Reflections Upon an Arbitrary Occasion

We happen to make a major division of our calendar at a time of no particular significance, 10 days after the solstice. Here in North America the days are growing longer but what is normally the coldest part of the year is still ahead of us. In other times and places, people have started the new year at planting time, or allowed it to rotate through the years with the phases of the moon.

Perhaps the turning of the calendar at this time is appropriate for us. The tendency to hibernate is conducive to reflection, as is the challenge of confronting the cold for those who choose resistance over accomodation. I tend to do a little bit of both.

This year, so far, has been the winter that wasn't in southern New England. Yesterday and today have been the chilliest days so far, but that isn't saying much -- temperatures have been in the high 20s overnight and near 40 in the afternoon. A dusting of wet snow yesterday was the first we've had all year, now nearly gone with the morning sun. Even milder weather is predicted for the coming week, beginning with a rainstorm tonight.

And that brings me to the greatest difficulty I have faced as an activist scholar in the past year. It's awfully hard to stay focused and energetic about the issues I study and write about professionally, as important as they are, when the whole world is studying a menu of profound crises, starting with the climate. The health of people who are among the wealthiest, healthiest and longest lived in history just doesn't seem all that important when the planetary biosphere is critically ill.

I console myself for the narrowness of my concerns, and my impact, with the reflection that it is all connected. Injustice, inequality, and unnecessary suffering persist in the United States because our public priorities and political discourse are so perverted. For a fraction of the wealth and passion we squander on creating and wielding instruments of violence, we could readily solve the problems that absorb my energies. The threat of climatic and ecological catastrophe obviously threatens public health, but more than that, the potential solutions also hold promise for mending other deep wounds.

The future of humanity depends on universal acceptance of the power of human reason and its greatest cultural achievement, the institution of science, to explain the world and guide our endeavours. Invading Iraq was a crime, but denying the truth of anthropogenic climate change, along with the underlying foundations of geology, cosmology and biology, was by far the Bush administration's greatest crime against humanity. The criminal conspiracy in the White House denied basic truths about the universe in order to win the votes of people who are exploited and misled, but more directly to protect the wealth and privilege of its sponsors in the oil industry and agribusiness.

The great world historical challenge of our age, to find an accomodation between humanity and its planetary home, is also our greatest opportunity. If we undertake it with clarity and humility, we will win universal cultural acceptance of the habit of seeing the world as it is, as it reveals itself to our senses and our reason, and not as we would like it to be, or have been told it must be by prophets and authorities.

A future habitable world will also have to be a world in which we accept limits, and negotiate to share fairly what we may have.

It will have to be a world without sexism, because equal status for women is the indispensable key to social progress and to a sustainable human population.

It will have to be a world with an appropriate mixture of global, regional and local institutions, both economic and political. We will need to coordinate and arrange our affairs on a planetary level, as one species; while gaining autonomy, community, and local self-reliance as diverse peoples.

It will have to be a world that directs the vast wealth and power we have gained through technological advances and capital investment into human development, including universal educational opportunity, cultural efflorescence, and exploration of the universe, because the ends to which we direct our powers now -- militarism and private acquisition -- are unsustainable.

It will have to be a world without war.

It will have to be a world in which humans live humbly and responsibly, with respect for the ecosystem that makes our own existence possible.

I believe we will achieve all of this because we have to.

LOL

Crooks and Liars grabbed this screen shot, which gave me a much-needed guffaw. It's 100% for real.

Truth, damn truth, and statistics

It's just unavoidable when we're talking about public health, medicine, or for that matter physics and cosmology that we spend a lot of time speaking the language of probability and statistics. People generally feel that they have an intuitive grasp of probabilistic concepts, and that they handle the idea of risk and odds with facility. On the other hand those scientific types go off on less familiar ideas like confidence intervals and correlation coefficients, and really impenetrable concepts like multivariate modeling.

I have tried to present some of the basic ideas as accessibly as I could, here, and another important idea here. But today I don't want to get deeply into the higher mathematics, I just want to ponder probabilistic thinking in general.

As I say, we feel we graps the idea of probability -- odds -- intuitively. But it's actually a very slippery concept. In fact, although scientists rely heavily on probabilistic thinking, the philosophical underpinnings of science have great difficulty with it. The modern philosophy of science has its footings pounded deeply into the positivist idea that the meaning of a statement is equivalent to the method needed to verify its truth. But it isn't entirely clear how statements about probability are verified. If your TV weatherbot says there is a 50% chance of rain tomorrow, she will have been right. Rain or no rain, there was a 50% chance. Or maybe not.

