Freedom -- methinks that word does not mean what you think it means

Some deep thinkers including Ezekiel Emanuel (who has been guilty of some shallow thinking lately, but that's beside the point) argue in JAMA a point I have often made here. (I think you common rabble are likely to get bounced to the first 150 words.)

To put it succinctly, the outraged claims by self-styled conservatives that requiring people to buy health insurance is an infringement of individual liberty are nonsensical. They are, as Click and Clack put it, unencumbered by the thought process.

If you are strongly committed to individual liberty and personal responsibility, then you ought to be a passionate supporter of the individual mandate. And here's the thought process, which is not very complicated.

Basic human ethics incorporates what is called the Rule of Rescue. This is universal -- it applies in every culture. We have an obligation to provide urgent assistance to people in dire straits. If you walk by a pond and see a child drowning, you must rescue the child. Physicians have an additional layer of professional responsibility.  When people show up in the Emergency Department with massive trauma, or anaphylactic shock, or status asthmaticus, or in labor, the personnel are required to treat them. It isn't even possible to determine if the person has insurance before acting. No matter how young and healthy you are, it is entirely possible that at some time you will require urgent care, and that the cost of that care will exceed your assets. You will therefore have imposed a burden on others -- forced them to pay, involuntarily, to meet your needs. There is nothing libertarian about that.

Zeke and friends stop there. They don't argue that people are morally obliged to buy insurance beyond a policy that will pay for situations that invoke the Rule of Rescue. That would require a step or two further in the thought process. I will just point you down that road -- you can think for yourself.

There are many costs to others when people do not receive basic health care. These include the possibility of transmitting infectious diseases; inability to care for dependents, thereby making them a burden on the state; inability to perform productive labor thereby harming the economy and shifting tax burdens to others; causing emotional distress to others who observe sick and suffering people around them. Perhaps you can think of others.

Everyone benefits when everyone has access to basic health care, and to critical care and curative care. If you can afford health insurance, but you prefer to take a chance that you won't need it, you are taking a chance that you will place burdens on others and harm all of society. That diminishes my liberty. QED.

I'll largely out-source today's post . . .

.  . . To Jackie Calmes of the NYT, who notes (as I have here previously) that the Republicans are simultaneously running against Barack Obama for "cutting Medicare," and for not cutting Medicare enough. They can get away with this, obviously, because with the apparent exception of Ms. Calmes, "reporters" nowadays can't be bother to understand the issues they report on; to point out contradictions, lies or nonsense; or even to comprehend fundamental distinctions. The politician or flack says something, and they write it down or repeat it for us. That's the basic job of a journalist in the 21st Century.

The fundamental distinction here, that the Republicans are pretending away, to which the stenographers of the press corps are oblivious, is between:

a) Spending money on Medicare (or any other health care insurance); and

b) Providing health care benefits to people.

Democrats want to do more of (b), while limiting (a). This may appear to be a contradiction of some sort, but it is not. On the contrary, you can't do (b) without doing (a) because the supply of resources in the universe is finite; and anyway a lot of money is wasted or spent on actually harmful interventions. If you want to get better health care to more people, you need to make it more efficient.

Republicans, on the contrary, want to do more of (a), and less of (b). Well, okay, their proposal would constrain Medicare spending overall, but would not constrain health care costs, so the profit to providers would be protected; and they would keep getting more and  more money from people who can find some way to scrape up the dough to pay them. People who can't scrape up the dough will be shit out of luck. That's because the Republicans'  constituents are the people who get paid the money, not the people who receive the health care. There's no contradiction there either, but there is a contradiction between the two positions.

And it is precisely that contradiction that the public does not understand, and nobody seems to be explaining to them.

Methodology 101, next installment: Case Control Studies

This new study is a twofer, because it illustrates the study design I wanted to write about next, and the finding is also right up our alley. Some folks in jolly old England were interested in whether pharmaceutical companies might be exercising subtle influence over medical journals by ordering thousands of reprints of studies they sponsor.

I realize this is a bit arcane to begin with. Traditional journals depend on two or three sources of revenue: subscriptions, reprints, and advertising. Subscriptions to medical journals nowadays can cost hundreds of dollars a year, which basically means that only libraries subscribe, with the exception of members of medical societies that publish journals. Only very widely read and influential journals attract significant advertising, and most of that, obviously, is from drug manufacturers. That sounds possibly bad, but in most cases it isn't obviously corrupting because it would look really bad for the companies to pull their ads if they didn't like the journal's content. (There have, however, been a couple of scandals.)

Reprints are another matter. Because these journals are very expensive, and it would be a violation of copyright to photocopy and distribute articles, if you want to get a paper into the hands of lots of people, you need to pay for reprints. Drug companies, obviously, have an interest in disseminating articles that support the use of their products, so they may purchase as many as 125,000 reprints. They aren't likely to purchase reprints of studies that aren't so favorable, obviously.

So, what is a case control study? Basically, the researchers identified papers in high impact journals for which there had been large numbers of reprint orders -- the top 20 or top 10 in a given year. In this study design, these are called the cases. Usually, "cases" are people who have a particular diagnosis. These cases are then matched with people who don't have the diagnosis, or in this instance articles for which there were not high reprint orders. You try to find controls that are as similar as possible in other characteristics that might affect the outcome. If we're talking people, you look for controls of about the same age, same body mass index if that is relevant, whatever it may be. In this instance they found the study of the same type (e.g., randomized controlled trial, editorial, etc.) that immediately preceded the case article in the same journal.

The next step is to see if there is a difference between the cases and controls in some hypothesized causal factor. This time, it's industry funding of the study. Sure enough, high reprint articles were much more likely to have been funded by the pharmaceutical industry.

A couple of points. The statistical method used in case control studies is called logistic regression, and the output is an odds ratio, not a rate ratio. Technically, you cannot calculate the rate ratio from the odds ratio unless you know the underlying rate in the total population. Let's say 2/3 of cases have the hypothesized association and 1/3 of controls have it. The rate ratio in this case is obviously 2 - twice as many cases have the thing as controls. But the odds for the cases are actually 2:1, or 2; and for controls, 1:2, or 1/2. That means the odds ratio is not 2, but 4. (Sorry to have confused you, it isn't really important.)

Second, this doesn't prove causation. There could be something else that goes along with industry funding that actually explains the result. However, editors of traditional journals obviously have a strong financial incentive to publish studies with industry sponsorship.

Open access publishing eliminates this potential source of bias. One more reason why we're all for it.

For those who are interested . . .

 This editorial in JAMA helps clarify the concept of the Patient Centered Medical Home and its relationship to Accountable Care Organizations. I don't have much to add to it except to tease out one important problem.

It has been shown that the PCMH model can indeed reduce overall health care costs by avoiding unnecessary hospitalizations and ER visits. The problem is, the PCMH -- which is essentially a primary care practice -- doesn't capture any of those savings. But, it costs slightly more per patient to be a PCMH.

Remember that the PCMH is a model of health services delivery based in primary care practice; whereas the ACO is a model for paying for medical care. The financial relationship between the PCMH, and hospital and specialty services is generally unspecified. The ideal is that they be included within the same ACO and that the ACO allocate sufficient funds to the PCMH to support it in successfully reducing hospitalizations, ER visits and other specialty services resulting from avoidable complications. Based on the evidence we have now, that will simultaneously result in lower overall costs, healthier patients, and happier doctors.

What's not to like? The problem is that these are all wonky arguments that most people don't understand. It's very easy for politicians to distort the issues and scream about bureaucrats and government takeovers and similar scare words. After 20 years of screaming and yelling about these issues, I despair of ever cutting through the fog and getting average folks to understand.

Sigh.

Deep and not so deep doo doo

As I noted a couple of days ago, the Penn State executives who decided not to report Jerry Sandusky to the authorities are in it deep enough they're breathing with a snorkel. They're unemployed and unemployable, two of them are facing criminal charges, and former PSU president Graham Spanier may also be prosecuted. All three of them are looking forward to being sued for their back teeth. (No surprise they aren't cooperating with the Louis Freeh investigation. Spanier is even suing to try to obstruct it. Don't expect a whitewash from Freeh, but do expect something close to it -- a pale beige at best. PSU is paying for his investigation and they aren't paying him to write a roadmap for litigants. But I digress.)

Contrast this with even wealthier and yet more evil executives at GlaxoSmithKline. They didn't just look the other way while somebody raped a couple of dozen boys. They conspired actively, elaborately, over years, to illegally foist drugs on tens of thousands of children that caused them untold harm; and they ripped off millions of adults as well by selling a drug -- which has serious side effects -- for purposes for which it is useless.

Well, the company is paying a $3 billion fine, which yeah, most people would consider a lot of money. But I expect it's less than the profit they made from the scheme -- it's just a cost of doing business. But guess what? The people who did this committed crimes more egregious than the crimes of Jerry Sandusky, by orders of magnitude, if you go by the number of people they harmed. Some likely died. Yet nobody will be prosecuted. They haven't lost their jobs either. I expect they all got bonuses.

