You may have come across this rather appalling polling data from the Pew Research Center. It turns out that only 26% of U.S. adults know that 60 votes are required to end a filibuster in the Senate, and only 32% know that there were no Republican votes for the health care reform bill. Twenty-five percent think it takes only a simple majority, 51 votes, to end a filibuster. In other words, more than 2/3 of the people do not know that the reason the bill has not passed is because the Republicans have united to block it. They presumably think that the Democrats have simply failed to pass their own bill.
Does this mean that most people are idiots? No, it means that the corporate media are failing to clearly explain to them what is going on. Fox News -- according to another poll, the most trusted news source in America (really!) -- is deliberately deceiving them, and I suspect the other news networks have similar intentions but they're just a bit more subtle about it.
There are plenty of other important civic facts about which Americans are massively ignorant. This poses a very difficult problem of political philosophy. The republican form of government is supposed to insure accountability to the people, but obviously it does not if the people have no clue how government works or what their elected officials are actually doing.
I just heard our incoming Senator Scott Brown, apparently the most powerful and popular politician in America, telling an NPR reporter that he intends to insure that the health care bill doesn't pass because here in Massachusetts, we have a successful free market in health care that allows people to choose from many different private plans; and we don't need a government takeover of health care that forces people to buy government-run insurance. The reporter, of course, didn't bat an eye and didn't say a word. They just played the tape, presumably leaving listeners with the impression that Brown had just said something that was true and made sense. As I assume you know, if you read this blog, the senate bill essentially replicates the Massachusetts system, which Brown publicly supports and for which he voted as a state senator.
So we have the diagnosis - a corporate media that is varying combinations of corrupt, lazy, incompetent, and dishonest. However, I do not know what the treatment might be. For so long as this state of affairs persists, we are doomed.
Sunday, January 31, 2010
You may have come across this rather appalling polling data from the Pew Research Center. It turns out that only 26% of U.S. adults know that 60 votes are required to end a filibuster in the Senate, and only 32% know that there were no Republican votes for the health care reform bill. Twenty-five percent think it takes only a simple majority, 51 votes, to end a filibuster. In other words, more than 2/3 of the people do not know that the reason the bill has not passed is because the Republicans have united to block it. They presumably think that the Democrats have simply failed to pass their own bill.
Friday, January 29, 2010
So, whatever combination of politics and wisdom has produced the available set of Funding Opportunity Announcements from NIH and now I want funding for my research. It's possible, of course, that what I want to study just doesn't fit any of those announcements very well; it's also possible that I don't care what I study, I just want money, so I tailor something to fit an FOA. Fortunately for me, I really, truly, honest to gosh am interested in questions that I can at least make a credible argument do pertain to a specific program announcement. However, there's a wrinkle.
NIH has recently done a major revamp of its proposal specifications and review criteria. The basic process is still the same, so let me first explain that.
As proposals come in -- we used to have to mail cubes of paper, but it's now entirely electronic -- they get assigned to a review committee. Most of these belong to an entity called the Center for Scientific Review, but some belong to individual institutes and centers (I/Cs). CSR has a lot of standing committees, but there are also what are called Special Emphasis Panels, that may meet only once to review applications in response to an RFA and are more likely to pertain to an I/C. It's complicated.
The members of these panels are scientists who specialize in the relevant field, generally people who have received NIH funding and generally fairly senior people, i.e. they at least have the title of Associate Professor. Academia is very hierarchical and is infected with a certain amount of snobbery. You can ask to have your proposal steered to a specific panel, and you can also ask certain reviewers to be disqualified if you think they have it in for you, but there's no guarantee you'll get your wish.
The review committee rosters are posted publicly about 30 days before the meeting, but it is absolutely verboten to contact any of them in any way to try to lobby for your proposal. The staff assigns your proposal to three of them (occasionally only two), who are the only members of the committee who will actually read it. These three will give the proposal a preliminary score (which I'll explain later) before the meeting. Proposals in the bottom half at this point won't even be discussed in the meeting, they just get summarily trashed. You will get the comments from your three reviewers but that's all. This isn't necessarily fair because the reviewers haven't seen the rest of the proposals so they don't know if you're really in the bottom half or not but that's the way it goes.
For the proposals that make the first cut, the three readers will take turns presenting and discussing them. The rest of the committee members are sitting around a big table with their laptops and as the reviewers are yacking, they're pulling up your proposal from a CD and trying to skim the abstract and whatever else they feel like looking at to get a sense of what's going on. If any of them happen to have a conflict of interest, such as working with you on a funded collaboration or your having an affair with their wife, they're supposed to leave the room and not take part, but this is pretty much on the honor system. No, it's not blind -- they know who you are and they even have your life story. Then there's some general discussion and all of the committee members give your proposal a score, even though 90% of them haven't actually read it.
After the staff has time to process the whole enterprise, you will get access to your score and the comments from the three readers. You'll also get a percentile ranking that tells you where you stand in relation to other proposals and gives you an idea of whether you're likely to be funded. But the actual funding decision is made by the relevant national advisory council a couple of months later. They don't have to fund the top-scoring proposals: staff can weigh in with their own recommendations and the ICs established priorities and other factors can override the rankings from the review committees. The priority score is very influential, but it's no guarantee either way.
So next time, I'll discuss the proposal review criteria and what it all means, which is more philosophically interesting.
Thursday, January 28, 2010
before I get to the NIH proposal. In my recent series on Health Care Policy 101 I expended quite a few bytes explaining why making people pay more of the cost of health care out of pocket does not result in containing health care costs, or wiser allocation, or consumer sovereignty, or any of that free market conservative libertarian jive.
So here it is, actual data, the real world, truth -- as opposed to ideology. Amal Travadi and colleagues report on an experiment: almost 900,000 Medicare beneficiaries constitute the study population. Some were enrolled in plans that increased copays for outpatient care -- on average they nearly doubled, from $7.38 for a primary care visit to $14.38; and from $12.66 to $22.05 for
primary specialty care visits. Others were enrolled in plans that did not change co-pays. And yes, the people whose co-pays were increased did indeed reduce their use of outpatient services. But something else also happened:
In the year after the rise in copayments, plans that increased cost sharing had 19.8 fewer annual outpatient visits per 100 enrollees (95% confidence interval [CI], 16.6 to 23.1), 2.2 additional annual hospital admissions per 100 enrollees (95% CI, 1.8 to 2.6), 13.4 more annual inpatient days per 100 enrollees (95% CI, 10.2 to 16.6), and an increase of 0.7 percentage points in the proportion of enrollees who were hospitalized (95% CI, 0.51 to 0.95), as compared with concurrent trends in control plans. These estimates were consistent among a cohort of continuously enrolled beneficiaries. The effects of increases in copayments for ambulatory care were magnified among enrollees living in areas of lower income and education and among enrollees who had hypertension, diabetes, or a history of myocardial infarction.
Conclusions Raising cost sharing for ambulatory care among elderly patients may have adverse health consequences and may increase total spending on health care.
Get it? It's just like I said: increasing out of pocket costs does cause people to use less of the relatively inexpensive primary and wellness care services, but then they end up really sick and it costs more in the end. D'oh.
I have to interrupt this series to say something about Howard, who died suddenly yesterday while he was traveling in California. I had the privilege of meeting him a few times back in my days as a Cambridge hippie-pinko-peacenik, when he spoke at various events I was involved in organizing. We'd charge for tickets and pack the people in, and then we'd have enough money to continue with our subversive activities for a few more months.