So, when we say that risk factors for stroke include family history, smoking, high LDL cholesterol, obesity, high blood pressure, and diabetes, we don't mean that fat, lazy, french fry gobbling, chain smoking uncle Larry whose parents both had strokes is going to have one; whereas slim, abstemious, vegetarian triathlete brother-in-law Fred whose parents are both 100 years old and compete annually in the world Scrabble championship definitely won't. Out of a thousand Fred's and a thousand Larrys, more Larrys than Freds will have strokes by the age of 50, 60, 70, etc. On the other hand, since a higher percentage of Freds will live to any given age, they will have more time to have strokes and in the end, as we see in the Framingham cohort, about equal numbers will get it in the end.

Social scientists, and the religious cult known as economists, are always trying to analyze such proabilities in terms of "rationality" or "rational choice." Somehow they think they can figure out in objective, unassailable terms, whether the pleasure you get from that french fry is really worth the risks. Then they will give you the relevant information and if you don't do what they say, you're irrational -- a sort of derangement. I even use some of these ideas at times -- such as cost per Quality Adjusted Life Year -- because they offer a convenient metric for making comparisons. But always remember -- shit happens.

There's good news . . .

and, of course, bad news. The good news is that yet another study confirms the general observation that the risk of stroke has been steadily declining in the U.S. (Abstract only to the unwashed.) This is based on the Framingham study cohort, which is not even close to being representative of the U.S. population, so this is mostly good news for middle class white folks.

But what is really interesting about it is why this appears to have happened. The prevalence of smoking in this population declined over the decades, which is probably the most important factor. More people had their blood pressure and LDL cholesterol controlled. These trends were sufficient to overcome the greater prevalence of overweight and obesity, and of Type 2 Diabetes. Since those bad trends are continuing, I would personally fear that the risk of stroke will start to increase again some time soon.

But that's not the bad news I was referring to. It's the age-specific risk of stroke that has been decreasing. The life-time risk has declined very little (actually the decline is not statistically significant in this study, by the conventional definition), because people are living longer. You're less likely to have a stroke in your 50s or 60s than your parents, but you're about as likely to have one eventually. Whatever happens with obesity and diabetes in the future, the aging of the population will continue, and the prevalence of stroke-related disability is bound to increase, even if the age-adjusted risk continues to decline. It doesn't help that when people have strokes when they are older, they are much less likely to recover function. So we continue to have more and more older people with disabilities, even as we continue to improve population health by most measures.

This is a big problem for those of us affected by it directly. (Disclosure alert: I'm among them. As I have revealed here previously, my father has severe disability related to stroke and dementia.) It's also a big problem for society -- for taxpayers, and for our future allocation of resources. Thousands of adult day care centers have sprung up around the country in just the past decade or so. We need more assisted living facilities, more rehabilitation facilities, more nursing homes. Care for the frail and disabled elderly will consume more and more of our wealth, both private and public; more of our individual time, effort and emotional investment; more of our public policy making energies.

A couple more administrative statements

Just in case anybody tried sending me an e-mail between Friday and Tuesday evening around 8:00 pm, I never got it. The changeover to our new e-mail system was massively bejabered and all those e-mails apparently disappeared into a cyber black hole. Please try again.

Also, I'm continuing to read the Bible over at the Dialogue blog -- slowly, erratically, but surely. In church, they only pick out the parts they want you to hear. I'm doing the whole thing. There's still time to get in on the ground floor -- I'm only into the 2d Chapter of Genesis. Dennis Prager says that only people who believe in the "divinity" of the first five books deserve to be called Americans. Well Dennis, I invite you to come on over and let's read them together.

Finally, I'm putting together a Public Health Year in Review. Anybody who wants to nominate one or more highlights, please leave a comment. Or send me an e-mail. You never know, I might even receive it.

Back, and consumer friendly

Sorry for the hiatus -- which was a bit longer than I expected. I had to deal with some family issues, which happen to be relevant to Stayin' Alive, so I expect I'll get to that shortly. For now, though, a reader asked me to comment on an ad campaign that Coca Cola is apparently running boasting that they have donated to the fight against obesity.

I haven't seen the ads, but I'll stipulate that they exist. My response to this is that it's the equivalent of George W. Bush holding a press conference to announce that he is donating to Iraq Veterans Against the War. Coke is not even the sugariest soda out there, but a 12-ounce can contains 27 grams -- almost a full ounce -- of simple sugar. That's 240 calories, or about 10% of all of the calories that a typical active adult should consume in an entire day. Supersize it, and you have the caloric equivalent of a full meal. (By the way, the label on a 12 ounce bottle of Coca Cola claims that a serving consists of 5 ounces, and contains only 100 calories. That is what we in the sociolinguistics biz call a lie.)

Of course, it's not a meal, it's just calories. No protein. No vitamins or micronutrients. No dietary fibre. So either it displaces actual food, and leaves you malnourished; or it adds calories, and makes you fat. And we're talking a lot of real food that you can't eat, or a lot of fatter that you become.