Would love to hear the explanation. Oh I think I already know it.

Maybe a tipping point?

With respect to climate change, "tipping points" are when positive feedback mechanisms start to run out of control and amplify effects, regardless of whether human emissions of greenhouse gases continue to increase. For example, as the arctic permafrost thaws it release C02 and methane; as the sea ice melts the open water absorbs heat from the sun instead of reflecting it back as ice does; as glaciers start to thaw the meltwater runs down underneath and lubricates their slide to the sea.

All of that is happening. But there does seem to be a bit of good news: The corporate media is finally starting to catch on that this is not a legitimate controversy. Until approximately now, every story that mentioned anthropogenic climate change (and they were few and far between) had to feature a he said/she said exchange between legitimate climate scientists and corporate-funded frauds; and an explicit denial that any particular weather event could be linked to climate change.

Those impregnable requirements finally seem to be disintegrating like the West Antarctic ice sheet. Even the New York times is, at long last, giving up its policy of being Fair and Balanced about this phony controversy.

Is it too much to hope that the Koch brothers billions can no longer bury the truth? Just as the effort by the North Carolina legislature to declare the sea not rising was immediately rebuked by reality, their lies are going up in flames with the Colorado forest. The legislature can't repeal the law of gravity and the Koch brothers can't buy an alternate reality. How long it might be before this matters for public policy I cannot say. But it's a start.

Sorting through the rubble . . .

. . . left by Jerry Sandusky. CNN has the latest info about deliberations among Penn State execs considering whether to report Sandusky to the authorities. This does not look good for them or for Penn State University, but I'll get to that.

There probably isn't a whole lot left to say about this case -- although I promise you a lot more will be said as more information comes out and we go down the road of years of criminal and civil litigation. But I haven't seen anyone comment on the sheer immensity of the destruction that one man could wreak. This is important, in fact, to our interpretation of history.

Obviously we have to begin with his most direct victims, the boys who he exploited for his gratification. We will never know how many there were, but the police have intimated that they are aware of somewhere north of 20. I'm sure it's many more than that.

But consider: he established a charitable organization, and helped it raise millions of dollars, for the purpose of providing himself with a continual supply of vulnerable children, fully documented with all of the information he needed to make his selections and work his methods. He even kept annotated lists of boys, provided by the organization, in his desk at home, evidently to guide his choices. Sandusky used and betrayed all of the donors and volunteers associated with the Second Mile as callously as he used the boys. The staff of the Second Mile now find themselves out of work and I can't imagine their job searches are going well. How are you going to apply for a job as an executive or director of development for a charitable organization when the last thing on your resume is the Second Mile? Good luck with that. And no, as far as any publicly available information is concerned, they had no idea.

Now consider Penn State football. Not that I particularly care about it, but thousands of young men went through the program and it meant a lot to them. They were proud of it. Linebacker Lavar Arrington has already come forward to express how betrayed he feels, and I'm sure he's just speaking for the entirety. Presumably Sandusky wasn't figuring on getting caught but he had to know it was possible.

So now we come to University. Many people have gotten up on their high horse and proclaimed that PSU needs to cough up the tens or hundreds of millions it's going to take to settle with the victims without any quibbling in order to restore the honor of the university. But PSU did not perpetrate these crimes, nor did PSU cover them up. Specific people did that -- namely Graham Spanier, Tim Curley, and Gary Schultz, and apparently Joe Paterno, based on CNN's second-hand reporting about e-mails they haven't actually seen. Okay, Paterno is dead and the other three are out of work, with at least two of them and probably all three facing prosecution. There are important lessons about the judgments they made and what it all means, which I will not belabor.

However, Penn State is not the football team, and it is not these four men. It is a major university with a mission of research and teaching. Those hundreds of millions of dollars aren't going to come out of the football program, they're going to come out of student aid, instruction, and scholarship. Where else?

I can believe that free will is an illusion and still call this man indescribably, immeasurably evil. Unfortunately that does not make him unique. But he happened to be a football coach at Penn State, instead of Ohio State; or perhaps a professor at Harvard, or an executive of the Boys and Girls Club of America, or a United States senator or the Prime Minister of England. You name it. The actions of individuals can have enormous repercussions beyond their immediate reach. Obviously that goes for the single moral choice made by Graham Spanier as well as the decades-long campaign of horror waged by Jerry Sandusky. Our lives, and everything we value, are always balancing on a knife edge. Try to do the right thing. 

Prediction is hard . . .

. . .especially when it comes to the future. Marcia Angell takes a shot at it anyway  . (I try not to link to the Puffington Host, but that's where this is so what can I do? Do not rely on the site as a source for health advice or scientific information!)

Dr. Angell wishes the Supreme Court had thrown out the Affordable Care Act because a) she thinks it's going to be a train wreck and b) if they'd thrown it out, we all would have been "energized" and gotten the universal, comprehensive, single payer health care we actually need.

As I have been saying, yes, it won't work without additional reforms and what will be a very tough political struggle to move the development of the system along the right path. But why that's supposed to be more difficult than blowing the whole thing up and magically passing a single payer plan is mysterious indeed. Angell worries, as do I, that costs will simply continue to soar and that even with subsidies too many people will decide they can't afford insurance and will just pay the penalty. The problems of adverse selection will just get worse and meanwhile, the rates paid by Medicare and especially Medicaid will be so low that lots of people just won't be able to find doctors, while people who do have private insurance will have crappy plans with unaffordable co-pays and deductibles so they won't even be able to use them.

Okay, that could well happen if everybody just hits the champagne and then goes home, like I said the other day. But let's you and I and Dr. Angell all agree not to do that. We have now an opportunity for Barack Obama and non-wingnut politicians and even the occasional, rare journalist to explain to people how the market for health insurance works and why it fails; what the act actually does and how it isn't going to force your doctor to fill out a form in triplicate and get permission from a mid-level civil servant in Bethesda before writing you a prescription, nor will it put Granny on an ice floe; and what we still need to do to make the thing work properly.

Insurance companies won't like those reforms but guess what: other employers will. So will most of the physicians' organizations, that really do want the system work for their patients even if interventional radiologists won't make a million dollars a year. So will lots of people who are actually knowledgeable. The Koch brothers, by the way, don't actually give a shit one way or the other, they just want to use this as a blunt weapon with which to cudgel Barack Obama and Democrats, as a means to their entirely unrelated ends. The only people who are truly against the Affordable Care Act and the payment and delivery system reforms we still need are health insurance companies, and to some extent perhaps drug companies and medical device makers, and ignorant far right ideologues who would have been for it if a Republican president had signed it.

I still think we have a chance. But waving a magic wand and passing single payer? Not going to happen.

Let me elaborate

I made a couple of broad assertions in the previous post, I realize most readers won't know exactly what I was talking about.

In the first place, the law regulates insurance markets so that insurers must offer a basic package of benefits, and cannot engage in medical underwriting -- that is, they must sell a given policy to anyone who wants to buy it, and they have to charge the same price regardless of the person's state of health or health history. There is an exception in that they can adjust prices for age, but obviously that only goes up to age 65 at which point everybody gets Medicare so it's not a horrible problem. They are also required to pay out a minimum percentage of the premium in benefits.

That means the only way for them to maximize their profits is to get more customers, and if they want to compete on price, they have to find ways of delivering those minimum benefits for less money. That means they have to work with providers to find efficiencies, which allies their interests with some lesser-known provisions of the ACA. These create incentives and investment to experiment with new ways of organizing and financing health care delivery. The basic idea is that providers get paid for results, not for doing more stuff.

There are a lot of complexities involved, but the current buzzwords are Accountable Care Organization (ACO) and Patient Centered Medical Home (PCMH). These are somewhat overlapping concepts but the first puts more emphasis on how providers are reimbursed, and the second on how they are organized. An ACO, however organized, gets paid mostly on a capitated basis -- i.e. they are responsible for you as a patient, and they get paid an annual fee to take care of you, no matter what they do. But they are accountable in that they get paid more or less depending on various quality measures. Note that they are only accountable for the services within their organization, in other words if you get hit by a bus your trauma surgery may be paid for separately, if that's not part of the original deal.

A PCMH is probably compensated as an ACO, and an ACO probably tries to be something like a PCMH, but they aren't exactly synonymous. A PCMH means that one organization provides all, or at least most, of the services you are likely to need, i.e. your primary care doc is there and works under the same umbrella with specialists and ancillary services like physical therapy and social workers. They have a lot of extra services such as easy accessibility of a nurse if you need to talk about stuff, health educators, people to come to your home if you have complicated comorbidity or are losing your marbles who will work with you and any significant others to set up a plan for self-management, transportation vouchers if you need them to get to appointments, etc. All of this is paid for, presumably, by the money saved by keeping you out of the hospital or avoiding complications of diabetes or whatever.