Howard wasn't the most dynamic speaker. His approach was low key and conversational. He seemed perplexed that people would actually single him out and ask him to stand in front of a room and deliver a monologue, as though there was something special about him. You'd listen because you were interested in what he had to say, not because he was an entertainer. He was the humblest, most regular famous person you'd ever meet.
Anyway, Howard was most famous for his book A People's History of the United States, and it was indeed an extraordinary accomplishment. In fact, I would go so far as to say it was one of the most influential books of the 20th Century, not because of its impact on high powered intellectuals or the people with their hands on the levers of power, of which as far as I know it had none; but because of the way it changed generations of college students. I don't know how many people's view of not just U.S. history, but the world, was fundamentally changed by Howard's book, but you meet them all the time. It might well be millions who he showed how to see through the myths that are conventionally taught as history, and to understand history as it was really experienced, from the ground up, by ordinary people. That's who he was talking to, and that's who he reached.
So farewell Howard, you go out a winner.
Wednesday, January 27, 2010
to the tender hands of the National Institutes of Health.
So here's how it works. Congress broadly allocates money to the Institutes and Centers, perhaps with some additional guidance as to priorities and processes. It's considered unseemly for Congress to specifically earmark NIH funding or get into micromanaging it too much, but it does occasionally happen. Fortunately that's a minor issue so far but it is a legitimate complaint that the diseases with better organized and more effective constituencies get disproportionate funding. Since much of my work concerns HIV, and that's one of the winners, I suppose I shouldn't complain.
The Director organizes broad strategic planning. The Institutes and Centers all have national advisory boards consisting of both scientists and lay representatives of interested constituencies, and of course they have professional staff. The advisory boards are influential and the general public can comment on their activities but you'll have to decide for yourself how democratic the process of allocating funding really is since only highly committed and engaged people take the initiative to participate. In any event, the result of interaction between the bureaucracy and the public representatives is the issuance of various kinds of solicitations for proposals.
These are categorized according to multiple dimensions. Program Announcements are ongoing solicitations that can remain open for years and generally have quarterly submission deadlines. They define a broad area of interest. The one I just applied to is called Understanding and Promoting Health Literacy, and multiple institutes and centers participate. When you apply, you tell them which one you think will be the best fit to consider your proposal. Some Program Announcements are more narrowly focused and pertain to one or a few I/Cs. In any event these are considered "investigator initiated" research and you get to define the research questions and the study design within the general area of interest.
Requests for Applications are one-time solicitations for investigators to do more narrowly defined research that the I/C is interested in.
Then there are various "funding mechanisms": R01s are large scale investigator-initiated studies based on fully developed preliminary work intended to get definitive answers to questions. Clinical trials are a typical example, but they can also include laboratory research or large-scale epidemiological studies. R-21s are "Exploratory/Developmental" projects intended to prepare for an R01. That's my proposal. There are also R-34s which are kind of like R-21s but for training interventions; research program and research center grants which support building major institutional components around an entire area of research; and various kinds of training and career development awards, infrastructure awards, and odds and ends. These all have their own budgetary limits and other restrictions.
If you want to try for NIH funding, you have to understand all of this jargon and the ins and outs of what they are looking for. If any readers are truly interested -- and I'm not saying you ought to be -- the basic 4-1-1 is here.
Next I'll get to the peer review process and funding criteria, and hopefully the discussion will actually get interesting. But remember, once again -- this is your money, and it's being spent, in theory, to solve problems that might really matter to you. So wonky as all this may be, you might want to know about it.
Tuesday, January 26, 2010
for not posting yesterday -- an NIH proposal deadline. There is an ineluctable law of nature, that no proposal is ever finished before the deadline. I thought I had violated it by three hours, but then a glitch happened and the actual time stamp on my submission turned out to be 16:50, which is ten minutes before the deadline.
Anyhow, this seems a good occasion to give a quick tour of the National Institutes of Health extramural research funding process. It's your money, after all. Federal funding for health-related research is pretty popular, but there is something of a perverse influence in that it is built largely around constituencies for specific diseases. People advocate for cancer, HIV, diabetes, heart disease, MS, etc., and to a considerable extent the allocation of funds is influenced by the strength of the various disease lobbies. NIH is divided into numerous institutes and centers. Some are defined by organ systems or categories of disease. Examples are the National Cancer Institute, National Heart, Lung and Blood Institute, National Institute on Drug Abuse, etc. (Alcoholism has a separate institute, which makes absolutely no sense scientifically but does reflect deeply rooted cultural biases.) Note that some of these have narrower definitions than others; some of them are sort of a grab bag, such as the National Institute of Diabetes and Digestive and Kidney Diseases. Then there are life-cycle institutes -- National Institute on Aging, National Institute of Child Health and Human Development; and more etiologically or contextually defined institutes -- National Institute of Environmental health Sciences, National Center for Minority Health and Health Disparities; and finally the discipline-focused institutes such as the National Center for Nursing Research and the much-maligned National Center for Complementary and Alternative Medicine. The National Institute of General Medical Sciences supports basic research that doesn't need a specific disease or other kind of focus.
So you'll see right away that the organization of NIH reflects multiple theoretical orientations toward health and illness, and multiple political dimensions of interest. The process for allocating funds to particular areas of research starts with some political guidance from Congress but the process of awarding funds to specific investigators for specific studies is purportedly designed to be insulated from politics and based on science. Next time, I'll give you my own take on that. (I'll also tell you something about my own proposal.)
Sunday, January 24, 2010
While the view that our political culture places less value on equity justice than that of other nations is widely shared, it is largely a qualitative argument rather than a hard fact. However, survey research and hard statistics clearly show another difference between the U.S. and the other wealthy countries: we are by far the most religious. I draw on James A. Haught, "Fading Faith" in the new Free Inquiry for the following facts.
A recent poll finds that only 15% of Europeans go to church. On an average Sunday, fewer than 5% of Danes or Swedes are in church. Irish churches are mostly vacant. In 1900, more than half of British children attended Sunday School. Today, the figure is 4%. In Canada, only 20% of adults attend church regularly and in 20001 43% reported they had not been in a church for the past 12 months. 45% of Australians were regular worshipers in 1950, but only 20% in 2000. And so on. Large majorities of people in these countries accept the theory of evolution and are essentially secular in their outlook, though they may identify with one or another religion as a heritage or ethnic label.
In the U.S., however, 90% of those polled say they believe in God, heaven, hell angels and so on. 80% of Americans say they believe Jesus was born of a virgin and half think he will return to earth. 45% of Americans reject the theory of evolution (compared with 7% of Britons and even fewer elsewhere in Europe), and half of the rest believe it happened with divine guidance. Americans donate $100 billion per year to their churches. While mainline protestant denominations are rapidly shrinking, people are flocking to evangelical and pentecostal churches in growing numbers.
As we all know, these growing fundamentalist congregations are the bedrock of Republican and conservative politics in the U.S. They donate money, turn out and volunteer, and above all turn out and vote for politicians who promise to do the work of Jesus, which includes eliminating environmental regulations, social welfare programs, and taxes on wealthy people; a bullying foreign policy backed up by military aggression; consigning perceived enemies to secret dungeons for torture; proclaiming zygotes to be human babies (just like it says in the Bible); and establishing Christian theocratic dominion over the nation and the world.
