is neither new nor is it going away. Their efforts to use doctors and exploit the public as much as they can possibly get away with in pursuit of exorbitant profits continues to generate news, and occasionally, reaction by states. We have all heard about the huge price increase in Daraprim ® by Martin Shkreli and Turing (Drug prices and corporate greed: there may be limits to our gullibility, September 27, 2015) and Epi-Pen® by Heather Bresch and Mylan (Epi-Pen® and Predatory Pricing: You thought our health system was designed for people’s health?, September 3, 2016) and maybe thought that this publicity would rein in further abuses. But not so. Reuters just reported in “US states sue Mylan, Teva, others for fixing drug prices” that “Twenty states filed a lawsuit Thursday against Mylan NV (MYL.O), Teva Pharmaceuticals (TEVA.TA) and four other generic drug makers, saying they conspired…on pricing of two common generic drugs, according to a copy of the complaint.” Lest you think that this conspiracy is just preventing these companies from being undercut by each other, we are talking fantastic price increases for common and necessary drugs. “The drugs involved in Thursday's lawsuit include the delayed-release version of a common antibiotic, doxycycline hyclate; and glyburide, an older drug used to treat diabetes. Doxycycline, for example, rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014, according to Senator Amy Klobuchar, a Minnesota Democrat who had been pressing for action on high drug prices.” In case you missed it, this is a 9245% increase in the price of doxycycline! And it may well be up to the states to bring such legal action, since there is little reason to think that the federal government, led by President-elect Trump and his corporate cabinet, along with the Republican-dominated Congress, will be doing anything about it.

Which, of course, is the core problem, and has been for a long time. Corporate profit has become the be all and end all of US policy. Anything that increases corporate profit is seen as good. This certainly includes subterfuge, cheating, exploitation, and corruption. While this has long been the case, it is likely to increase under the Trump administration, with its depressing panoply of corporate exploiters and climate change deniers. We are likely to see not only tolerance of encouragement and celebration of such outrageous excesses. Of course, it is fine to make a profit, but that profit should be reasonable and honest; it should not be highway robbery, generated by dishonesty, exploitation, and trampling others.

The pharmaceutical company activities cited about are the result of an attitude that “if we can make some money honestly, look how much more we can make if we are corrupt!” that pervades virtually every industry, from fossil fuels (see Rex Tillerson, the Exxon CEO who is Trump’s nominee for Secretary of State) to financial services. After campaigning against Goldman Sachs, the largest investment bank, and its ties to Hillary Clinton (“I know the guys at Goldman Sachs. They have total, total control over [Cruz]," Trump said. "Just like they have total control over Hillary Clinton"), Trump has named at least four current and past Goldman execs to cabinet-level positions, including its #2, Gary Cohn, as director of the National Economic Council. And, should anyone harbor any illusion that the survival of Goldman in the face of the collapse of rivals Bear Stearns, Merrill Lynch, and Lehman Brothers has anything to do with their being more honest or less evil, less likely to have indulged in “the Big Short” and transferred all their toxic investments to their own clients, read the recent piece by Matt Taibbi in Rolling Stone, “The Vampire Squid occupies Trump’s White House”.

Speaking of Rex Tillerson, his close ties to Russia and Vladimir Putin are seen (by the President-elect) as major qualifications for Secretary of State. In this context, the New York Times Op-Ed by Andrew Rosenthal from December 15, 2016, “To understand Trump, learn Russian”. Rosenthal notes that Russian has two words for “truth”:

The word for truth in Russian that most Americans know is “pravda” — the truth that seems evident on the surface. It’s subjective and infinitely malleable....But the real truth, the underlying, cosmic, unshakable truth of things is called “istina” in Russian. You can fiddle with the pravda all you want, but you can’t change the istina.

The pravda will change a lot with the new administration. Fossil fuel extraction is all good, climate change is a hoax, public education is bad, getting rid of the ACA will improve access to healthcare, immigrants are the problem, Putin is good, and gays and transgender people have no rights. That putting foxes in charge of the henhouse makes sense, and that having corporate titans in direct rather than indirect control of government will benefit us all. But the growth in the gap between the wealthiest and the rest of the people has grown under both Republican and Democratic administrations and anger at it was actually one of the drivers of the vote for Trump.