Finally, there are research dollars invested through the Patient Centered Outcomes Research Institute (PCORI) to figure out what treatments work best for which patients, what the tradeoffs are of alternatives, and how to explain it to you so you can make informed choices on your own behalf; and the Center for Medicare and Medicaid Innovation which supports experiments in the organization and financing of health care as described above and tries to figure out how to deliver better results for less money.

In order to make all this work we need additional infrastructure such as electronic medical records, and decision support and informational tools for docs and patients. It's in there.

Now, actually getting individual health care providers, and institutions such as group practices, hospitals, and integrated medical systems, to take this stuff up and make it work is a long road to travel. We need to learn more about how to do it and we'll need to write new rules and regulations. Yes, there is an essential role for government in the health care industry to make this work, and it will gore many a fat ox. The political obstacle course will be as challenging as ever. But at least we've stepped onto it and jumped the first hurdle.

I'll try to say more about all this as we go along, and will be happy to answer any questions.

Celebrate briefly . . .

Good. Now sober up. If we are to make progress toward solving the critical failings in our health care non-system, we need to deal with the problem of universal access, and we need to tame the perverse market forces that suck up money while hurting patients.

The Affordable Care Act doesn't actually accomplish either of those goals -- especially with states free to refuse to participate in the Medicaid expansion, which I suspect Texas and Mississippi will do, at least for as long as they can hold out. But the Act does create a regulatory framework which makes it possible to make progress toward those goals.

If the court had overturned it -- as four of the justices wanted to do, in its entirety -- we would have faced utter chaos, economically, systemically, and politically. The price of insurance would have soared, fewer and fewer people would have been able to afford it, tertiary care hospitals and emerging integrated care networks would have faced ruin. At least now we can try to take some steps forward.

But this is not the end, or even very much progress. It just makes it possible to fight on.

What's it going to take?

I mean come on now. What has to happen to chase the global warming denialists back to the 9th circle of hell from which they came?

Would the west erupting in an unprecedented conflagration amid relentless record high temperatures convince people?

How about record lows in the extent and volume of arctic sea ice, year after year?

The ongoing collapse of the ice shelves along the Antarctic peninsula?

The earliest date that four tropical cyclones have formed in the Atlantic since records began, including a hurricane that formed at 40 degrees lattitude in mid-June?

The Midwest swinging wildly between destructive floods and exterminating drought?

What's it gonna take? Maybe we'll find out very soon, but evidently we're going to have to find out the hard way.

What Michael Tomasky Said . . .

Specifically, what he said here. It is simply baffling to me how BHO, democrats, and advocates for health care reform generally have utterly failed to defend, or even explain, the affordable care act. The act, according to pollsters, is unpopular. The people know they're supposed to hate it, but they don't know why. They don't even know what's in it.

When you ask them about specific stuff that is in it, they generally like each of the pieces, usually by a lot. What they mostly don't like is stuff that isn't in it. It is not a government takeover of health care. It does not include death panels, or rationing. It will not put a bureaucrat between you and your doctor. It will not restrict your choice of insurance plans. On the contrary, it will do exactly what Mitt Romney says he wants you to be able to do -- it will make it much easier, if you don't like your insurance company, to fire them and get a different one.

It will make it possible for people who cannot under any circumstances buy affordable insurance now get insurance and get their medical needs taken care of. It will make insurance companies take less of your premiums for profit and marketing and executive salaries and paying people to figure out how to deny you coverage or specific benefits; and put more of your money back into your health care. It will make it easier to compare insurance plans and pick the one you like. It will guarantee you a minimum standard of benefits. If you have a low or moderate income, it will give you a subsidy to make insurance affordable. And on the whole, in total, in the long run, it will create the kind of system we need to actually save money. (Alright, what I want is a single payer system that will do that for real, and now, but this is Earth One.) And so on.

Yes, apparently the majority of people don't like the individual mandate but it might help if somebody explained it to them. Right now, people who don't have insurance, if they get really sick or hit by a bus, show up at the ER and we all have to pay their medical bills. This is about personal responsibility -- the purpose is to put a stop to freeloading. That's conservative, and libertarian, and darn well right wing.

So why can't people stand up in front of a TV camera and just say all this? There is some kind of weird collective aphasia in the Democratic Party.

Speaking of evil bastards . . .

I found in my mailbox a letter from some people who call themselves "Lifeline Screening." They are going to be in my area for one day only, and for $60 they'll do an ultrasound screening of my carotid arteries. They'll also do various other screening tests if I fork over even more dough.

As they explain, my insurance will not pay for this, which is too bad because, if I want to know "Who needs to be screened?" the answer is, "[A]nyone over 50 who wants to be proactive about his or her health." They go on to tell me that my risk of stroke doubles each decade after age 55, but "my doctor won't order these screenings -- and insurance won't pay for them -- unless you have symptoms."

Wow, my doctor isn't look out for my best interests! Neither is my insurance company. It's a good thing these folks came long to save my life.

Oh wait a minute. Here's what the U.S. Preventive Services Task Force has to say:

The USPSTF recommends against screening for asymptomatic carotid artery stenosis (CAS) in the general adult population. (This is a grade "D" recommendation)

And why might this be. Does the USPSTF, along with my doctor and my insurance company, want me to die or be paralyzed from a stroke? Actually no, they don't. Here's some of what else they have to say:

Good evidence indicates that although stroke is a leading cause of death and disability in the United States, a relatively small proportion of all disabling, unheralded strokes is due to CAS. [I.e., carotid artery stenosis, the problem for which these people propose to screen me.]

Benefits of Detection and Early Intervention. Good evidence indicates that in selected, high-risk trial participants with asymptomatic severe CAS, carotid endarterectomy by selected surgeons reduces the 5-year absolute incidence of all strokes or perioperative death by approximately 5%. These benefits would be less among asymptomatic people in the general population. For the general primary care population, the benefits are judged to be no greater than small.
Harms of Detection and Early Intervention. Good evidence indicates that both the testing strategy and the treatment with carotid endarterectomy can cause harms. A testing strategy that includes angiography will itself cause some strokes. A testing strategy that does not include angiography will cause some strokes by leading to carotid endarterectomy in people who do not have severe CAS. In excellent centers, carotid endarterectomy is associated with a 30-day stroke or mortality rate of about 3%; some areas have higher rates. These harms are judged to be no less than small.

In other words, LifeLine Screening is a scam. They are grifters. Keep your wallet in your pocket.

An interesting review

As part of the New England Journal of Medicine's 200th birthday celebration, David S. Jones and colleagues review what I will summarize as the social context of medicine since the journal was founded. The mix of actual physical problems that people bring to doctors has changed considerably over that time, but so has the way in which they are classified, interpreted, and responded to.

The authors present, without much comment, the pervasiveness of racist and eugenic ideology in the profession in years gone by, particularly late 19th and early 20th Century. Also of interest are the problems of disease labeling -- which again, they present but don't discuss in any depth -- and the question of the importance of medical intervention versus social determinants and public health measures in creating population health.

For all its continued faults and limitations, medicine has gotten better over the years. Sure, there are still racist and arrogant doctors, but the normative ethics of the profession have evolved to very clearly demand respect for the worth, dignity and autonomy of every patient. Medical practice is not yet fully based in evidence and science, but it's one hell of a lot better than it was just 50 years ago. When I was in graduate school there was still a legitimate argument about whether medicine contributed more than bupkis, or maybe anything at all (viz. Ivan Illich) to the health and welfare of the population. No more. We waste a lot of money on overdiagnosis and overtreatment, but the net contribution of medical intervention to our health is huge.

And that''s why the problem of universal access is urgent. Medicine has gotten a lot more expensive, so that lots of people can't afford it; but it's also gotten a lot more worthwhile, so that denying it to people is equivalent to letting them starve or freeze to death. But, unlike food and shelter, the need for medical care that any given person has at any given moment varies radically, essentially infinitely, and generally for no fault of their own.

That is why I find it beyond outrageous that the rich, ignorant clowns that the rich, ignorant Bushes appointed to the Supreme Court are going to invent some preposterous legal rationale just to deprive a Democratic president of a policy accomplishment that Republicans supported eight years ago. If they put together 5 votes to do that, the legitimacy of the court will be destroyed along with our constitutional republic. Evil bastards.

The shallowness of profundity

I don't know how many of you kids are old enough to remember postmodernism, but basically it was an academic movement that claimed, in essence, that objective reality was a form of oppression. Obviously, once you and your pals agree that there is no such thing as a criticizable truth claim, you can pretty much spout any old gobbledygook you want to, and get a tenured professorship in return.