In this version of Christianity, the only form of justice is punishment and ostracism of people whose sexual behavior does not conform to Christian standards, second class citizenship for those who fail to worship the correct deity in the correct manner, and vengeance against any group of people who challenge Christian supremacy.
The good news is that there is a countervailing movement away from religion in the U.S. More Americans than ever before -- about 20% now -- say they are not religious. I would say that our only hope is for that number to grow to something like 100%.
Friday, January 22, 2010
Contrasting the U.S. with the U.K. Constance A. Nathanson writes in the new Lancet:
Reduction of health inequalities is certainly not a goal of federal policy in the USA, even in these days of health-care reform. We have an extraordinary record of government support for the documentation of health “disparities” (the currently preferred term), and although health disparities have become a highly fundable research topic, even this fairly anodyne research arena is largely divorced from serious policy making. In the absence of a universal system of medical care with the declared goal of mitigating inequalities, health disparities, inequalities, and inequities have by default become the province of public health, perhaps accounting for our plethora of public health institutions relative to other Western countries: in the USA public health departments play a major role as caregivers for the poor. Many Americans are perfectly content with a two-tiered system that renders not only health inequalities but also the costs of the system that perpetuates those inequalities largely invisible.
Actually the elimination of health disparities has been an official national goal since the Clinton Administration. Unfortunately, the target date was 2010 and, err, we didn't make it. Actually we didn't even make any real progress, although we did invest in data tracking systems and, as Nathanson says, it's been a fundable research topic. We certainly know more about it than we did before. By "we," however, I mean those of us who get the grants to study the issue and go to conferences where we talk to each other about it. And, of course, the 6 1/2 readers of this blog.
The fact is that justice is simply not a value that is important to Americans, at least not in comparison with most people the world over. This cultural fact translates into a social fact: we have more inequality than other wealthy countries, and we are getting more and more unequal. The Supreme Court's ruling yesterday that corporations have the rights of humans -- actually even more than the rights of humans -- to spend unlimited resources on influencing elections through paid advertising and whatever other means they desire (they can already buy cable news channels) will just accelerate the process. As U.S. society grows more and more predatory and the people continue to be bamboozled into voting against their own interests, it will be interesting to see where the limit may be to this process. One would suppose there must be one, but how will it end?
This has occurred in the past, of course, and has been interrupted by crises in which a segment of the capitalist class elected to save the system by reforming it. One such hero is on the dimes in your pocket. Will they be so wise next time?
The indescribably grim news coming out of Haiti should at least help Americans to put their own problems in perspective, but it probably won't.
Really folks, a small group of religious fanatics somewhere in remote mountains with no indoor plumbing, who every once in a while persuade some mixed up young man to make a lame attempt to blow himself up on an airliner, are not an "existential," "transcendental," or even particularly important threat to the United States or to you and your loved ones in particular. They do not constitute a reason to repeal the Bill of Rights and repudiate the Geneva Conventions. I heard a young woman quoted on NPR saying she voted for Scott Brown because she was outraged by the prospect of trying terrorists in civilian courts. Really -- for her, the fear that someone accused of attempting a terrorist attack might get a trial and have to be convicted based on evidence and the rule of law trumps everything else that government might do, for better or for worse.
The British endured a campaign of terrorism by the Irish Republican Army for 30 years. More recently, of course, they have endured one horrifically successful attack on London mass transit and additional failed attempts. British politicians never labeled these campaigns -- which were much more effective than anything we have experienced since September 2001 -- as "existential" threats, never advocated torturing prisoners (although abuses did take place, they were ultimately acknowledged and were never officially authorized), did not suspend civil liberties, and dealt with the problem through law enforcement and the judiciary. Britain is still around, and the IRA has been defeated.
We should be far more terrorized by ordinary crime, domestic violence, motor vehicle crashes, house fires, floods -- events which happen continually and kill tens of thousands of Americans every year, many due to human intention. Our problem with La Cosa Nostra didn't lead us to bomb Sicily or ship Italian-Americans off to secret dungeons for indefinite confinement without legal recourse. Today we are afflicted by Colombian and Mexican drug gangs, rural methamphetamine labs, sex slavery -- all sorts of truly dangerous, egregious, and harmful activities going on within our borders that far exceed in their actually existing and continual harm anything al Qaeda can even contemplate.
So why do we have this irrational panic? In part, of course, it's because politicians, mostly Republicans, demagogue about this issue. In part it's because the government has set up the illusion that we are at war and lots of people just have a gut instinct that if we're at war, we need to do whatever it takes to "win," and they interpret that very crudely. If there is a war, of course, it's a war of ideas and values, and what we are doing is precisely what the enemy wants us to do and constitutes nothing but reflexive, cowardly surrender.
The smart thing would be for some political leaders -- say, the president? -- to stand up and say exactly that. But they're all too chickenshit.
Thursday, January 21, 2010
You may have heard about this calculation -- not really a study, that figures "Reducing dietary salt by 3 g per day is projected to reduce the annual number of new cases of [heart disease] by 60,000 to 120,000, stroke by 32,000 to 66,000, and myocardial infarction by 54,000 to 99,000 and to reduce the annual number of deaths from any cause by 44,000 to 92,000."
This would not be a huge difference to you personally -- while they come up with a wide range of estimates for various effects, the average is around 4 fewer deaths per year per 10,000 people. It's more important to buckle your seat belt. On the other hand, it's a much bigger impact than preventing guys from blowing up their underwear on airplanes. The point is, when you have a small effect over the entire population, it adds up, and many of these measures cost little or nothing. Reducing average salt intake by 3 grams a day doesn't really cost anything, since this could be achieved by reducing the amount of salt in processed foods, including bread. It has a benefit similar to treating people at moderate risk with statins, but that's expensive. In fact, the authors claim it would have the same effect on coronary heart disease rates as a 50% reduction in smoking. Smoking creates much higher individual risk, but most people don't smoke. (Of course smoking also causes cancer and other diseases, not to mention house fires, so the total benefit of reducing smoking prevalence is greater.)
There are many examples of interventions like this that cost little and have a big impact because they affect lots of people. Workplace smoking bans are another excellent example, as is removing trans-fats from the food supply. Eliminating agricultural subsidies -- which make meat and corn syrup artificially cheap -- would be another. (Not going to war is a good one too, although that's in a category by itself.) The reason we don't do all these simple things is mostly because of the political power of concentrated corporate interests, and the idiotic yammerings of libertarians who insist on their God-given right to be poisoned even though they aren't actually choosing it in the first place.
These aren't the most dramatic issues confronting us but they illustrate the distorted priorities in the political culture and the political establishment that it spawns.
I'm feeling that it's pointless to study, think and write about public policy because our dysfunctional political system can't make good policy happen. Maybe I should just scream invective and paint Hitler mustaches on pictures of corporate executives.
Why did I go to graduate school anyway?
Wednesday, January 20, 2010
I don't normally talk much about politics here -- as opposed to policy -- because it's not my particular expertise, and there are lots of other blogs you can go to if you want to obsess about the subject. But I do feel compelled to comment on the special election yesterday as a citizen of Massachusetts. (Don't blame me, I'm from Jamaica Plain.)