And that's not all. This next part is extremely important. I'm sure most of my readers already know it but if you aren't clear on it, pay attention, because if you don't smoke, this is the most important thing you need to know about your own health. Why is there such a terrible epidemic of diabetes in the United States? It's partly because people are overweight, but that's actually not the main reason.

When we consume carbohydrates, they are converted to glucose, the sugar that circulates in the blood, at differing rates depending on the kind of carbohydrate, and what else we eat at the same time. A sharp increase in blood sugar is called a glycemic spike. When we experience a glycemic spike, the pancreas responds by pumping out extra insulin, a hormone the cells use to take in glucose, thereby reducing the level in the blood. Over time, if we experience frequent, excessive glycemic spikes, the cells lose their ability to respond to insulin, and the pancreas has to pump out more and more of it. Eventually the body loses the ability to regulate the level of blood sugar. That's Type 2 diabetes, which causes terrible damage to the body and then kills you in very unpleasant ways.

The glycemic index measures the contribution of a particular carbohydrate-rich food to causing a glycemic spike. The sugar in Coca Cola and other sodas is actually not the worst kind of carbohydrate you can eat -- that distinction belongs to the simple starch in some kinds of potatoes and refined flour -- but it's pretty bad. The glycemic index of Coke is about 65, which is right up there. It's higher than some potatoes and lower than others, and comparable to white breads. Fruit juices, such as orange and grapefruit juice, in contrast, have much lower glycemic indices, in the 40s. Vegetables, even fairly sugary ones such as carrots (which once had an undeserved bad rep) also have indices in the 40s and low 50s. Furthermore, starchy foods such as bread and baked potatoes are usually eaten with protein and dietary fiber, in sandwiches or complete meals, which slows absorption of the sugar and so reduces the glycemic spike. For this reason, by the way, candy bars, which typically contain proteinaceous ingredients such as nuts and milk, actually have fairly low glyemic spikes. In other words, you're much better off eating a Snickers bar than you are drinking a Coke.

Glycemic spiking is associated not only with diabetes, but with atherosclerosis, heart disease, and strokes. The only time it makes sense to drink soda or so-called "energy drinks" is if you've just been engaging in intensive exercise and your blood sugar is low. Otherwise, that stuff is poison. Quite literally. It contributes nothing nutritionally, and it does a lot of harm. It is sold in food stores, as food, and it's labeled like food. But it isn't food. Don't consume it.

Deck us all with Boston Charlie

This and that:

Thanks to our shy and retiring friend Aunt Deb for for this link to the new American Public Health Association policy position on drug regulation. The APHA, of which I am proud to be a card carrying member, pretty much hits on all the outrages we've been ranting about here. In a chestnut shell:

1. Post-marketing surveillance to detect safety problems is grossly inadequate;
   
2. FDA does not make all of the information available to it available to the public;
   
3. Financial conflicts of interest are pervasive in FDA advisory bodies;
   
4. Drug company influence within the FDA encourages a bias in favor of approval;
   
5. Politics and ideology intrude into the decision making process;
   
6. All-or-none licensing prevents the FDA from imposing appropriate restrictions on drug prescribing;
   
7. Clinical trials do not have to compare new drugs to the best available treatment, but only to placebo. Therefore drugs can gain approval that are actually less effective and safe than existing options;
   
8. Drugs can be approved with very modest effects that are not clinically important;
   
9. Direct to consumer advertising. 'Nuff said.
   
10. The so-called "label" -- the official prescribing information that accompanies every approved drug -- is in tiny print, long, confusing and arcane. MD's don't even read them. Instead, they depend too much on drug company propaganda and the influence of sales reps for their information.

Etc. Once again, the new Congress has the opportunity to take on these issues, but I'm not confident that they will. The drug companies are very powerful on Capitol Hill, but consumers are not. The APHA does lobby, but it doesn't give millions of dollars to candidates. And of course the Occupant still has his veto pen.

Item two: See the side bar for my new e-mail address. My secret identity as mild-mannered social science researcher for a great metropolitan minority community based organization is in greater jeopardy than ever.

Item three: See the side bar for a new blog link. Ibid.

Item four: Blogger has been pushing hard to get its humble subjects to switch to the new version. Atrios gave in to the relentless hounding and Eschaton ended up in Nowheresville for a full day, so naturally I've been resisting. However, I'm going to have to go dark for a couple of days anyway, not because visions of sugar plums will be dancing through my head but because I will be in a very primitive place, a place where there is no Internet. So I will switch and if Stayin' Alive ends up down for a while, it won't matter much because I won't be posting anyway.

How long can a human survive without Internet access? We'll find out. I may get another post in before the Great Lacuna, but if not I should be back on Tuesday. But then again, you never know, a tendril of cyberspace may reach down from the sky and suck a thought or two out of my brain. In any event, Happy New Year, Hannukah, Christmas, Solstice, Festivus, Saturnalia, gratuitous time off from work, excessively interesting family dynamics, colored lights, fat old guy in red pajamas, excessive alcohol consumption, spiritual renewal, orgy of consumerism, charitable giving and volunteerism, or whatever else it is you celebrate, and I'll be back soon.