Some clever geeks wrote a computer program that generates postmodernist essays that are just as good as the ones generated by humans. You get a new one every time you go there, so I'll give you a snippet of the truly awesome one I just got:

If one examines postpatriarchialist socialism, one is faced with a choice: either accept prepatriarchialist conceptual theory or conclude that the collective is capable of social comment. Brophy[1] implies that the works of Rushdie are reminiscent of Koons. In a sense, the subject is interpolated into a neostructuralist paradigm of discourse that includes truth as a paradox.

Riding in the wake of postmodernism comes the New Age pseudo-philosopher and quack doctor Deepak Chopra, and guess what! He's been replaced by a computer too. His latest message to me is "The unpredictable creates deep facts." Now that's heavy.

Blowback . . .

Possibly the worst ever. And it's really disturbing how the corporate media have buried this story -- of course the editors and reporters don't have much judgment about what really matters. Pakistani Taliban leader Hafiz Gul Bahadur has announced a ban on polio vaccination in North Waziristan until the CIA aerial drone attacks in the region stop. UNICEF was about to launch a vaccination drive tomorrow.

I've written about this quite a bit here before but just to review, we are very close to eradicating polio from the earth. This would be the second infectious disease of humans, after smallpox, to be eliminated. I'm just old enough to have had a classmate who walked with braces and canes, and a little girl in my neighborhood who couldn't walk at all, because of polio. Even less lucky people were dependent on ventilators, or dead.

Polio still exists in three countries -- Pakistan, Afghanistan, and Nigeria. If we keep at it, we can wipe it out in a couple more years. But if we fail, we could have a global catastrophe. Most children, in places where there is no exposure liability, are no longer protected against polio. If the disease gets loose on a large scale, we'll have to start vaccinating everybody, everywhere, and in the meantime there will be lot of people paralyzed and killed.

Yes, these attacks kill combatants, but they kill lots of other people too. And they make more enemies than they kill. Now maybe they'll end up killing thousands of children. Way to earn that Nobel Peace Prize.

A meaningless distinction

That would be the question of whether Anders Breivik is insane. Like Ted Kackzynski, he very much wants you to know that he is perfectly sane, although maybe you don't happen to agree with his philosophical and political wisdom. In TK's case, the result at stake was whether he would be injected with lethal poisons or locked up for the rest of his life. In AB's case, it is precisely where he will be locked up. I suppose these questions matter, but the criterion is just silly.

Nobody actually knows what "schizophrenia" is in the first place, or even whether it is a single entity. Very likely it is not, and one way to tell is that anyone who wants to claim that either Breivik or TK has schizophrenia has to claim that he has a special kind in which many of the characteristic symptoms of the disease are absent. But really, who cares? If you don't want to call either of them schizophrenic you can give them some other disease label by virtue of their deviant behavior -- let's say sociopathy -- and inflated opinion of their own importance -- say narcissism. But it appears that the diseases of sociopathy and narcissism don't get you off the criminal hook, while schizophrenia does. Why is that?

If you want to label them as delusional you would have to claim that believing that industrial civilization has been disastrous for humanity, or that Norwegian culture is being degraded by immigrants, is delusional, but that would cover a whole lot of people who are neither criminals nor likely to be considered insane. Alternatively, you could claim that the belief that mailing out bombs or shooting participants in a political party youth camp would help bring about a desired political outcome is  delusional, but that would mean that anybody who engages in similar actions is ipso facto delusional, which means that nobody who does such things can be culpable.

The fact is that for all of us, free will is an illusion. The brain produces behavior; and the development of the brain through the interaction of genetic endowment with the life course of physical environment and social experience produces the state of the brain that produces said behavior. Claiming that one person is culpable because of the specific -- although not actually well-defined -- state his brain happened to arrive at, while another is not because of some different brain state, is just silly. It's a category error.

Time to see if I can qualify for Irish citizenship

Honestly folks, if if one schtickdreck is openly boasting that he's going to donate $100,000,000 to get Mitt Romney elected president, we do not live in a Republic. Notice, by the way, that this man is a total idiot. His reasons are that a) Barack Obama is a socialist and we're now living under socialism and b) Barack Obama is insufficiently friendly to Israel. In other words, it is loyalty to a country other than the United States, along with paranoid ignorance, that motivates him. Many people are trying to say, don't worry about it, spending all that money isn't going to work. Sorry to have to disagree -- it'll work just fine. Remember that it doesn't just buy advertisements, it buys the corporate media that get paid to carry the advertising. And it isn't aimed at you, all smart and well-informed and capable of seeing through the bullshit and hey, you don't watch TV anyway or at least you skip the ads. It's aimed at the people on whom it does work, and there are plenty of them. Hell, some of them are even as stupid as Sheldon Adelson. Tell me why we aren't completely screwed. I'm listening.

Not that I have anything highly original to add . . .

to what most people are already thinking about the stomach churning story coming out of Happy Valley, but there are some important lessons here. Philly.com is providing comprehensive coverage of the Jerry Sandusky trial and it appears the testimony is so disturbing that the university figured this was a good time to distract attention from the trial by publicly throwing its former president under the bus, releasing e-mails showing that yes, he did know about and choose not to report allegations about Sandusky because it wouldn't be "humane." Oh yeah, his last year on the job they paid him more than $1 million because, you know, it's hard to find competent leadership.

Okay, that's not exactly a distraction, but evidently they're trying to let the public know at this moment that the institution is all reformed and they're all good guys now. Whatever.

The fact is that Penn State football was an elaborate fairy tale. The entire vast institution of the university was built around it -- the demigod Joe Paterno and the generations of mythic heroes, pure of heart, mighty of sinew, imbued with noble tradition, who yearly rallied 'round the glorious banner of PSU. It was the fairy tale that brought in the millions in contributions, gave the local community its identity, and put PSU on the map. (It happens to be a great research university but ironically, people tend to think it's just a jock school.)

So, I guess president Graham Spanier just thought he couldn't afford to wake his kingdom from the dream. When it finally came, it was much, much worse.

The worst news ever?

According to a recent Gallup poll, the proportion of Americans who believe that God created humans in their present form within the past 10,000 years has actually bumped up recently, to 46%, about where it's been for decades. This is incredibly sad. In order to believe this you need to be ignorant not only of biology, geology and physics, but of history and indeed of simple common sense.

I had long presumed that generational change would push those numbers in the right direction -- that as people who grew up ignorant died off, better educated younger generations would steadily make acceptance of evolution pervasive. That the opposite is happening is deeply disturbing. Our schools are failing utterly, and so we have no future. People can now leave school rejecting overwhelming empirical evidence for incontestable fact, choosing instead atavistic ideology that survives only as a marker of tribal identity. And that has given us our utterly dysfunctional politics, where the multiple crises that confront us are met by the opposite of rational response.

Here's a very long post  from Brad DeLong on Tom Mann and Norman Ornstein discussing their new book about the Republican Party. Quoth Ornstein:

Now, one interesting question is how much can you hold together those private factors and you begin showing things that clearly cut directly against the interests and desires of their own constituency. Most of them have no clue what the government does. And if you think about it, you know, the Tea Part has a lot of older voters who don’t understand how this will affect them. Just to pick one example, cut Medicaid by 30% and eliminate the state and local tax deduction and then think about who is in a nursing home. Now they will still be in a nursing home, there will be one nurse’s aide for every 25 patients instead of one for every three, so you will never be seen. You will ring your little bell, and four days later somebody may stop by and say "oops, let’s remove that one, we are going to need another patient for this bed."

Maybe you don't see the connection, but I do.

Headlines

With 7 billion people on the planet, there are going to be a few serious weirdos. If one in a billion kills guys and mails their body parts around, kills and eats his roommate, or eats a guy's face, you're going to have an example here and there. On the other hand, your personal chances of having it happen to you are, under my stated assumption, one in a billion. Even if it's one in 10 million, is it really more important than the collapse of planet's marine and terrestrial ecosystems and the destruction of civilization?

Just wondering. Your editorial judgment may differ.

Observational Studies, Part 2

We've been handed a teachable moment by the study reported in The Lancet finding that exposure to CT scans in childhood is associated with an increased risk of cancer later in life.
This is called a retrospective cohort study. It would be impossible to do this particular study in the United States, because of our fragmented health care system. In the UK however, they do indeed have socialized medicine. While this means that Britain must be a totalitarian dungeon, it also means that they have universal access, much lower costs, and better outcomes than we do. Also the people are more satisfied with their health care. I know, The Horror, The Horror!

It also means that it is possible to link events that befall specific people at one time in their lives with their later fate. Since everybody gets their health care from the National Health Service, the records are available for every single child who had one or more CT scans. The study (by Mark S. Pearce and colleagues) included every person who did not have a prior cancer diagnosis, who had one or more CT scans while they were younger than 22 years from the years 1985 through 2002. The UK also has a central cancer registry, so it was possible to identify all of these individuals who were subsequently diagnosed with cancer in the years 1985-2008. Again, this could not be done in the United States. Finally, they developed models for total radiation exposure to the brain and bone marrow based on which body parts were scanned and the age at which it happened. This enabled them to calculate a dose-response relationship between exposure to these tissues, and subsequent blood (leukemia) and brain cancers. Because the radiation dose to bone marrow and brain from scans of the extremities is at or near zero, this gave them what amounts to a non-exposed comparison group.