The victory of Scott Brown seems just about bizarre, in a state that is known as the most liberal in the nation, over Ted Kennedy's Senate seat, at a time when everybody knows that the consequence of electing Brown is the total obstruction of Democratic initiatives for the foreseeable future and a completely dysfunctional congress. Is that really what Massachusetts voters wanted? Of course there is that clueless contingent who are quoted as voting for Brown because they don't want civilian trials for terrorists and similar nonsense, but they have always been here. That isn't what swung the election.
The problem, as I see it, is that the Democratic Party in Massachusetts has become a self-serving, inward looking, incestuous institution that is almost entirely disconnected from its base of voters and doesn't seem to exist for any reason but to provide its politicians with jobs, to which they believe they are simply entitled. Martha Coakley was a perfect exemplar. Her first act upon winning the primary was to go on vacation for two weeks. Then she did not deign to actually campaign, radiated entitlement, and repeatedly expressed contempt for the voters and the ordinary rituals of campaigning.
She isn't one of the cronies of the party establishment in Boston, so they didn't go to work for her. The Mayor never even endorsed her, as far as I know. Why should they care if she wins or loses? She isn't one of them.
Finally, Coakley and the Democrats didn't give people a reason to vote for her. People are scared right now, about their jobs if they're lucky enough to have one, and about ending up sleeping in their car if they aren't that lucky. The threat from Islamic terrorists is not truly serious, but it creates an inchoate dread that is easy raw material for demagogues. Yet the Democrats seem to be giving away their money to Wall Street plutocrats, they aren't getting jobs, and they aren't hearing the sort of rhetoric, empty though it may be, that will reassure them about their safety. (The Dems don't actually have to do anything differently. It's all about style here.) Worst of all, they have spent the past six months playing Capitol Hill inside baseball with health care reform without bothering to explain what they are trying to do and why it is important; while they seem to be ignoring the real and immediate pain that many people are feeling.
Why this party cannot get its act together I do not know, but they can't. It shouldn't be that difficult, all their friends are yelling at them, telling them exactly what they need to do, but they're just raising money from bankers to pay their worthless consultants. Without a viable people's party, our political system is irredeemable. But that's where we are.
Tuesday, January 19, 2010
The European medical community was always a bit less amped up about the H1N1 "pandemic" than their counterparts here, and they have been much more reflective about the mass hysteria now that it has passed. There are three items in today's BMJ that, unfortunately, are hidden behind the subscription wall. I will summarize.
First, Deputy Editor Tony Delamothe, in the regular Editor's Choice column, writes:
If influenza was a rock band how would it rate its latest release, H1N1? Not too well, I suspect, despite the greatest prepublicity since—well, its previous release. And it all started so promisingly, in Mexico, whose population had been decimated by the very first outbreak of Spanish flu (and smallpox and measles), courtesy of Cortés and his conquistadores.
. . . Once the international tour began, all eyes were on the southern hemisphere for pointers as to how things might play out in the northern hemisphere winter. So what happened next?
For England, many more misses than hits. Since last August, the consultation rates for flu-like illness have hardly budged above the baseline threshold. They’re now less than half that rate and falling. Even the most generous assessment couldn’t attribute this happy state of affairs to either the use of oseltamivir (Tamiflu) or vaccination against swine flu. Both interventions are now uncomfortably under the spotlight.
Very uncomfortably, as it turns out. As has barely been reported in the U.S., Wolfgang Wodard, the Chair of the health sub-committee of the parliamentary assembly of the Council of Europe has called for an investigation into whether drug companies unduly influenced the WHO and generally ginned up the hype. According to his resolution:
To promote their patented drugs and vaccines against flu, pharmaceutical companies have influenced scientists and official agencies, responsible for public health standards, to alarm governments. . . . They have made them squander tight healthcare resources for inefficient vaccine strategies and needlessly exposed millions of people to the risk of unknown side effects of insufficiently tested vaccines.
And indeed, the conspiracy theory gets a boost because it turns out that Juhani Eskola, a vaccines advisor on the WHO board has recently received $9 million for his research center from GlaxoSmithKline, manufacturer of the H1N1 vaccine Pandemrix, which European governments paid millions to stockpile and are now trying to somehow get rid of.
Meanwhile Catherine F Houlihan and colleagues write:
Over six weeks (1 July 2009 to 15 August 2009) we reviewed cases of potentially life threatening conditions admitted to the Newcastle infection services in which diagnosis and management were delayed because of an initial, incorrect diagnosis of swine flu. . . .
A label of swine flu resulted in an average diagnostic delay of three days in six adults and two children who were admitted with potentially life threatening infection requiring timely antimicrobials. They had instead meningococcal meningitis; severe (11% parasitaemia) and mild (0.2%) Plasmodium falciparum malaria complicated by renal failure; acute myeloblastic leukaemia presenting with febrile pancytopenia; Campylobacter gastroenteritis with renal failure; Haemophilus influenzae respiratory tract infection (bone marrow transplant recipient); complicated soft tissue infection; and a fatal Staphylococcus aureus bacteraemia with multiorgan failure.
Now, personally, I don't necessarily think that Mr. Wodarg is right to be concerned about the safety of the H1N1 vaccine, nor was it necessarily wrong for governments to stockpile as much vaccine as they did. Ending up with too much is better than finding yourself with too little.
The point that sticks with me is the cost of over-hyping and over-obsessing about this matter. It was never certain or even likely that it was going to develop into a major public health emergency, or have catastrophic consequences, but the authorities, internationally and in the U.S.; the news media; and even, unfortunately, some prominent voices among progressives who should have known better, screamed about it for months on end as if the end of civilization were at hand. Furthermore, even the worst case scenario was not sufficient to justify the relentless, exclusive focus on flu and systematically ignore the many very real and much more serious public health crises that already plague humanity and do so continually. A flu pandemic is over with in a year or so; the ongoing scourges of humanity, from HIV to malaria to contaminated water to malnutrition to poverty to child abuse to drug addiction, and on and on and on, keep on happening.
They deserve far more attention, and they got none because of this misguided hysteria.
Now that the manufactured crisis has passed over and we are left with a tragedy for a few hundred families and what has otherwise been a milder than normal flu season, the price we pay for this is, of course, the Chicken Little phenomenon. However sincere the alarmists may have been, whether their motives were pure or not, they are perceived as at best overinvolved in their own areas of self-interest and at worst corrupt. And the next time they try to sound an alarm, even if there is more basis for it, they will not be believed.
That is what I have been predicting all along. Just sayin'.
Monday, January 18, 2010
My life coincides with the modern Civil Rights Movement. I was born the day after Brown v Board of Education was decided. (Now you've learned my secret.) Martin Luther King Jr. emerged on the national stage just a year later, in the Montgomery bus boycott, and as I became aware of the world in my elementary school years the movement was at its height with the sit ins, the freedom rides, and the voting rights struggles. Dr. King was murdered when I was 14. After I graduated from college, I became an ACORN organizer. I don't suppose many people know the true history of ACORN or what it's all about but the idea was sparked by George Wiley and people associated with the Congress of Racial Equality.
Dr. King's political legacy has been sanitized. A national holiday that truly celebrated his beliefs could only exist in a different country from this one. In his brief career he moved beyond leadership of an ethnic liberation movement to a fundamental critique of U.S. society in which racism was only one component. He tried to transform the Black liberation movement he inspired into a poor people's movement. He condemned the U.S. war in Vietnam as just one manifestation of an imperialist ideology intimately tied to the exploitation of American workers. The entire time, the FBI was trying to kill him. This is a documented, historic fact, not a wacko conspiracy theory. J. Edgar Hoover personally wrote to him and offered not to reveal evidence of his adultery if he would kill himself, for one example. And J. Edgar Hoover's name is still on the FBI building in Washington.