The istina, though, is that making the wealthiest wealthier and destroying the earth in the process is not the answer. Attention to the common good, for all of us, is the only thing that will move us forward, as a society and as a world.

The urban-rural divide and the health of people in both settings

I recently wrote about the impact of the massive vote for Donald Trump by “white working class” voters and how it will have repercussions for their health, as well as that of others, if the policies advocated by the Republican majority (as exemplified by Secretary of HHS nominee Rep. Tom Price) are implemented. And there is little doubt that they will be implemented, but slowly, so people are less aware of what is being done to them. As Medicare is increasingly privatized, as vouchers that cannot cover the cost of health insurance for those with chronic disease are implemented, “Medicare for all” will increasingly seem a poor idea. And people’s health will suffer. I wrote about the cynicism of the AMA and the AAMC in endorsing Mr. Price; they are doing more than “kissing the ring”, as a colleague suggested. They are lauding the fact that one of “theirs”, a doctor, will be in this role, not an insurance executive. But if anyone had a doubt about whether having an “MD” at the end of your name guarantees a concern for people’s health, Mr. Price is the poster child for “not so”.

The other big divide demonstrated by the election is urban-rural, and this one is also real. A majority of the people in the US are jammed into small geographic areas, urban islands. Maps that portray “red states” and “blue states” seem to be an ocean of red because of physical size; think New Jersey  (population about 9 million, with 8700 square miles, more than 1000 people/sq mi) vs. Montana (just over 1 million, in 147,000 square miles, less than 7 people/sq mi). The contrast is even greater if we look at counties; most of the population of even “blue” states is concentrated in a few urban counties, although, conversely, there are many “blue” seas and islands in “red” states, cities like Houston, Dallas, San Antonio, St. Louis, Kansas City, etc. The media has recently been awash in articles about the way that our Electoral College system advantages rural areas; because of the 2-Senate-seat-per-state rule, a Wyoming voter has 5 times the clout of a Californian. See, for example, Steven Johnson’s “Why blue states are the real Tea Party” in the NY Times, December 4, 2016. He points out that at the time of the writing of the Constitution, the urban northern states were in debt while the southern states were solvent – largely through the magic of the free labor of slavery. Now cities are the engines of our economy; they are where ambitious and educated young people go, leaving rural areas increasing older and poorer (as well as whiter).

But we need to remember that there is tremendous need in rural America, as there is in the inner city. Rural areas are poor, and underserved both medically and in terms of social services (as well as, of course, in the other things you’d expect – access to groceries, for example). Those rural areas that are located in “red” states are even worse off, because those states spend far less on health care and social services in the first place so that their more isolated communities are in the worst shape. And yet, as Johnson points out, they get far more federal aid for tax dollar contributed: New Jersey receives $0.61 on the dollar while Wyoming gets $1.11. The Trump campaign, and the Republican Party, strongly appealed to voters in these areas, but Trump and his proposed cabinet all live and work in cities; they are not rural billionaires. Tom Price is a suburban doctor; he does not deliver care to the rural poor, as do Rural Health Clinics.

So there is tremendous need in rural communities, but their political clout, which is both unfair and anti-democratic, is not being used to actually help the people there, but rather to limit positive policies in urban areas. The North Carolina “bathroom law”, to force people to use the restrooms of the gender of their birth, was a reaction to the city of Charlotte (a blue “lake”) making it legal for people to use the restroom of their current gender. The most well-publicized efforts currently are threats by Trump and his people to forbid cities from declaring themselves “sanctuaries” for immigrants (see NY Times debate on whether sanctuary cities have a right to defy Trump, December 1, 2016; “yes” by Cesar Vargas and “no” by Jan C. Ting). These cities are trying to exert their local control over such important issues, while states (generally supported by rural populations that do not actually have to deal with these problems) try to restrict their ability to do so. These hypocrites are against government regulation when it comes to their rights to carry guns or graze their cattle on public land (things they want to do), but are all for it when it comes to things important to others, like deciding who can marry, where one can go to the bathroom, whether people can get an abortion or even contraception. “Those who deny freedom to others,” said Abraham Lincoln, “deserve it not for themselves”, which I first learned as a young stamp collector; it appears at the 4 cent American Credo stamp.