The net result is a study that is in many respects as good as a Randomized Controlled Trial (info to follow in a few days). The investigators excluded leukemias that appeared within 2 years of the scan, and brain cancers that appeared within 6 years, so as to eliminate the possibility that the scan was done because of suspicion of cancer. That means that as far as we can tell, the exposures were random with respect to cancer risk. (They would typically have been done because of a traumatic injury, or abdominal pain.) The diagnoses of cancer were made by physicians who had no idea this study would ever happen and most likely did not even know that the scans had ever taken place, so it qualifies as blinded; and in any case diagnoses of leukemia or brain cancer are pretty definitive and unlikely to be much influenced by ascertainment bias.
The results are additionally compelling because there is a very pretty, linear dose-response relationship for both categories of cancer; and because the results are similar to what has been found from other observational studies such as observation of Hiroshima survivors. So this gives very strong support for causal inference.

Caveats? A couple. I said "almost as good as an RCT" because it is possible to imagine some confounders. Actually I don't think the authors even mentioned this, but head trauma is an indication for a head scan, obviously, and could plausibly be related to later risk of brain cancer. Similarly, one can imagine that there is some as yet unrecognized relationship between causes of abdominal pain or intestinal symptoms in children and later leukemia. One could also imagine that there are certain socio-economic or environmental circumstances associated with the probability of receiving a CT scan in childhood and cancer risk. However, the linear dose-response relationship would seem to argue against these possibilities.

The good news, for those of you who are now paralyzed in fear because of that abdomen scan they gave you when you had suspected appendicitis, is that the relative risk reported in the corporate media -- 3 to 7 times for the highest doses, for leukemia and brain cancer respectively -- actually represent very low absolute risk. By 10 years after exposure, you would expect one case of leukemia and one brain tumor per every 10,000 patients. Unfortunately the elevated risk, as far as we know, continues after that, probably for life, but it still adds up very slowly. One more takeaway -- an I'm volunteering this one -- this study does support the widely used assumption that there is no safe threshold for radiation exposure, that the risk for cancer is linear and that the line goes right through zero. But -- the risk at low levels is extremely small.

Finally, obviously, this is one more cautionary tale about overutilization of medical procedures. CT scans are still well worth doing under some circumstances. They are actually much safer than, say, riding in a car every day. And wouldn't you want to know if your child had a cerebral hemorrhage that might kill her? Say, because she'd been in a car crash? But, make sure there really is a darn good reason.

News update on the antibiotic resistance front

Sorry to have skipped for a couple of days, but I had a RTI -- that's a respiratory tract infection, or, to put it in English, a cold. I was at a conference in Miami, no less, and I had to at least minimally discharge my responsibilities in attending sessions where my work was discussed and presenting a poster. However, I was absolutely miserable and had no energy to do blog posts.

Do not grieve -- I'm feeling much better already. Many people in my situation go straight to their doctors and ask for antibiotics, and for reasons even I, who study physician-patient communication for a living, and not sure of, the doctors often comply with the request. This is a very bad idea because it is extremely unlikely the antibiotics will do the people any good - they have a viral infection - while misuse and overuse of antibiotics are threatening a global catastrophe.

One of many early warnings we're getting right now -- in addition to extremely drug resistant tuberculosis and methycyllin resistant staphylococcus aurea -- is drug resistant gonorrhea. This basically comes about because people receive inadequate courses of antibiotics, a function mostly of poor quality health care or over-the-counter dispensing of medications in low resource settings. The linked article from MSNBC says "Experts say the best way to reduce the risk of even greater resistance developing - beyond the urgent need to develop effective new drugs - is to treat gonorrhea with combinations of two or more types of antibiotic at the same time." That's sorta kinda true, but actually the best way is stop transmission in the first place by getting people to always use condoms. Which would also stop the HIV epidemic dead. Sigh. Not going to happen I expect. Ratzinger says it would be immoral.


On a happier note, I think you may only be able to read the first 150 words, but JAMA reporter Bridget Kuehn has the latest on FDA efforts to reduce use of antibiotics in animal feed. (I rooted around for a bit in the FDA web site but I couldn't track this down.) Unfortunately they are issuing "guidelines" for livestock producers to eliminate routine use of antibiotics in animal feed, rather than regulations. They figure, it they try to regulate, they'll get sued and it will take 20 years to work it out. So they're going with the voluntary guidelines. They are hopeful that the industry will think this is a great idea and go along with it. I'm not holding my breath but at least there is now some statement from the government that this will be in the public interest. Maybe that will help.

Meanwhile, if you come down with a cold, don't ask your doc for antibiotics.

Leavin', on a jet plane

I'm headed to Miami today for the International Conference on HIV treatment and prevention adherence. I'll let y'all know what interesting stuff I learn there.

My own little presentation has to do with differences in provider-patient interactions depending on the patient's race/ethnicity. It's not super-dramatic, but basically, there is more talk about medication adherence with Black and Latino patients, regardless of whether they have suppressed viral loads or say they are taking their pills; Black patients talk less overall; and there is less humor and empathic utterances by doctors with Black patients. This is based on my analysis of 415 recorded routine visits at 4 different clinics around the country. Don't know if it means a whole lot, or what exactly it means, but it's at least suggestive.

I'll keep you posted.

While you were being titillated . . .

. . . by the endless, wall-to-wall yet largely content-free coverage of the shocking, shocking fact that some secret service agents and military security guards like to party while they are on assignment abroad, there was in fact a summit of the Americas happening in Cartagena. The corporate media didn't bother to cover that, presumably because there was no sex involved.

Fortunately, we have Alma Guillermoprieto to reveal the secret of what happened at the summit. It seems there was an uprising by the leaders of just about all the Latin American countries against the war on drugs. This policy, launched by Richard Nixon (who was fond of wars on this and that) has pretty much been serially destroying the nations of this hemisphere. It also has done absolutely nothing to control drug abuse in the U.S. or anywhere else, although it has filled our prisons with Black and Latino men (even though white men are more likely to use illegal drugs.) It is unquestionably a colossal, horrific, atrocious failure.

However, we aren't allowed to talk about that stupid fact. Obama obviously couldn't do anything in an election year but tell them to fuggedaboudit. We're going to keep on fighting this war to the last Mexican and Honduran. Because, because, well, because it's DRUGS, that's why.

I urge you to read Guillermoprieto's piece, and then let's all get together and think of a better way.

All's Not Quiet on the Less-is-more Front

Coming next year -- yes, the wheels of science grind slow, but they grind fine -- the Preventing Overdiagnosis Conference. Overdiagnosis means that people who have some condition that will never harm them get a disease label and, almost inevitably, treatment. Said treatment is at the very least costly, quite likely harmful, and the person must live with an unsettling and possibly even stigmatizing consciousness of being sick, or "at risk."

Overdiagnosis comes from screening that can't discriminate well between dangerous and harmless lesions. Examples are mammography for breast cancer, and PSA for prostate cancer. Those have been much belabored here. It also happens when the threshold for declaring that a "disease" exists is set too low, so that on average the costs of treatment outweigh the benefits. We may have done this with high blood pressure, diabetes, and kidney disease. And it happens when we define diseases that may not even exist, or for which the cure right now is worse than the disease. I'm tempted to put Attention Deficit-Hyperactivity Disorder in that category, and probably pediatric bipolar disorder. That would be a controversial position but I'm not alone.

The fact is that the incidence of cancer has been rising for decades, but the death rate has not fallen much. That is pretty much prima facie proof of overdiagnosis. Lots of old folks are put on dialysis who really don't need it, and they actually die sooner than people who are not. (Renal function declines as we get older, but the rate of decline is much slower than it is in people who really have kidney disease.)

Many people have been found to be using inhaled corticosteroids, for asthma, and antidepressants, who do not actually meet diagnostic criteria for those diseases. I'm not sure whether "overdiagnosis" is the right word in these instances, because they often don't even have a diagnosis in their medical record. They just have a prescription.

Now here's the thing. This is wasting something like 20-30% of all the money spent on health care in this country. Money that could be spent providing access to actually needed health care for people who don't have it. But when we try to do something about it, we get mobs screaming about death panels and pointy headed bureaucrats coming between us and our doctors. We need to ignore those people, and fix this problem.

Observational studies, part 1

Continuing with this series -- which I'm sure Steve Novella would agree is worth doing -- we'll step away from experimental designs for a bit to discuss observational studies.

Most epidemiological research is not based on experiments -- in which we deliberately take some action (called an "intervention") to see what happens. It's just highly structured observation of the world as it is. The simplest case is a cross-sectional study in which some number of subjects -- in our field, that ordinarily means people -- are observed in the same manner. They may be given a questionnaire; or have some biological measurements taken, such as their height, weight and age; or both.