Sen. Kerry is trying to force the FBI to open up its records of the era. Yes, it's true: the conduct of your government in domestic matters 50 years ago is still a secret from you, the citizens of the U.S. As the Globe's Bryan Bender reports:
[Stuart] Wexler, 33, was recently researching a book about plots to murder King when he learned the FBI’s archives contained a document about a Ku Klux Klan leader who claimed to have played a role in the civil rights leader’s assassination in 1968. When Wexler filed a request for a copy, he was informed that it had been destroyed as part of regular house cleaning. He then learned there had been a government clerical error and the file was not lost to history.
Still, Wexler will have to submit another formal request, this time with the right file number, and is unsure what he will receive, or when he will receive it.
Others also believe the FBI is holding on to a variety of records that may contain valuable information, including leads the FBI may not have followed about a rash of racial killings in the South from the 1940s to the 1960s.
No shit Sherlock. The FBI in fact committed many of those killings - that is to say, the perpetrators were on the FBI payroll.
Sadly, today, Dr. King's dream of creating a movement for human liberation that transcended ethnic and racial divisions has failed. Struggling white people in the U.S. are being seduced by a far right, racist movement that has them convinced their problems come from efforts by government to promote equality, which they interpret as taking from good people like themselves and giving to those dark others. That has been the fundamental problem in American politics since the failure of the Populist Movement of the late 19th Century, a failure rooted in precisely the same problems we face today: Racial divisions in the working class, and a Democratic Party ultimately controlled by financial interests that consistently betrays its popular base.
Oh well. I'll never give up.
Sunday, January 17, 2010
Sorry I've been away, I've had to deal with a (very) minor personal disaster of my own. The only costs are material and psychic -- unpleasant, but it's just stuff.
Meanwhile, of course, none of us has any right to self-pity at this moment. I do wish to point out, however, that the earthquake in Haiti, like the earthquake in Kashmir in 2005, was not a natural disaster. It was largely caused by humans. Haiti and Kashmir both suffered so terribly from earthquakes because of the prevalent unframed masonry construction. The reason both countries relied on unframed masonry construction is that they had long ago cut down all their trees, and were too poor to import timber. Deforestation in these cases resulted not from multinational logging operations as is happening in tropical rain forests, but from a burgeoning human population that consumed wood for fuel and cleared forests because of land hunger. Deforestation also contributed to the casualty toll because it created unstable ground, causing buildings to avalanche.
Getting to a sustainable human civilization is going to be very difficult because fossil fuels are currently the main substitute for biomass. The European settlers cut down the New England forest, not so much for farm and pasture, but for charcoal. Since the advent of the fossil fuel era, the New England forest has grown back. Haiti cannot be reforested unless the people can afford to leave the wood alone. It's a very tough challenge.
Thursday, January 14, 2010
Just in time for our needs here at Stayin' Alive, Katherine Baicker and Amitabh Chandra in the new NEJM (subscription only, alas) lay out exactly how cost effectiveness analysis intersects with the problem of universal coverage. Beginning with the premise that resources are finite, and that spending more to give more people more expensive health insurance means we have to spend less on other things, they show some clear tradeoffs.
Suppose we had $180 billion a year to spend on expanding health insurance. (That may seem like a lot but it's a heck of a lot less than we're spending on wars right now.) Right now premiums for employer-provided individual health insurance in the U.S. cover a wide range. The median is $4,200 a year, $3,500 is the 25th percentile, and $5,100 the 75th. With a $6,000 policy, you could cover 30 million people; with a $3,500 policy, more than 50 million people could be covered. In other words, you don't get universal coverage, or you do.
So, what do we give up by opting for less expensive benefits? If we concentrate on providing care that gives more benefit for the dollar, not much. Maybe nothing. You might be surprised by some of the following cost-effectiveness comparisons.
Giving people with HIV anti-retroviral therapy costs less than $100,000 per QALY gained. (Actually I would imagine quite a lot less although they don't say exactly how much.) On the other hand, giving a generic statin to women under 45 who don't smoke -- a much cheaper drug, just a few dollars a month -- costs more than $500,000 per QALY. It might surprise you that liver transplants for people with an autoimmune disease of the bile ducts is also quite cost effective; whereas coronary artery bypass grafts, which are very commonly performed, aren't so great.
So there's just no way around it. If you want to keep health care costs finite, and thereby cover more people -- presumably everybody -- you can't pay for every damn thing. You need to ration. Not on the basis of what you think the worth is of any individual, but on the basis of the benefit you get for the money. That is the fundamental misconception driving the absurd public debate about this issue.
In fact, if you think about it, people with HIV are often stigmatized. A disproportionate number of them have addiction histories, have spent time in jail, and have other chronic diseases including mental illness and therefore are disabled. Yet cost effectiveness analysis says we should treat them before we start to think about CABG for middle-aged executives. We're saying that everybody's life and health is equally valuable; we're trying to get the most for everybody.
Both justice and liberty demand it. There is no tradeoff, no contradiction, on that basis. Now, is there a politician in this country who has the courage to get up and say that?
Wednesday, January 13, 2010
Actually that wasn't the title I originally intended for this post, but it so happens I was going to talk about a general issue and along came the earthquake in Haiti to serve as a very tragic particular example. So let me begin with the post I had in mind.
For reasons not entirely clear even to me, I have long been fascinated by the so-called Tunguska event. As most readers probably know, at least in general terms, a little more than 100 years ago, on June 30, 1908, an object exploded about 5 miles above a remote location in Siberia. The force of the explosion has been estimated to be equivalent to 185 Hiroshima bombs. Most scientists believe the object was an asteroid, estimated to weigh 220 million pounds, heated to more than 44,000 degrees Fahrenheit by friction with the atmosphere. However, as the object was destroyed in the explosion and no fragment of it has been found, there are those who hold to the theory that it was a comet.
NASA estimates that comparable events happen on average about once every 300 years. So while nothing like it will probably happen in my lifetime, you never know. If it does, most likely the impact will be above the ocean, or another sparsely populated location -- the boreal forest again, the tundra, polar region, or desert. However, if it did occur over a populous region, the catastrophe would be unimaginable. The Tunguska explosion completely stripped trees of their branches and bark at ground zero, and knocked every tree to the ground farther away for a distance of 70 kilometers. (The blast was directed straight down at ground zero and horizontally further away.)
The philosophical importance of this is simply that there are disasters that we cannot prepare for, cannot plan for, cannot ameliorate, and which strike without any pattern or predictability. For all the effort we might put into health promotion and disease prevention, sometimes stuff just happens. Of course there are shades and borderline areas. San Francisco is prepared for earthquakes with strict building codes and emergency services at the ready, but Haiti is far too impoverished to prepare meaningfully, especially since a strong earthquake in that location was not expected. As you know, I thought the H1N1 influenza thing has been greatly overhyped and over discussed -- and that is something for which preparation and amelioration were possible, obviously -- but for all the nattering about preparedness, a globally catastrophic outbreak of a novel infectious disease, which we can do little or nothing about, is indeed possible.