Evildoers

I know this will be, let's say, interesting to some of our readers. Alex Berenson today in the NYT* reports that Eli Lilly gave information to doctors that was, er, kind of, well, sort of, uhh, not the truth, as such. Actually it was what your personal ethicist might call a lie.

Lilly's biggest seller is the atypical anti-psychotic olanzapine, brand name Zyprexa. It calms hallucinations but it also causes many patients to gain weight, and some of them develop diabetes. It turns out that according to data from clinical trials, 3.6% of people on olanzapine developed high blood sugar, compared with 1.05% on placebo. (Berenson doesn't say so, but this would have been over a short period. The long-term risk is considerably higher.) However, the information they provided to doctors (presumably in the so-called "label," or package insert, although Berenson is not specific) said there was little difference. Lilly also chose not to disclose the results of a study that found that 16 percent of patients taking Zyprexa for a year gained more than 66 pounds -- which is obviously very dangerous.

Now, that degree of obesity is life threatening. So, what's the word for telling lies, with the motive of financial gain, that result in the deaths of human beings?

*Long-term readers may note that the former NYWT has lost the "W," at least for now. We'll see if they continue to merit non-whore status -- they're on probation.

George W. Bush was right

In his press conference yesterday, the Leader of the Free World said, "I understand that we're going to be in a long struggle against radicals and extremists." It's true -- the world does face what will probably be a long-term struggle against extremism, specifically religious extremism. However, Mr. Bush was wrong about everything else.

In the first place, he made this assertion as a rationale for increasing the size of the U.S. armed forces. As he went on to say, "[W]e must make sure that our military has the capability to stay in the fight for a long period of time. I'm not predicting any particular theater, but I am predicting that it's going to take a while for the ideology of liberty to finally triumph over the ideology of hate."

But the U.S. military has nothing to do with this struggle. Finding a "particular theater" where the U.S. can bomb and shoot more people is not going to further the triumph over the "ideology of hate," whatever that may be. Nor is "prevailing" in Iraq, over an enemy unnamed and undefined. Unfortunately, the Democrats in congress are also calling for an increase in the size of the armed forces, so that the U.S. can fight -- whom, exactly? Why? No-one seems to know.

Mr. Bush's second error is his implicit assumption that the enemy lurks abroad somewhere. In fact, in the generational struggle against religious extremism, Mr. Bush is on the wrong side. He is on the same side as Osama bin Laden, along with his friends James Dobson, Jerry Falwell, and Pat Robertson, Anne Coulter, Bill O'Reilly, and Senator Brownback. Their vision of this struggle is that it's a question of which religious ideology prevails, fundamentalist Christianity, or fundamentalist Islam. In fact there is nothing to choose between them. The future of humanity depends on the final defeat of both of these "ideologies of hate."

Finally, he completely omits the essential truth of the War on Terror and the projection of U.S. military power into the Middle East. U.S. elites would not care one whit whether the people of the Middle East were Salafists, Christians, or Flying Spaghetti Monsterians; nor whether the Middle East was governed by a new Caliphate or 6 million individual hippie communes, but for one small matter that Mr. Bush scarcely ever mentions: that stinky black goo under the sand. And muslim "radicals" do not care one whit about our "freedom" and would in fact have no reason to be hostile to the United States at all if the United States did not fill their lands with soldiers for the purpose of controlling that toxic sludge.

That's what's going on in the world. Please, please, let us not increase the size of the U.S. military. John Kerry, shut up.

An Epochal Medical Breakthrough!

Our company has developed a genuine medical miracle. A large scale, 12 year randomized controlled trial has shown that Alivea™ reduces your risk of dying from Himmingburden's disease by two-thirds! That's right, according to a report in the New England Journal of the American Medical Association Archives of Internal British Medicine, people who took Alivea™ daily had a relative risk of .333 (95% CI .23 to .48) of dying from Himmingburden's disease at the conclusion of the trial compared to subjects on placebo.

Side effects of Alivea™ include bad breath, compulsive ass scratching, and inability to see the humor in Marx Brothers movies and other comic stories based on objectively implausible premises, but this is a small price to pay to save your life. Ask your doctor about Alivea™ today and rest assured, Alivea™ can save your life.

Okay, that sounds pretty good. This stuff really can save my life. Now what if I told you that the risk of dying from Himmingburden's disease over 12 years is 1 in 10,000, which means that if 30,000 people take this stuff, at the end of 12 years only one of them will have died from Himmingburden's, compared with three who would have died otherwise? I might also remind you of the sad news that if Himmingburden's doesn't get you, something else will. After we do the calculations, we discover that the average increase in life expectancy from taking Alivea™ is 12 minutes and 37 seconds. And oh yeah, taking it for 12 years costs $17,000.