Public opinion surveys and electoral polls are also examples of this kind of study. Most people have some idea behind the mathematics that allows Gallup to predict the votes of millions of people by talking to a few hundred, but let's review very quickly. (You can read my more extensive entries on this subject here, here, here, here, here, and here.)

If you have a way to pick people at random from all the people you are interested in -- that's called the people who constitute your "universe" -- such as eligible voters, then you can use certain mathematical techniques to figure out how similar your sample is likely to be to that "universe." Specifically, you can calculate a probability that the percentage of people in the universe who have a given characteristic is different from the percentage of people in your sample by any given amount. (See the links above if you want more info about how this works.) When they talk about the "margin of error" of a poll what they normally mean is that 95% of the time, the real number in the universe will be inside it. That 95% is arbitrary, but it's taken on sacred status. The most likely real number is the actual number in the poll; we could report the 67% confidence interval or any other interval we wanted to. But 95% it is.

But there is a lot that can go wrong with polls, or any study of this sort, other than just happening to talk to an unrepresentative sample. We could have a bad sampling "frame" -- the classic example is, we think we're picking at random from all the likely voters, but we're only talking to people with telephones, and Dewey Beats Truman! Nowadays almost everybody has a phone so that isn't really a problem, but maybe some kinds of people don't generally want to talk to us. That's called selection bias. Or maybe some kinds of answers are stigmatized, which is why few people will tell a pollster they wouldn't vote for a black person.  That's called socially responsible response bias. (Atheists, however, are another matter.) Or maybe you asked the question in a way that pushes people toward a particular answer.

In epidemiological studies, we're often interested in whether past events or exposures are associated with current health problems. For example, are people's diets associated with, oh, high blood pressure, or whatever. Here you have problems with recall. Can you tell me what you ate for lunch last Wednesday?

There is a great deal more that I could say about this but I'll just leave you with one essential point. Even if we do everything very rigorously and our observations really are representative of the population of interest, associations in any cross sectional study cannot prove causation. People who eat a lot of mangoes may have lower blood pressure than people who do not for reasons having nothing to do with mangoes. Maybe they are of different ethnicity, different socio-economic status, live in different places, have other dietary differences we didn't measure, exercise more -- who knows. We can try to control for all those factors but we can't control for anything we forgot to ask about. If we want to make causal inferences, we have to do something else.

More on evidence

Continuing my latest adventure in wonkery, the quick review of the evidentiary basis of causal inference . . .

The plural of anecdote is "anecdotes," not "data," it is true -- however, anecdotes are data.

But, the term anecdote connotes a story that is only casually observed, perhaps retold. Both single case studies and so-called within subjects design studies can provide useful information and can even support causal inference under very specific circumstances, although it is unlikely to be conclusive; but we must very carefully observe and document what we do. That's why these aren't considered "anecdotes." The reason we often see highly dismissive responses to such studies is that they are often overinterpreted, their limitations insufficiently acknowledged. Indeed they are quite commonly used by charlatans such as homeopaths to promote quackery. But let's hang on to the baby as we pour out the bathwater.

To review, if an outcome is extremely improbable, and we try a novel intervention even once and then observe the extremely improbable outcome, we can reasonably have a strong suspicion that the intervention was indeed related to the outcome. If we have an a priori plausible explanation for how the intervention produced the outcome, so much the better. So, if surviving a fall from thousands of feet is highly improbable, and a person using a parachute survives such a fall unscathed, we don't need to see it work more than once to believe that there's something to this parachute thing.

On the other hand, a single trial would not convince us that parachutes work 100% of the time, or even most of the time. We'd need a lot of experience before we were confident we knew how effective parachutes are, under what circumstances, and what can go wrong. What we would not need, however, is a randomized controlled trial, because we are already highly confident that falling 5,000 feet without a parachute is almost inevitably fatal.

And that's the principle on which a within subjects design can be useful. If we're already confident that a particular outcome in a defined population is improbable given the existing or natural state of affairs, then a before-and-after test of an intervention can give us meaningful information about whether it is likely to be effective. If remission of metastatic cancer is extremely rare, if we give 5 people a novel treatment and 3 of them remit, we don't need a formal control group to believe we're on to something.

This sort of inference depends on the assumption that people are biologically pretty similar. After all, a chemistry experiment doesn't ordinarily need a control group at all because every atom of a given isotope of carbon, in the same state of ionization, is identical. The reason we have much more difficulty making causal inferences in health research is because people are so complex and so variable; because measurement of outcomes is often not straightforward; and because out interventions, unlike mixing chemicals in a beaker, typically have multiple components and multiple effects.

And so, the example with metastatic cancer is quite unusual. If an outcome, unlike remission of metastatic cancer, is not extremely rare, is not completely straightforward to observe, or may respond to multiple components of the intervention such as placebo effect, a within subjects trial is much more problematic. Sure, if the trial results in a rate of outcome which is markedly different from what we would have expected, it can be at the very least suggestive, but there are many pitfalls.

Here are a few:

Selection bias: People are convinced that Alcoholics Anonymous works because alcoholics who regularly attend AA meetings have a higher rate of sustained abstinence than alcoholics who do not. But maybe people who are motivated to remain abstinent are more likely to attend meetings. In fact there is no good evidence to show that AA is effective at all, for basically this reason. Should we really expect the desired outcome to be at the ordinary background rate in the population selected for the trial, or is just selection, rather than the intervention, that produces the observed effect?

History: Before and after designs are often used for interventions that target social problems, perhaps at a community level. But the trouble here is that a whole lot else is going on at the same time, in addition to the intervention. While you're doing outreach education to reduce the risk of STIs in teenagers, a whole lot else may be changing: sexual mores, condom availability, the likelihood of exposure due to other factors such as enhanced availability of treatment, you name it.

Non-specific effects of the intervention: We may attribute the observed outcome to the magic potion we had you ingest, but maybe it was the effect on your expectations, the fact that it made you mildly nauseous so you skipped your usual seven vodka-and-ginger ales, or just the fact that somebody paid attention to you, that made the difference. Notice that this category includes, but is not strictly limited to, what we call placebo effects.

So, uncontrolled, before-and-after trials, can give us some useful information but they can also often be misleading. So-called Phase One trials of drugs are of this nature. A small number of people are given an experimental drug just to see if there are any obvious, immediate ill effects; so we can figure out it's "pharmacokinetics," in other words how much of the stuff gets into the blood stream or target tissues and how long it lasts; and to see if anything else dramatic and exciting happens. If the latter, we don't jump to any conclusions. We still need to go no to controlled trials before the drug can get approved.

New Windham County Post

I'll be getting back into it. Sorry for the long hiatus.

Evidence

A couple of questions from commenters have inspired me to produce a bit of a primer on the kinds of evidence we use in health research. It seems to me that a lot of the political controversy over health policy and official recommendations is fueled by limited understanding of the use of evidence to make causal inferences. As I set out on this project I really have no idea how long it will take. We'll just see what happens.

Categories of evidence are commonly organized in a hierarchy, with some kinds said to be stronger or more compelling than others. I don't exactly look at it that way. Different kinds of evidence are useful in different situations and lead us to different kinds of conclusions. Just as important, how we regard any kind of evidence must depend on the prior plausibility of what it seems to show. If there is already very strong evidence for or against some conclusion, then any new evidence that contradicts what already seems highly probable is less compelling, and we should be much more diligent in looking for flaws in the study or concluding that chance alone is responsible for the observations.

This is different from confirmation bias, which is a feature of human cognition in which we tend to ignore or explain away evidence that contradicts what we already believe. We should certainly take surprising findings seriously, but we should subject them to careful scrutiny. If they do compel us to re-examine our prior beliefs, we should certainly do so. I will address these issues a bit more formally as we go along.

Alright. As most people know, conventionally anecdote is presented as the least convincing kind of evidence. An famous example of anecdotal evidence is the putative association between vaccination and autism. Parents see their child receive a shot, and some time not long after they start to see developmental regression and symptoms of autism. Unfortunately, some parents have an unshakeable conviction after this experience that the vaccine caused the autism. As I'm sure most readers already know, this is a common fallacy called post hoc ergo property hoc, because if you say it in Latin you must be really smart. I think if we started naming it in English we would still be just as smart, so I'll call it after this, therefore because of it.

While overwhelming, really incontrovertible evidence of much greater force has shown that vaccination does not cause autism, it is wrong to say that anecdotal evidence is worthless in general or should be ignored. A famous example is the efficacy of parachutes. Since we know that falling from 10,000 feet is invariably fatal, seeing a person do so with the aid of a parachute and land unharmed, even once, is extremely compelling evidence for the efficacy of parachutes. Not only has something obviously extraordinary happened, we can immediately see how it apparently works: by air resistance. The scenario makes perfect sense: it has high prior plausibility. Seeing it happen once wouldn't necessarily make me confident enough to strap on a parachute and jump out of an airplane; but it would make me believe that if the equipment were sufficiently reliable, and weather and other conditions similar to those pertaining to the observation, the parachute would be highly likely to work.