If the selective interpretation of what “freedom” means is not enough, if rampant discrimination and bigotry is not enough, there are other, health related, concerns that go with this divide. For example, federal funds for HIV care go to the area where patients are from. However, a large percentage of gay HIV patients leave those areas for the cities where they are more accepted. Thus the cost of providing that care is borne by the cities, while the money flows to the rural areas where services are not available – and often the victims themselves are not welcome.

A recent article published in Science Direct by Jason Beckfield and Clare Bambra, “Shorter lives in stingier states: Social policy shortcomings help explain the US mortality disadvantage” demonstrates that the lack of social services in the US leads to shorter lives than in other Organization for Economic Cooperation and Development (OECD) countries, i.e., the rich countries. The “highlights” of their study are that:

• The US combines a laggard welfare state with shorter life expectancy compared to the OECD.
• Fixed-effects models show associations between life expectancy and social policy generosity.
• US life expectancy would be 3.77 years longer if the US welfare state were just average

In this article “state” refers to nation-states, comparing the US to other OECD countries, but similar differences can be seen among the US states, again depending upon their social services, including public health and access to health care. This is supported by a new study from the Commonwealth Fund which finds that “adults in the U.S. are more likely than those in the 10 other countries to go without needed health care because of costs”. A third of U.S. adults “went without recommended care, did not see a doctor when sick, or failed to fill a prescription because of costs”, as compared to as few as 7-8% in other countries. They were also the “most likely to report material hardship. Fifteen percent said they worried about having enough money for nutritious food and 16 percent struggled to afford their rent or mortgage.”

This is not good for our country, not good for our health, and not good for our lives. And as far as we can see, the new administration’s plans are not to fix it but to make it worse.

Trump, Price, and Verma: Bad news for the health of Americans, including Trump voters

The election of Donald Trump as President continues to be extensively analyzed. It demonstrates major divisions among our populace. One of those that has been discussed a lot is that the “white working class” that voted for him by a 2:1 margin will suffer a lot from the policies likely to be implemented by his administration. Not more, and probably less, than minority people, but a lot.

Healthcare and health insurance is one of those areas, as discussed by me in several recent posts and by Paul Krugman in the New York Times, December 2, 2016, “Seduced and betrayed by Donald Trump”. He notes that anger about their health care coverage, and in particular the dramatic increases in premiums under the ACA exchanges, drove many people to choose Mr. Trump’s promise to replace it with “something terrific”. Of course, he never specified what that would be, for the same reason that the Republicans in Congress have never been specific, which is that any replacement plan that does not move “left” toward a more universal coverage plan such as the single-payer advocated by Senator Bernie Sanders (and me) will be much worse for most people, including most Trump voters, who will either lose or have to pay a lot more (if they can!) for their health insurance coverage. Repealing Obamacare means that many of the 13 million newly insured (a majority white, for the record) who received insurance under the exchange will not get rate cuts, but rather they will get no coverage. Certainly not those who need the insurance most, because they have pre-existing conditions that insurance companies were mandated by ACA to cover. As Krugman puts it, “we’re probably looking at more than five million Trump supporters, many of whom have chronic health problems and recently got health insurance for the first time, who just voted to make their lives nastier, more brutish, and shorter.” This is made clear in the Times article on December 3, 2016 “GOP plans immediate repeal of health law, then a delay” by Robert Pear, Jennifer Steinhauer and Thomas Kaplan. The reason is because the only plan they have will yank health insurance coverage for so many people, and despite their vociferous opposition and multiple votes to repeal ACA, they do not want to do that, at least right away.