Not so great after all. The problem is that we have been informed about the relative risk, but not the absolute risk. When you tell people that doing something reduces a risk by half, or two thirds, or some such impressive sounding ratio, they perceive that as a huge advantage. But if you tell them the absolute risk instead, and it is very small, the perception is completely different. It turns out that Himmingburden's disease is not something worth worrying about in the first place.

Lisa Schwartz and colleagues, in the new British Medical Journal, find that the majority of medical journal articles report relative risks in the abstract, but not the absolute risk. About a third of articles don't report the absolute risk anywhere. This has the psychological effect of making interventions seem more beneficial, and risks more grave, than they really are.

I suppose this happens because researchers want their findings to seem really, really important; and because the drug companies that pay for much of medical research and still maintain editorial control over much of the resulting literature want their drugs to seem really, really beneficial. But a much better question to ask is, how many people do we need to treat to get a specified benefit? And, having asked that, how important is that benefit in the context of the other risks and the expectancy for quality life of the individual? Once we ask those questions, the case for intervention usually looks much less compelling.

Arm yourself with skepticism.

People Unclear on the Concept

While the Iraq Study Group report has been helpful in calming some of the more elaborate hallucinations of our psychotic political discourse, it may well have had a counterproductive effect on the underlying delusions. The first half of the report, the assessment of the current situation, dumped a tankful of ice water on the proposition that any sort of "progress" was being made in Iraq, or that something that might be called "victory" was in sight.

However the second half, the recommendations, were clearly tucked and trimmed to be politically acceptable in Washington, and that means that they make no sense and are not connected to the reality depicted in the first half. Sure, some of the ideas about looking at the problem regionally and talking with members of the new, improved and expanded Axis of Evil were constructive (and bound to be rejected by Emperor Chimpoleon), but the core of the proposal, redoubling the investment in the Iraqi security services, is nothing but a proposal to fill the fire tanker with kerosene. The same goes for the proposal, equally acceptable it seems to the ISG and to Harry Reid, to "temporarily" increase the size of the occupation force.

Here's the NYT today, on the Pentagon quarterly report on the situation in Iraq:

The new report, completed last month, noted two parallel trends.

On the one hand, the Iraqi security forces are larger than ever, with 322,600 Iraqi soldiers, police officers and other troops, an increase of 45,000 since August. Iraqi forces also have increasingly taken the lead responsibility in many areas.

The growth in Iraqi capabilities, however, has been matched by increasing violence. That raises the question of whether the American strategy to rely on the Iraqi forces to tamp down violence is failing, at least in the short term.

The Bush administration has decided to step up substantially the effort to train and equip the Iraqi forces. A major question being pondered by Mr. Bush is whether that is sufficient, or whether more American troops are needed in Baghdad to control the violence and stabilize the city.

Hmm. Here's a syllogism for you:

Proposition 1: Iraqi security forces are bigger than ever.
Proposition 2: There is more violence than ever.

Conclusion?

Try this, from the International Crisis Group:

[C]ontrary to the Baker-Hamilton report’s suggestion, the Iraqi government and security forces cannot be treated as privileged allies to be bolstered; they are simply one among many parties to the conflict. The report characterises the government as a “government of national unity” that is “broadly representative of the Iraqi people”: it is nothing of the sort. It also calls for expanding forces that are complicit in the current dirty war and for speeding up the transfer of responsibility to a government that has done nothing to stop it. The only logical conclusion from the report’s own lucid analysis is that the government is not a partner in an effort to stem the violence, nor will strengthening it contribute to Iraq’s stability.

I was listening to the On Point program last night on NPR, where they had Fred Kagan of the American Enterprise Institute, who styles himself a military historian, arguing in favor of the "surge" of additional troops into Iraq. His core rationale, from memory but only mildly paraphrased: "There is a real enemy there. There are evil people who will do bad things if we don't stop them."

Yes, there are evil people in Iraq. As a matter of fact, there are bad, evil people all over the place, including in the White House. But the solution to the existence of evil in the world is not, I am sorry to have to report, the U.S. Army.

The White House occupant actually met with one of those bad, evil Iraqis just a couple of weeks ago, Abdul Aziz Hakim, leader of the Supreme Council for the Islamic Revolution in Iraq, who in that meeting declared his undying love for the occupation and begged to allow the Iraqi security forces to be turned loose against the "insurgency."

As it happens, the head of the Iraqi Red Crescent Society, the only effective humanitarian operation in that country right now, complained just last week that the U.S. military frequently obstructed its operations, and he noted that the insurgents, being Iraqis and concerned about the welfare of the people in the regions they control, were more accomodating. Two days later, Iraqi soldiers from the Interior Ministry, which is controlled by Mr. Hakim, and who are actually members of his private army called the Badr Brigade, showed up at Red Crescent headquarters and abducted half of the staff. The Red Crescent got the message. They have now shut down operations in the capital.