To return to the case of autism, suppose no child had ever been vaccinated and no child had ever been autistic - or at least that autism was extremely rare. If the first child ever to be vaccinated subsequently became autistic, we would properly have a very high index of suspicion that the events might be associated. If we could think of a highly plausible biological mechanism, our suspicion would be even stronger. Neither of these requirements holds in the real case, however.

Moving along, although it is often said that the plural of anecdote is not data, this is certainly false. Data is a synonym for information, and the more anecdotes, the more information. In fact the plural of anecdote can be organized formally into a kind of study called a within subjects design. I'll talk about that in the next installment.

The world turned upside down

I would not have predicted this, even five years ago. Hell, even last year. WaPo poll says 54% of voters think gay marriage should be legal -- and that's using the word marriage, not civil unions. What's more, 39% "strongly" agree, compared with 30% who strongly disagree.

For sure, the culture changes over time. But the stigma of homosexuality was so profound, so widespread, so ancient, that such a seismic collapse seemed inconceivable. The first legal recognition of slavery in what was to become the United States occurred in Virginia in 1654. It took more than 200 years and a horrific war for slavery to end in the United States, and another 100 years before African Americans received full legal recognition of equality. (Of course, that's still only on paper, as the composition of our prison populations attests.)

It will be a few more years, to be sure, until lesbians and gay men achieve legal equality, but just think -- when the Mattachine Society was founded in 1950, its membership was secret and the name referred to a French tradition of performers who never appeared unmasked. Homosexuality was a crime in much of the United States until 2003. The new poll shows a nearly 20 percentage point  increase in support for gay marriage in just a few years.

The Republican party successfully used gay marriage as a wedge issue to drive voters to the polls in its favor right through the 2004 election. Believe it or not, in the face of this tectonic shift, support for gay marriage among Republicans has actually declined. But it won't work in the party's favor any more.

Astonishing.

Like I've been saying . . .

The U.S. Preventive Services Task Force has held its ground on prostate cancer screening. They are against screening, for men of any age. And yes, the howls of outrage are echoing through the hospital and clinic halls, notably from the American Urological Association. Now I wonder why the AUA is "outraged"?

Ah. I have a thought. They make money by treating prostate cancer, and they make even more money by treating the incontinence and erectile dysfunction that results from the treatment. Here's what the USPSTF says, and it's not outrageous:

1. The number of men who would have died of prostate cancer within 10 or 14 years (the follow-up time of the available studies), but who will not because they are screened, is possibly zero and no more than 1 out of 1,000. 
2. 80% of positive PSA tests are false positives, but these false positive tests are followed by biopsies which in 1/3 of cases result in pain, fever, bleeding, infection or other problems that require further medical intervention. 
3. 90% of men with positive biopsies will get treatment with surgery, radiation, or drugs to suppress their androgen. Five out of 1,000 will die within a month of surgery, and from 10 to 70 more will have severe complications. Twenty to 30% of them will have incontinence and/or erectile dysfunction.
4. However, many of them -- probably most of them -- would never have died from prostate cancer even without treatment, because most of the "cancers" found on biopsy would never have progressed to cause disease.

So it's a no-brainer. Men who have been through this are convinced that it saved their lives, because who wants to admit that they went through all that for nothing? The doctors who treat them don't want to admit that they have been paid big bucks to harm people all these years either. And all the celebrities who made PSAs to promote PSA don't want to think they've been tools either.

By the way, there's no evidence that screening just by digital rectal exam is worth it either. I'm certainly not going for it.

Yet one more study showing that reality has a liberal bias

Yeah yeah, it's getting old. Analysis of data from the General Social Survey (an ongoing project of the National Opinion Research Center, and no, it is not a government agency) shows that since 1974, trust in science among conservatives has fallen by 25% -- and it's specifically among people with college degrees no less. Conservatives used to have the most trust in science, now they have the least.


Why? Because scientific truth is inconsistent with conservative ideology. That is all.

I can't believe this is even controversial

The presidential campaign this year is essentially a contest between semi-sanity and florid psychosis. Apart from the side shows about whether Mitt's tenure at Bain Capital produced a net gain or loss of jobs, and whether Obama is a "real" American, the substantive issues at stake are principally:

1. Should the government regulate banking and finance, or does removing the oppressive hand of the state liberate capitalists to create wealth and jobs?

Mitt -- what planet do you live on? Have we already forgotten what happened in 2008? Here's a view from the land of bangers and mash that would be a voice crying in the wilderness here. The "Free Market" you worship is a fiction. Markets in complex societies are not forces of nature, they are creations of the state. They cannot exist without continuous, fundamental government intervention. The only question is how they will be regulated, on whose behalf. You want to regulate markets for the benefit of a fraction of one percent of the very wealthiest people. And no, they are not job creators nor will increasing their wealth at the expense of the rest of us somehow make us better off in the end. That is utterly preposterous. Astonishingly, half of the voters seem to believe it.

2. Should government take action to protect the planetary environment? Or is environmentalism a scam to suck up grant funding and impose socialist tyranny?

The truth is starting to penetrate even people coal country.  But here's the really bad news: We may be facing an immediate planetary emergency as methane outgasses from the melting arctic. The most terrifying crisis in human history -- at least since our ancestors passed through an unexplained population bottleneck 2 million years ago -- is not even an issue in the campaign. Never mentioned.

3. Should we forbid women to control their own reproduction because God says so?

Actually, it isn't God, it's a few depraved, ostensibly celibate old men wearing medieval costumes, and some con artists sucking up millions of dollars from suckers. God apparently didn't get around to saying this until approximately the late 19th Century,  because there is not one word about abortion or contraception anywhere in the Bible, Old Testament or New. This ought to be embarrassing to the preacherly grifters, who can find verses in Leviticus telling us to stone homosexuals to death. (Somehow they skipped the ones about driving people with rashes into the desert to die).

And yet, Republicans can actually win elections with this crap. If it happens in November, we are doomed.

The World's Most Popular Fallacy

Or at least I think it probably qualifies. That would be conflating association with causation, and it's a plague (hah!) in public health research. Today's entry is the so-called "good cholesterol" hypothesis. Or at least, it should have been considered a hypothesis all this time, but instead people have treated it as a finding.

The linked article may be a bit esoteric. It has gotten some coverage in the lay media, but I'll offer my own summary. Most people have heard that "high cholesterol" is a risk factor for heart disease and strokes, but that there are actually two kinds, called Low Density Lipoprotein, LDL, and the high density HDL. There's a lot more LDL than HDL in your blood, so the LDL level determines most of your total cholesterol, but higher levels of HDL are actually associated, in observational studies, with reduced risk for heart disease.

Randomized controlled trials of statin drugs, which lower LDL, have shown that they do indeed reduce the risk of atherosclerosis, and consequent heart disease and ischemic stroke, at least for people who have already had heart attacks or are at high risk. (Their value in people at average or even just above average risk is controversial.) So that adds to the evidence that high LDL causes the bad outcomes. (I must caution that it doesn't actually prove it. Statins could simultaneously lower LDL and do something else that reduces risk. But it adds to the plausibility of a direct causal association.) So naturally, drug companies have been working on pills that will raise HDL in hopes of making billions.

I have always been skeptical. (Yeah, that's easy for me to say now, but it's true.) HDL is higher in people who engage in lots of aerobic exercise, for one thing, and it's lower in people who smoke. Observational studies try to isolate its effect by controlling for consequences of exercise -- leanness and lower blood pressure, slower heart rate -- exercise itself, smoking, and all that good stuff. But that's really hard to do. HDL could just be a marker that goes along for the ride with the true protective factors.

So these researchers whose work is published in The Lancet used certain genotypes as what's called an "instrumental variable" -- some characteristic that people happen to have that effectively randomizes them in a sort of natural experiment. Some people have genes that predispose them to higher HDL. It turns out that having these genotypes is not protective against heart disease. As a check on the concept, having genes that predispose to higher LDL is indeed associated with higher risk.

This cautionary tale is important for several reasons, but the most important practical lesson is that we need to be much more cautious about approving drugs based on so-called "surrogate end points." We need to prove that they do what we really want them to do, which is to make us healthier or keep us healthier, or at least make us feel better. Changing some technical indicator that we think has something to do with being healthier isn't good enough.  

The Great Dying

That's a commonly used label for the Permian Extinction, 252 million years ago, in which 95% of living species went extinct. There is controversy over the underlying cause, but it does appear that marine life with carbonaceous skeletons -- molluscs and corals, mostly -- were wiped out due to higher ocean temperatures and more dissolved carbon dioxide, which made the water more acidic.