At this point, anthropogenic global warming cannot be stopped, although it can be slowed down. But even though the warming itself is preventable in principle, climate is not yet fully predictable -- much less the weather -- and we cannot anticipate all of the consequences that may occur. Some people, I think, exaggerate the appropriate level of alarm. It will not destroy civilization or exterminate humanity. However, it may well mean there cannot be nearly as many of us as there are now, and that we'll have to get there the hard way.
None of this is pleasant to contemplate, I know, but it's reality. Whether humanity will ever fully master the threats posed by our indifferent universe is questionable. But we should live our lives with consciousness of the privilege they represent.
Update: It turns out the possibility of a major earthquake near Port au Prince was known, but essentially, there was nothing Haiti could do about it. I have known quite a few Haitians professionally in my career, and I have learned a lot about the country. As the story develops, this appears to be a catastrophe rivaling the Asian Tsunami. This Kos diarists tells you how you can help.
Tuesday, January 12, 2010
Before I get to my boffo conclusion, I do want to take a moment to focus on the problem of liberty in the context of health care reform. It seems to me untenable for people who claim to put individual liberty before other values to condemn efforts to rationally allocate medical interventions. Remember that the idea is not to forbid anyone from going out and spending whatever of their own money they happen to have on whatever foolishness they may wish to waste it on; rather it is to restrict their claim on other people's money, whether as part of a private or a public insurance pool.
If you happen to be wealthy and you can find a surgeon to do a vertebroplasty on you, go for it. But why do libertarians insist that I should be required to help pay for it if all the evidence shows that it doesn't do any good? Perhaps even more bizarre is the right wing freak out over end of life care. How does it crush my liberty for Medicare to offer to pay for counseling so that I can make my own, informed decisions about how I want to check out when the time comes? And think back to Terry Schiavo -- remember that it was the taxpayers of Florida and the United States who were paying to keep her corpse breathing, despite the wishes of her next of kin.
As for universality, it is evident to me that it does not compromise liberty, but enhances it. True, it requires the younger and more fortunate to subsidize, to some extent, the older and the less fortunate. But remember that we are all going to trade positions at some point. And when the young and fortunate become older and/or less fortunate, they are going to assert a claim on the rest of us regardless of whether they paid their share previously. That diminishes the liberty of the rest of us by taking from us unfairly; at the same time, when people suffer pain and disability that could be avoided or ameliorated, obviously their liberty is reduced.
Universal, progressively financed health care hits the sweet spot in political philosophy because it simultaneously enhances both justice and liberty. The contradiction that libertarians are determined to see between these principles just isn't there. You get two for the price of one.
Which brings me to the contemporary grassroots conservative movement known as the Teabaggers. It is difficult to figure out exactly what they want. They are against health care reform, but it is unclear why. They talk about death panels and rationing but as I say, that's complete bullshit and if they were truly libertarians they ought to be for rationing, because we're talking about other people's money here. Other than that they didn't like the Wall Street bailout, which is fair enough, although most of their heroes were for it and the main opposition consisted of liberals; and they seem not to like president Obama for largely unstated reasons although we can guess.
We have a guest here who defends the movement essentially on the basis of nostalgia for a romantic vision of the pre-industrial past. When we had to get around on horseback and there was no telecommunication, it was a major project to get a message from Raleigh to Philadelphia, and life was pretty much organized around the plantation and the Town Meeting. Evidently people feel they would prefer to live in what they perceive as simpler times, but it's hard to say what public policy prescription that implies. We can shut down international and interstate commerce beyond what can be carried by horse-drawn wagons, but you won't like it when you don't have fresh vegetables in the winter and you have to weave your own textiles. Electricity and telephones are kind of handy. A complex, large scale society that can produce these things needs a government. That's the world we live in. Wishing you could live in a historical novel is not a policy.
Monday, January 11, 2010
(Don't tell the teabaggers about this blog post, or they'll want to water the tree of liberty with my blood.) As I have emphasized many times, neither the legislation now before Congress, in any form, nor president Obama, proposes that the United States government support cost effectiveness analysis or use it to make or mandate decisions about spending by public or private insurance plans. As another reminder, it is true that the UK does use cost effectiveness analysis in its National Health Service, although mysteriously, Steven Hawking isn't dead.
So what is this evil Nazi procedure? First, remember that it is not, obviously, the sole goal of medicine to extend life. Health care aims to relieve symptoms and improve people's functioning, in other words improve our quality of life. So, if we want to somehow measure and compare the value of medical interventions, we have a difficulty: we need a common metric for quantity and quality of life. As we have seen, you can't just say that life is infinitely precious and therefore death is like checkmate: the king is infinitely valuable compared to all the other pieces. It just isn't so, whether we are talking about the cold fact that resources are not infinite, or people's moral intuitions.
The common metrics are called Quality Adjusted Life Years or Disability Adjusted Life Years. There are various approaches to calculating them. Probably the most common is simply to ask people how much lifespan they would give up to avoid certain consequences. And people are willing to make the trade – the answer is seldom zero. Averages from surveys of many people are used to come up with a number.
Another method is called the Standard Gamble: People are asked to think about a particular health state and then to consider whether they would prefer to remain in that health state for the next 10 yrs or take a chance with a hypothetical treatment. The treatment might return them to perfect health immediately, but might cause instant death. They are then guided to find the probability of cure vs. death at which they are indifferent about getting the treatment. Note that however you do this, and there are other ways, life is not infinitely precious to people.
However you calculate your QUALYs, the next step is to calculate the cost per QUALY gained by a given treatment. In the UK, an agency called the National Institute for Clinical and Health Excellence does this in an open and transparent way, with lay participation, and will generally not approve new treatments that do not deliver above a specified threshold of cost per QUALY, although there are exceptions. Note that this is absolutely not based on assessing the worth of any individual or any particular person’s remaining years of life. The judgment is applied to treatments, not to people. So no, they haven’t allowed Steven Hawking to die because his personal state of disability is irrelevant.
Nevertheless Americans have a very difficult time with this idea. For one thing, it seems to devalue the lives of people with disabilities or chronic diseases. Although we might think today that we would give up some life span to avoid disability, once we actually become disabled, except in extreme cases for some people, our lives do not suddenly become less valuable to us. I am completely sympathetic to that intuition, but it can be argued that it misses the point of how the QUALY concept is actually used. Nevertheless I agree that this is a complicated subject that requires open and respectful discussion. I have no dogmatic prescriptions of my own.
What we must remember, however, is that we already ration health care in the United States, we just do it in a completely indefensible and morally repugnant manner, by individual ability to pay. Right now, in the U.S. People decide every month whether to buy drugs, eat three meals a day, or heat their homes; are bankrupted by medical bills and lose their homes entirely; don't get basic medical care and end up with serious, expensive and completely preventable illnesses that the rest of us end up paying for.
Nevertheless, much of what we spend is wasted. We could actually spend less money and still eliminate this form of rationing.
And remember that even if the British National Health Service won’t pay for a treatment, people who have the money can still go out and buy it on their own. Nobody’s liberty is taken away, it’s just that society as a whole won’t pay for treatments that don’t deliver enough value for the money. So as far as having access to treatment, Britons today enjoy more liberty than we do, in spite of explicit rationing. It is ironic indeed that people who claim to be libertarians are precisely the people who are insisting that society as a whole is morally required to pay for medical treatment for individuals who cannot afford it, regardless of how high the cost and how modest the benefits may be. They obviously haven't even stopped to think for one second what they are actually claiming.
Next: the earth shattering conclusion, which you have already guessed.