The best evidence for their long term plan to, basically, remove health insurance coverage from many Americans including their base of support is the appointment of Rep. Tom Price (R, GA) as HHS Secretary. Mr. Price has been a leader of the Tea Party movement and a major Congressional figure calling for the repeal of Obamacare. His solution is not completely fleshed out, but does include eliminating guaranteed issue, community rating, and federal support for the exchanges. He is a fan of vouchers, an idea advocated for decades by conservative think tanks, and which, I guarantee (and this is far more of a certainty than Mr. Trump’s promises), can NEVER work, especially over the long term. Vouchers will never cover the cost of a decent insurance policy; people with health problems will naturally be the first to seek coverage, and faced by the adverse selection insurers will raise the premiums, co-pays, and deductibles for them. If there are problems with this under Obamacare, vouchers will make those look pale by comparison. And by getting out of the running-the-infrastructure business, the government will ensure that it never gets better.

Price, a wealthy orthopedist from suburban Atlanta, does not really care. He represents rich doctors who want to be able to charge whatever they want to be able to charge, and care only for the people who have insurance good enough to pay it. Sorry, Trump voters with not much money, chronic disease, and difficulty paying even ACA premiums, that isn’t you. And when you get to an age that you can get Medicare, finally having federally-supported coverage, Mr. Price has another answer for you – privatize Medicare! Make it subject to the same market forces that have made health care and health insurance so unaffordable and unavailable to younger folks affect the elderly too! The ACA has modified the egregiously negative impact of private sector health insurance for the under-65 group; the crumbum Price wants to both reverse that benefit and extend the damage to seniors too.

When Lyndon Johnson signed the Medicare law at the Truman Library in 1965, presenting Harry and Bess Truman with cards #1 and #2, he quoted the former President from nearly 20 years earlier: "Millions of our citizens do not now have a full measure of opportunity to achieve and to enjoy good health. Millions do not now have protection or security against the economic effects of sickness. And the time has now arrived for action to help them attain that opportunity and to help them get that protection." LBJ then added that “There are more than 18 million Americans [in 1965; way more now] over the age of 65. Most of them have low incomes. Most of them are threatened by illness and medical expenses that they cannot afford. And through this new law, Mr. President [referring to Mr. Truman], every citizen will be able, in his productive years when he is earning, to insure himself against the ravages of illness in his old age.”

This is what Tom Price and his colleagues want to reverse. The AMA, with its shameful history of actually having blocked Truman’s health plan, and unsuccessful opposition to Medicare, is endorsing him. The Association of American Medical Colleges (AAMC) is endorsing him as well. The American Academy of Family Physicians (AAFP) more tepidly expresses optimism. Presumably these are political decisions, to maintain access. After all, in the ongoing battles between insurers and providers (patients are rarely a real player), at least he is a provider. But many others, including Physicians for a National Health Program (PNHP) and Common Dreams, as well as the medical students of Future Docs, have appropriately condemned Price and these organizations endorsing him.

Mr. Price will be joined by Seema Verma, who will head the Center for Medicare and Medicaid Services (CMS). Verma helped Mike Pence design the Indiana version of Medicaid expansion. On the plus side, that state did expand Medicaid, helping people more than those states that did not. On the minus side, the requirement that everyone covered has to pay meant at least 1/3 of those who would have been eligible did not sign up. I guess she is the moderate!

Mr. Trump’s cabinet picks are, so far, a panoply of people who are either right-wing ideologues who wish to destroy everything that has been done to help the American people at least back to the Great Society and maybe to the New Deal, or are billionaires who speak for the corporate financial ruling class that he attacked so effectively during his campaign, or both. An example of the latter is anti-public education billionaire Betsy DeVos to head the Department of Education. Myron Ebell, a noted climate-change denier, will head EPA. Steven Mnuchin, a leading Goldman Sachs banker, will be Treasury Secretary. Senator Jeff Sessions (R, AL), denied a judgeship because of his racist beliefs and practices will be Attorney General. Trump's nominee for Commerce Secretary, Wilbur Ross, according to Money, alone has 10 times the net worth of the entire cabinet of President George W. Bush. Talk about foxes guarding the henhouse! Compared to these folks, naming El Chapo to head the DEA, as suggested in a New Yorker satire by Andy Borowitz, would be a moderate pick.

The future of not only public health, but also your individual private health, now and when you get to retirement age, is in great jeopardy. But, then, so is everything else that helps people. Not to mention the earth, since global warming is likely to accelerate during a Trump administration. There is an endless string of battles before us.

And we must join every one.