Oh yeah, the same thing is happening today, plus a lot of other huge changes that are causing another Great Dying. You've probably heard about this report from the World Wildlife Fund, which says that humans are consuming the earth's resources faster than they can be replaced. They don't even emphasize CO2 emissions, which seem to have triggered the Permian Extinction, but plenty of people are on that case, obviously.

The collapse of resources essential to human life will mean the collapse of the human population and, no doubt, catastrophic consequences for the social order. True, back in the '60s there were predictions that this would have happened by now, and it hasn't. A major reason is the so-called Green Revolution, which transformed agriculture with massive fossil fuel inputs. Don't be fooled by advertising or nostalgia: farming has nothing to do with nature and there is nothing less like nature than farm country. That just means that we bought time by doubling down on the mechanism that got us to the looming resource crises of that era: extracting the remains of ancient vegetation from beneath the earth and burning it for fuel.

That is what made it possible for the human population to expand from a few million to what will soon be more than 10 billion. It is the indispensable basis of our entire civilization and way of life, even for poor farmers and urban slum dwellers, although affluent people consume far more of fossil fuel and the abundance of products it makes possible.

We can't continue to live this way. It's over. But politics, in the U.S. and just about everywhere else, is not about the fundamental issues we face. Not at all. They are ignored. I don't care if you're liberal or conservative, Tea Party or Occupier, you are living in denial. What you are arguing about does matter, but it won't matter much longer if we keep on as we are. Wake up.

This is apparently supposed to be a secret in the U.S.

Eminence grise Arnold Relman, former editor of the New England Journal of Medicine, has published an essay in a British journal, that you aren't allowed to read if you aren't on a university faculty, about why the U.S. health care system is heading over the cliff and how to get it back on the highway. Great move Dr. Relman! That should have a big impact on the debate here in the United States, which I believe is why you might write such an essay.

We actually see a lot of this -- leading scientists taking to the pages of The Guardian to rebut climate change denial that appears in the Wall Street Journal  comes to mind. I suppose it's just not possible to get liberal arguments published in the United States.

Anyway, Relman basically makes three points: the concept of the "free market" does not work in health care; therefore we need universal, comprehensive, single payer national health care; and we need to reorganize the system into multi-specialty group practices with physicians paid salaries and some form of capitated payment.

It's the latter point which goes a step further than single payer advocates necessarily go. I've already become something of a broken record on the first two here but let me make a couple of quick summary points. Relman points to provider induced demand as the key failure of "the market" in health care but actually there are many others. These include the unpredictability of any given individual's need for health care -- unlike your need for food, clothing and shelter which is roughly similar for everyone; the very serious negative externalities when people don't get health care that they need, such as loss of economic productivity, transmission of infectious disease, and failure to care for dependents; and the erosive effects on society and culture of mass-scale abandonment of desperate people.

Relman also points to the inefficiency of private insurance and the massive waste it entails in the form of profits, marketing and administrative costs. But he does not see moving to a single payer system as sufficient in itself to solve our problems. Provider induced demand will continue to generate waste and even harm patients as long as doctors and hospitals are paid more to do more, and as long as drug and device manufacturers continue to bribe them, and manipulate both doctors and patients into wasteful spending. Salaried physicians in so-called Accountable Care Organizations are the solution for Relman. Maybe that is a good idea, but I should point out that they have done pretty well in Canada with fee-for-service primary care, while in the UK, physicians are paid salaries but they operate independent small practices for the most part.

Anyway, Relman notes that many physicians are already moving to multi-specialty group practices because there are advantages over being in business for yourself. These include reasonable hours, having administrative staff to worry about all that nonsense, more economic security, and having colleagues with varying expertise to collaborate with. He hopes that if this trend continues, it will become politically easier to make policy changes. But he also doesn't necessarily expect it. He thinks we'll likely have a catastrophic failure of the system, after which, eventually, after Grover Norquist and Paul Ryan are sent off on an ice floe, we might be able to fix things.

We shall see.

Terridiots

It's no surprise the corporate media loves the new undiebomber story. First, they don't have to do any work. Some official talks to them anonymously and they write down what he says. Is it necessarily exactly true, or the whole truth? Don't bother to ask, that's not your job. Plus which, it's a really cool spy story, and they get to be all worried about whether we are safe.

Well okay, let's assume it's all true. It strikes me that Al Qaeda in the Arabian Peninsula is seriously suffering from a lack of imagination. They are totally determined to somehow strike at the United States, but the only way to do this that meets their exacting standards for martyrdom is to have a guy blow himself up on an airplane. Since we know that's the only terrorist act they will ever attempt, we can make it fairly difficult. Hence the undiebombing technology. Scary!

However, not being a depraved terrorist, I can think of at least 16 ways to cause major carnage and disruption that are pretty much impossible to prevent, many of which do not even require that you have anything that is normally thought of as a weapon, let alone slaving away in your workshop for months to invent an undetectable suicide bomb. As a matter of fact, I could put a big fat plain old detectable bomb in my carry on luggage, wheel it up to the security checkpoint where there are 200 people in a tight mass, walk away and detonate it remotely, thereby shutting down every airport in the country until they figured out what to do to prevent me from doing it again, which they never could.

Without giving away my patentable idea, I could cause an economic catastrophe with maybe a dozen old dump trucks, or some chain saws. Do you have any idea how easy it is to derail a train? (I probably shouldn't have mentioned that.)  Anybody in the United States can buy a truckload of semi-automatic weapons, and well, use your imagination.

So, let's hope they stay obsessed with aviation. Or maybe, they are just a few wackos out in the desert and they don't have the people or the money to come to the U.S. and buy dump trucks. I vote for the latter.

Those improvident, irresponsible wastrels

That would be the half of Americans who aren't saving anything for retirement. Oh wait -- maybe it's because they can't. You need enough left over after paying for the rent and groceries and keeping your 1998 Honda Civic running to make the required minimum investment in an IRA.

So of course it makes perfect sense that the Republicans in congress want to cut food stamps, meals on wheels, child care and other programs to help poor people -- that would be working poor people, by the way -- in order to avoid cutting military spending.

Now why is military spending so important? Is it because the United States is under threat from powerful aggressors? Ha ha. It's because of that black goo deep in the earth. As Michael Klare makes clear, military tensions around the world are ramping up because it's harder and harder to get and everybody wants more and more of it. Why are there two U.S. aircraft carrier task forces in the Persian Gulf right now, along with a whole lot of guided missile cruisers and oh yeah, I bet you didn't know this, a U.S. Coast Guard station in Bahrain.

But if we keep on sucking that stuff out of the ground and burning it, as we are determined to do, nothing bad will happen except that we'll destroy civilization. It's a small price to pay.

Two Worlds

I don't usually link to the Puffington Host because it is infested with bunkum, but if you haven't already, do check out the first chapter of the latest book from The Shrill One, which happens to be available there.

Krugman describes the massive suffering and tragedy of the past few years, but as disturbing as the catastrophe itself is that he actually has to point it out. He is some sort of radical or alarmist because he bothers to notice the pain of so many people and the irrevocable losses we have suffered; and insists that we actually do something about it. The millions of young people who are graduating from college into a bleak future as far as the eye can see; the people in mid-life whose career accomplishments and savings are destroyed, along with their self-esteem; the countless people we don't even notice any more who are destitute; to the corporate media and much of political discourse, they are irrelevant. This is not the problem we need to worry about.

I have some thoughts about why this is. Do you?

Yes we are ruled by idiots

It's apparently too technical for the general public or Columbia-educated journalists to grasp, but if you follow Brad DeLong and/or The Shrill One you have probably gotten the idea that the elite consensus about the economy in Europe and the United States is completely insane.

I've been thinking about a simple, non-technical way to explain our situation that a smart politician such as, say, president Obama could use if he had the courage. The reason there aren't enough jobs is not because rich people have to pay taxes or companies are worried about "regulatory uncertainty." The reason is that companies can't sell enough stuff to expand output, and therefore to hire more people. The reason they can't sell more stuff is that there are too many people out of work or stuck in crappy jobs. That's why investors aren't putting their cash to work building up companies, they're sticking it in the equivalent of the mattress, i.e. U.S. treasury bonds that currently are providing a negative rate of interest, that is less than the rate of inflation -- which is also very low. So that cash is just sitting there.

The way to put people back to work, and therefore cause them to have money with which to buy stuff and therefore cause companies to sell more stuff and therefore hire more people, is to spend that money. You could actually spend it to pay people to dig holes and fill them in again, but even better to invest it in stuff that will also do good in the world, such as mass transit projects, fixing bridges, educating folks, modernizing the electrical grid, energy conservation and sustainable energy production, you name it.

The government has to do it this, using that money it can borrow extremely cheaply. That will also cause tax revenues to go up and make it possible to pay the debt in the future and reduce the deficit without having to do horrible damage to society.

This is the simple truth. Department of stupid questions: will we hear this simple truth discussed in the next six months?