But it is precisely the Democrats in Congress and the liberal pundits who endorse giving Mr. Hakim more soldiers, more weapons, more equipment, more logistical support, and more training, on the theory that this will solve the problems in Iraq.

Here's what "we" must do. We must leave. There is a plausible exit strategy: Climb onto trucks; drive south; wave goodbye on the way.

The International Crisis Group has a number of other very good recommendations about creating a regional suppport group, enforcing equitable distribution of oil revenues among Iraq's various ethnic and confessional groups, etc., but there is no chance in the world the Bush administration will go along with any of that because it requires giving up ambitions to dominate the region and conceding the Middle East to the Middle Easterners.

It might save us a trillion dollars or so, but on the other hand it might not be the best thing for Dick Cheney's pals in the oil business. Still, a fair enough trade in my view.

This has to stop somewhere

Banthin and Bernard, in the new JAMA (abstract here, but you'll have to wait for your faculty appointment to read the whole thing) used data from the Medical Expenditure Panel Survey -- an ongoing project of the Agency for Healthcare Research and Quality -- to track changes from 1996 to 2003 in the percentage of the population under age 65 who are heavily burdened by health care expenditures.

Their method estimates that in 2003, 48 mllion Americans under age 65, 19.2% of all of us who haven't made it to Medicare, lived in families spending more than 10% of their income on health care, and 7.3% in families spending more than 20% of their income. Those numbers may or may not appall you, but what is most important is the very rapid increase in these proportions. In 1996, 15.8% of people lived in families spending 10% or more on health care, with 5.5% spending more than 20%.

The risk is obviously much higher for people with chronic diseases such as diabetes or severe mental disorders, and it is also higher for poor people, including Medicaid and SCHIP beneficiaries, who are spending more and more out of pocket. Indeed, people with private insurance are also spending more out of pocket, and 5.5% of people with private insurance spent more than 10% of their income on out-of-pocket expenses. This means, obviously, that they are likely to forego services that might be needed, and help prevent more serious problems down the road.

Note that if these trends continue at the same rate -- and in fact there is every eason to believe they have been accelerating -- we'll have almost a quarter of the population under age 65 spending more than 10% of family income on health care, and 8.3% spending more than 20%. Since the real wages of American workers have been stagnant for many years, this is coming out of food, housing, education, retirement saving, and other basic needs for most people who already do not have a lot of disposable income.

The burden on society of Medicare is growing even faster, but this adds important context to the debate over what to do about the future of Medicare. In order to finance benefits for elderly people in the future, the workforce will have to be able to make a larger contribution than it does now. But with workers' income also being eroded by health care expenditures, that isn't going to be easy.

As a society, we are just going to have to override the special interests -- drug and insurance companies, the AMA, and others -- who stand in the way of real reform. We are going to have to join the ranks of civilized countries that have structures in place that enable them to get control of this problem. The longer we wait, the worse it will get. There just isn't any choice.

Will we finally learn?

No doubt you have read all about the sudden, sharp drop in diagnoses of breast cancer right after the news came out the Hormone Replacement Therapy was dangerous, and millions of women stopped taking it. The cause and effect case looks quite convincing.*

What the news reports don't give us is the history. Hormone Replacement Therapy (HRT) was approved, and widely prescribed, essentially on the basis of speculation. Women's risk of heart disease goes up after menopause to become more similar to that of men, so it seemed plausible that this might have to do with an estrogen deficiency. There was also a lot of baseless hype about how HRT would keep women youthful and libidinous. None of the Above was the correct answer. In fact it increases the risk of heart disease as well as breast cancer, and it doesn't make or keep you young. All it does is kill you. (It is still prescribed in relatively brief courses to control symptoms of menopause, mostly because the FDA had to give the drug companies some way of saving face and continuing to make money. Even that seems difficult to justify from my point of view, although I have to admit menopause has not been a big problem for me.)

The bottom line is that despite this debacle, and the Vioxx debacle, and so on and so forth, we still have not reformed the drug approval process and we still start to prescribe drugs widely without adequate evidence of safety and effectiveness. Drug companies get to test chemicals against placebo, rather than the best existing therapy, or rig trials by testing them against inadequate or otherwise sub-optimal competing therapies; they get drugs approved on the basis of short-term follow up, insufficient to detect adverse effects of long term use, or delayed effects; they get drugs approved on the basis of so-called "surrogate end points," meaning there is no direct evidence of effectiveness, but only a plausible argument for why they might be effective (viz. HRT, a perfect example of this); there is completely inadequate post-marketing surveillance to detect adverse effects that the clinical trials didn't even look for, or which emerge only in large populations and over longer periods of time; despite some progress in this area, they still get to cherry pick the most favorable trials and suppress studies that tend not to support their products; the researchers who conduct most trials have powerful conflicts of interest, as do members of the FDA panels that evaluate them; and the drug companies aggressively market compounds so that they are often prescribed far more widely than the evidence would support.