Friday, January 08, 2010
That was my own horn. The vox populi often asks, "Why can't we hear more about what the heck you're actually doing when you aren't writing this blog?"
This, among other things. We had this seemingly brilliant idea that if doctors got solid info about how often their patients with HIV missed taking their pills, the docs could talk to the patients about it more effectively and the people would end up taking more of their pills on time.
Sadly, no. What happened is that the doctors talked to the people about taking the pills more, but the people did not subsequently miss fewer doses. Epic fail. Fortunately, we had a lemonade machine. We audio recorded the visits and we had a way of coding them all so we could characterize what actually happened. It turns out the docs mostly just gave the people a hard time about it. Sometimes they threatened the people with death. You might think that ought to work but it doesn't work at all. Once in a while, they suggested specific strategies for remembering better or overcoming problems, but those were all the doctors' ideas -- they told the people what to do instead of inviting them to figure out the problem and come up with their own solutions.
That doesn't work -- these are adults, after all, and if they aren't taking the pills they probably have their own reasons. What we need is to have a non-judgmental discussion about that and see if the physician and patient can't find ways of getting their objectives better aligned and making pill taking actually work for the patient -- conceptually, as a goal, and as a practice.
The fact is, about half of the time, people don't take their pills the way the doctor thinks they should, if at all. A treatment might work great in clinical trials but it won't work in the real world if people don't follow it. Sometimes, especially as people get older, doctors just keep piling on the pills until a person has a dozen or more prescriptions. Very few people actually take all that stuff, almost nobody does it consistently. And they probably shouldn't, come to think of it, in many cases. But they might not be making the best choices about which ones to 86, if they can't have an honest discussion about it with the doc.
So a lot of what I do is related to that problem.
I'll get to the cost effectiveness analysis next, I promise.
Thursday, January 07, 2010
. . . dead. Whoops! He isn't. But as you may recall, Investors Business Daily wrote this about him:
People such as scientist Stephen Hawking wouldn't have a chance in the U.K., where the National Health Service would say the life of this brilliant man, because of his physical handicaps, is essentially worthless.
And that's essentially Sarah Palin's claim as well, that her(?) son Trig, who has Down Syndrome, would be left to die if we adopted "rationing" as those Godless Brits have done. Since Hawking is in fact a subject of HRH Elizabeth II, and he does in fact receive health care which has almost miraculously extended not only his life but also his productive career despite his suffering from ALS, Investors Business Daily obviously got this wrong somehow. But how exactly?
The UK does indeed have an agency, called the National Institute for Clinical and Health Excellence (abbreviated NICE for both historical reasons -- "Health" got added later -- and because it sounds nicer), which does indeed decide whether treatments are worth paying for, and it does indeed include cost as well as benefit in that analysis. What it does not do, however, is pay any attention to who the individual is who is receiving a treatment, or make any judgment whatsoever about the worth of any given person's life vs. that of any other person. There are no death panels. And yet, and yet, there is rationing.
Despite engaging in the Godless Communistic Fascistic practice of rationing, the Brits manage to live longer than we do and be happier with their medical care than we are, as I have recently shown y'all. We just can't have this conversation in the U.S. without screaming mobs descending on the interlocutors with guns on their hips and Auschwitz on their placards, but we're going to have it here anyway, and we're going to get it straight. I'm not saying it's simple, or that there are no ethical difficulties or hard choices to be made. There are, but other societies have managed to make them without collapsing into nihilism. So let's give it a try, okay?
As I pointed out a few days ago, once we get past our initial intuitions about the imperative to rescue people in desperate straits, we do have conclude that there is some limit beyond which it is just not worth spending immense amounts of money for a very small marginal extension of life, even meaningful life. There are other compelling uses for resources and in fact, there are absolute limits. If we spend ten million dollars on one person, that means, a fortiori, that there are other people on whom we can spend nothing, because our resources after all are not infinite. Drawing the line, and rationing resources, do not mean somehow increasing the sum of human deprivation. They mean trying to assure some modicum of justice and making the best use of the resources we do have.
So the question is, how can we go about that in a way that most people will accept as fair? If anyone has thoughts about this, I'd love to hear them. I'll discuss the current state of the art, and my own opinions about it, starting next time.
Wednesday, January 06, 2010
The cause of the oscillation is unknown, and nobody knows how long this negative phase will last. It might not even last the winter, or it might go on for years. While this has no bearing on the accuracy of the anthropogenic global warming thesis -- such variations are expected to be superimposed on the longer term trend -- it certainly could have profound political implications. You probably also know about the 11 year cycle of solar activity. That also happens to be at an unusually strong and long-lasting minimum right now. Again, nobody knows why, but if the sun decides to veg out for a while as well, we could have a few years of cooler than normal weather exactly where most of the people in the wealthy countries live. No matter how much the scientists protest, I am willing to bet the ranch that if people's direct experience is that it just is not getting warmer but instead it's staying damn cold, they aren't going to believe in some mystic claim about what will happen by 2050 and if they do, they're going to be cheering for it.
Fortunately for me, the arctic cold has yet to hit Boston, and it's not in the forecast either. We've had a pretty much normally cold January here. And BTW, it's unusually warm in Greenland. But people aren't going to pay any attention to that.
Of course, the oscillation could turn positive and the sun could perk up starting tomorrow, and we could start melting like a fudgsicle on a summer sidewalk. It all depends.
Tuesday, January 05, 2010
As you may have heard, President Obama has called for investing in something called Comparative Effectiveness Research. The American Recovery and Reinvestment Act (the so-called stimulus package) included $1.1 billion for CER, about $300 billion going to the Agency for Healthcare Research and Quality and the rest to NIH. The legislation also established the Federal Coordinating Council for Comparative Effectiveness Research to coordinate CER conducted or sponsored by the federal government. (You can learn more about the council here.) Some people like to say "patient-centered outcomes research," instead of CER. Same thing.
The health care reform legislation currently being filibustered, ping ponged and sausage ground in congress also addresses CER, but there's a problem. Harry Selker (who happens to be my boss -- I believe we're supposed to disclose such matters) writes:
Although most observers agree on the value of funding CER, many are unaware that embedded in the legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research. In the currently proposed legislation, there are two general constructs for the conduct of CER. The Senate Finance Committee bill mandates the creation of an entirely new private–public research entity and, owing to industry lobbying, guarantees industry three seats on this entity’s 15-member governing board, as well as representation on its methodology committee (the relevant portion of the bill, which may be found at http://finance.senate.gov/press/Bpress/2009press/prb101909.pdf, begins on page 1129). . . .
The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not “within the bounds of and entirely consistent with the evidence.” Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome. This move would be a major retrograde step that would both inhibit the conduct of CER and call its integrity into question.
Don't worry, conflict of interest or no, I'm not inclined to criticize anything Harry says about this. That's Your Congress At Work, as usual.
Anyway, while the pharmaceutical and medical device industry is scheming to corrupt the process, the extreme right -- i.e., the mainstream of the Republican Party -- is claiming that it's all a plot to murder your grandmother. So what is it really?
As Dr. Hadler suggested, it is a strange liberty claim to demand the right to receive useless or harmful treatments, and to have the rest of us pay for them through our insurance premiums. But that is exactly the claim advanced by opponents of Comparative Effectiveness Research.