In spite of repeated disasters, very little changes. Will the new congress finally force meaningful reform? Stay tuned, but don't hold your breath.

*The drop in diagnoses happened so quickly that it appears to reflect, not a reduction in the actual genesis of new cancers, but rather drastically slowed development of estrogen responsive cancers. In other words, some women actually had minute clusters of cancerous cells when they stopped HRT, which may now develop very slowly, so what we are seeing is at least in part a delay in breast cancer diagnoses, rathe than permanent avoidance of breast cancer. That remains to be seen.

What we can't avoid talking about

I was meeting with a colleague today, on business, concerning subject matter such as we normally talk about here. As we finished up talking about the stuff we get paid to talk about, he stopped me before I could head for the door. What about Iraq?

Yup, it tends to push everything else down the priority list. We just had an election in which the ruling party lost, and everybody agrees that the most important reason was public revulsion over the war in Iraq, the revelation that it was based on a campaign of lies, and its manifest failure. Candidates who ran against the war won all over the country, often in surprising upsets. Public opinion polls consistently show that a substantial majority of Americans want to bring the troops home from Iraq and end this.

So what's going to happen? After spending much of December pretending to "listen" to small groups of hand-picked "experts," selected exclusively on the basis that they will tell him what he wants to hear, the Emperor of Mesopotamia is going to give a nationally televised speech in January in which he announces that he is sending more troops to Iraq in order that We Shall Prevail. While I suspect that he personally has not the slightest idea of what it might mean to Prevail in Iraq, the people who tell him what to think do have an idea. It means keeping the enormous military bases the U.S. has built there, from which they hope to establish military domination over the petroleum resources of the region.

The rest of it is utter nonsense. A "democratic, stable" Iraq is an impossibility any time soon, because Iraq does not have a democratic political culture. An Iraq capable of defending itself is the last thing the United States wishes to establish, because that would mean a militarily powerful but potentially unstable Shiite theocracy closely allied with Iran. In order to ameliorate that unpleasant side effect, they probably intend to bomb Iran, on the theory that it will result in pro-U.S. neoconservatives taking power in that country. And who are we fighting in Iraq? Mostly just Iraqis who don't want the United States running their country. The easiest way to get them to stop blowing up American soldiers and marines is to stop trying to run their country. Then they won't have any reason to blow our people up any more. But that would constitute defeat, so it can't happen.

Meanwhile they are about to ask Congress for another $100 billion down payment on the $2 trillion cost of this grotesque folly. And oh yeah, they're going to build a base on the moon. And the world is 6,000 years old.

The constitution of the United States has failed. If we had a parliamentary system, we would today have a new government. There are many other problems with the constitution, but I'll leave it at that for now.

Yes, we take requests

Or at least we take hints. A reader wrote a couple of days ago. He has been diagnosed with heart disease but he is not interested in having bypass surgery. He's discovered that bypass surgery does not have a substantial benefit in terms of survival,and he's, let's say, a little bit irked that doctors push it on people.

He's basically right. Under most circumstances, the benefit of so-called "revascularization procedures" -- bypass grafts and angioplasty -- is not prevention of heart attacks, but amelioration of the symptoms of angina. It so happens that David Leonhardt, in the New York Times business section, has discussed this issue today, focusing on angioplasty and stents, but it's the same idea. And by the way, in the NYT, the business section is the place to read most of the health care news. Which tells you all you need to know. Controversies over drug approvals, labeling, prescribing and the latest biomedical research are all covered in the business section because they are more about money than they are about health.

Leonhardt writes, in discussing an FDA hearing on the risks of drug-coated stents (an issue much in the news lately):

See, there was an elephant in the hearing room last week that went almost entirely ignored. One study after another has found that whether or not a stent is coated, angioplasty — the process of opening up an artery before a stent is inserted — and stenting do not actually reduce the risk of heart attack or extend life span for most patients.

“There’s a much more liberal use of angioplasty and stenting than there needs to be,” Dr. Eric J. Topol, a member of the panel, told me last week. Dr. Calvin L. Weisberger, the top cardiologist at Kaiser Permanente, said, “A large pool of angioplasties and bypass surgeries are being done without scientific evidence.”

The problem is that there’s nobody whose job it is to say no. The F.D.A. steps in when there are safety concerns. But no federal agency or medical group takes action when an expensive form of treatment becomes far more common than it needs to be — which is a big reason that health care spending is rising so rapidly.