To get FDA approval, you don’t have to show that a treatment is better than others – you just have to show that it’s better than placebo. Furthermore, you don’t have to show that it extends life or improves health; you can often get approval by showing an effect on so-called surrogate end points, that is biological states that are presumed to be associated with some health benefit, such as cholesterol levels or blood sugar. Often it turns out not to be true. In spite of the effect on the surrogate end point, the treatment doesn’t really make people better off in the long run, and may even be harmful. Yet the follow-up research to find this out, once a drug or device has been approved, is usually not done.
Comparative Effectiveness Research takes no account of cost. It has nothing to do with rationing. It compares one treatment to another, and determines if one is better. That's all. It does not imply 1-size-fits-all or substitute for clinical judgment. On the contrary, one reason to do more of it is to learn more about what works best for what categories of patients. It does not remotely imply denying effective care to anyone. On the contrary, it is intended to generate the information needed to provide people with the best, most effective care. And yet Obama’s endorsement of modest efforts in this regard has been called “eugenics” and “death panels.” This is the level to which public discourse in this country has descended. Who really hates America?
This is all that the president has proposed: to spend more on this kind of research. The product will only be knowledge, not coercion of clinicians, although one can certainly imagine that reimbursement policies might be changed to favor effective, evidence based medicine. That really isn’t in the legislation, except for small demonstration projects, which I’ll say more about momentarily, but it has nothing to do with death panels or Nazi eugenics, I can assure you.
Monday, January 04, 2010
For some obscure reason, many people have come to believe that the Nuclear Winter hypothesis promulgated by Carl Sagan and colleagues back in the 1980s has been discredited. It has not.
Nevertheless, people might be inclined to think that with the end of the cold war and the immediate confrontation between the U.S. and the Soviet Union, the threat of nuclear apocalypse has disappeared. It has not. Alan Robock and Owen Brian Toon calculate that an all out nuclear war between India and Pakistan, using the arsenals they currently possess, would bring about an unimaginable catastrophe.
As the cities of the subcontinent burned, smoke would rise into the stratosphere, above the level where rain can wash it out, and persist there, blocking the sun, for years. As a result, average temperatures in mid-summer in the temperate zones would remain below freezing for five years. As you can imagine, the result would be the extermination of most species of plants and animals, and at least the near-extermination of humanity and the destruction of civilization.
The fact is that India and Pakistan are currently quite hostile and there is a very dangerous state of tension between them including surrogate conflict in Afghanistan and a guerrilla movement of Kashmiri irredentists which includes factions that use terrorist tactics. Meanwhile as long as nations possess nuclear weapons the possibility of other, unforeseen conflicts careening out of control always exists. President Obama has declared a goal of abolishing nuclear weapons but perceivable progress toward this goal is lacking.
Whatever the consequences may be of greenhouse-induced climate change, they will be trivial compared to this prospect. There is no more urgent challenge facing humanity. None. This is it. For so long as nuclear weapons exist, they will be the only thing that matters.
The rule of rescue is important here not only because of the way it affects our allocation of resources, but because it refutes the liberty claim against compulsory insurance. Someone who can afford insurance, but exercises a choice not to buy it, and then is hit by a bus or has a serious illness, will impose a claim on others – family, purchasers of insurance, taxpayers, somebody somehow will pay for their urgent care – and thereby others will be deprived of property and their liberty impaired. No-one can be said to have a right to do that.
The Rule of Rescue, operating not only at the extreme of life threatening contingencies, but even in more mundane circumstances where identifiable people are already less critically ill, fundamentally distorts the way we allocate resources. This is a famous poem in public health circles. It was written in the 1890s, long before the medical institution became the Blob that Ate the Economy.
‘Twas a dangerous cliff, as they freely confessed,
Though to walk near its crest was so pleasant,
But over its terrible edge there had slipped,
A duke and full many a peasant.
So the people said something would have to be done,
But their projects did not at all tally.
Some said, "Put a fence around the edge of the cliff,"
Some, "An ambulance down in the valley."
But the cry for the ambulance carried the day,
For it spread through the neighboring city,
A fence may be useful or not, it is true,
But each heart became moved with pity,
For those who slipped over that dangerous cliff;
And the dwellers on highway and alley
Gave pounds and gave pence not to put up a fence,
But an ambulance down in the valley.
Then an old sage remarked, "it’s a marvel to me
That people give far more attention
To repairing the results than to stopping the cause,
When they’d much better aim at prevention.
"Let us stop at its source all this hurt," cried he.
"Come, neighbors and friends, let us rally.
If the cliff we will fence, we might almost dispense
With the ambulance down in the valley.
(The Ambulance in the Valley by Joseph Malins)
Friday, January 01, 2010
Uwe Reinhardt wrote the following:
The . . . opponents of cost-effectiveness analysis [include] individuals who sincerely believe that health and life are “priceless” — for them, cost should never be allowed to enter clinical decisions. It is an utterly romantic notion and, if I may say so, also an utterly a silly one. No society could ever act consistently on such a credo.
Yes, believe it or not, the James Madison Professor of Political Economy at Princeton University does not believe that human life is infinitely precious. Of course he's going to hell, but what about you? Let me try something out. My colleague Peter Neuman did a survey of oncologists in the U.S. and Canada. He asked them whether they agreed strongly, somewhat, neutral, somewhat disagree, disagree strongly - the usual survey question -- with the following statement:
Everyone deserves access to effective cancer treatments, regardless of the cost.
What's your response? You'll probably be happy to know that most oncologists agree. Then he asked them another question. (I've altered the parameter slightly to get this over with faster.)
Suppose a new treatment for cancer is introduced that costs $200,000. How much added life would it have to offer someone -- let's even say it's you! -- before you would pay for it out of your own pocket? How about if it were paid out of shared social resources? How much extension of life would it have to offer before paying is justified?
One day? One week? One month? Six months? A year? I don't know what your answer is but I'll bet there are very few people who think it's worth spending $200,000 to extend somebody's life by one day. And if you think we are morally compelled to do so, then consider: More than 2 million children die every year from water born diseases; a child dies from pneumonia every 15 seconds; for $250,000, we could save tens of thousands of them.
Why is tobacco legal? Why do people go down into coal mines? Why do we start wars? Every time you get in a car you are proving that the value of life, to you, is finite, because riding in cars is dangerous and lots of people die from it.
The intuition that life is infinitely precious is closely tied to an idea called the Rule of Rescue. Little Timmy fallen down the well is the classic example, but coal miners are a good one also. When miners are trapped under the ground, the coal company and government agencies spare no expense. Drilling equipment is shipped in, high tech seismic equipment, skilled crews work 24 hours, and of course it’s also all the cable news, all the time. If the miners are rescued, the people give thanks to God, although they generally spare him the blame when rescue fails. But the same company has likely been evading safety regulations all along in order to save a few dollars, and the worst that happens to them is a small fine, and there’s little or no public outcry or even any attention paid.
So how we view the preciousness of life depends very much on the obviousness and imminence of death.
The rule of rescue is important to this discussion not only because of the way it affects our allocation of resources, but because it refutes the liberty claim against compulsory insurance. Someone who can afford insurance, but exercises a choice not to buy it, and then is hit by a bus or has a serious illness, will impose a claim on others – family, purchasers of insurance, taxpayers, somebody somehow will pay for their urgent care – and thereby others will be deprived of property and their liberty impaired. No-one can be said to have a right to do that.
Further implications of these observations, which ought to be thought of as very mundane but which are in fact, completely outside the bounds of acceptable political discourse in this country, are to follow.