Yup. The Brits, who except for that little problem of having a poodle as Prime Minster are ahead of us in most areas, do have somebody whose job it is to say "no." It's called the National Institute for Clinical and Health Excellence, abreviated NICE because "Health" didn't used to be in the name and it's a better acronym anyway. If NICE says don't do it (NICEly, we hope), the UK National Health Service doesn't. Of course, they have a national health service, so that makes it easier. But we could have a similar institute that lets insurers off the hook for drugs and procedures that aren't worth it.

Only we don't. That would be "rationing" of health care. And we can't have that. Unless you're one of those 45 million people who has no health insurance at all. That's perfectly okay.

Market Failure

That's what economists call it when their Theory of Everything doesn't actually apply after all. Strangely, however, it's a theory of nothing, because markets always fail.

The drug companies spent, I dunno, hundreds of millions of dollars to develop the only two pharmaceutical treatments for dementia which are now available: cholinesterase inhibitors (which work more or less like weak versions of nerve gas); and drugs that block the neurotransmitter glutamate. Unfortunately, they don't do much. The British Institute for Health and Clinical Excellence (NICE), which calculates whether treatments are actually worth it, has decided that cholinesterase inhibitors aren't worth the price. At most, the combination of these drugs can produce a brief interruption in the progression of Alzheimer's disease, after which the course resumes. Of course, we don't have rational health care in the U.S., so they continue to be widely prescribed for people with early dementia.

This new study from the Netherlands, however, finds that occupational therapy -- teaching people with dementia how to cope better with activities of daily living, and working with their caregivers to develop more effective strategies -- has a big effect on both the functional status of the person with dementia, and the sense of competence of caregivers and reduction of their burden. And of course, there are no side effects.

As Jeannette Golden and Brian Lawlor write in an accompanying editorial, "Non-pharmacological interventions in dementia have a long history, but until recently they have not been tested in high-quality controlled trials." In fact this was the very first one, and it was small. Golden and Lawlor go on, "The promising results of this study need to be replicated, and further trials need to be refined and extended. This requires building research capacity and increasing resources and funding to the multi-disciplinary teams that deliver care for dementia in the community." But why hasn't this happened?

Too easy for a hint. There is no gigantic for-profit corporation that stands to gain from such research and infrastructure building. Unlike a mass produced, patented pill, this sort of treatment is produced by innumerable small, non-profit organizations. It can't be monopolized through patents or very high cost of entry. Nobody can possibly get rich from it. So we just shovel out the pills and don't do what actually works.

The new Dutch study, by the way, was financed by the Dutch Alzheimer Association, with extra help from the Dutch Occupational Therapy Association. Obviously the Occupational Therapy Association's members stand to gain business from this, but we aren't talking anything like the financial resources of drug manufacturers. That's why we see so little of this sort of research. Without good evidence, insurers won't pay for such interventions.

Here, take a pill. It's a sacrament in honor of your God, the Free Market.

Faith-based Social Science

Jeff Jacoby, who holds the endowed starboard ideologue chair at the Boston Globe op-ed page, recently wrote that the NYC ban on transfats in restaurant foods "makes men and women less free." Now, since the concept of freedom a fortiori means personal choice, it was easy for me to evaluate this assertion by just asking myself how I felt about it.

Am I "free" because the local pizzeria puts trans fats in the dough? Will I be "less free" if they are made to stop? I really don't think so. I'll probably be healthier and live longer, which will leave me freer to spend my golden years calling Jeff Jacoby a putz, which will make me happy. (Granted, the pizza guy will have to use a different shortening, which might cost him 1/10th of a cent more per pie, or it might not. But he should consider that a price worth paying for keeping his customers out of the Intensive Care Unit, from whence nobody buys pizzas.)

The really interesting question is why people like Jacoby come to such strange conclusions. One reason is that they took an economics course in college. The way economics is taught, the textbook and the professor present a series of so-called "assumptions," and then build from those assumptions an elaborate universe using impressive mathematical tools complete with boffo graphics. This universe is called a "free market," and here, every person strives without any moral consideration to maximize his or her personal satisfaction, which is defined tautologically for consumers -- whatever they do must be it -- and defined, for producers, as monetary gain. The result is the best of all possible worlds, in which everyone is as rich and as happy as they can possibly be. The worst possible thing that can happen is that an evil witch called government mars the perfection of this fairy tale.

The flaws in this Economics 101 course, which is taught to freshmen in just about every college, and nowadays more and more high schools, are not hard to find. The most compelling is that, ahh, actually, none of the assumptions are, well, true. At some point the professor and the textbook will briefly acknowledge this mild embarassment, but then they will forget all about it and press ahead to their conclusions. Another embarassment is that this mystical, mythical, magical free market has never existed, never will exist, and cannot possibly exist, for the simple reason that in order to get people to behave even sorta kinda like they have to behave to make the market work, you need massive, sustained, government intervention. The final embarassment is that in fact, the conclusion that the result of the non-existent free market is the best possible result for everyone does not follow from the assumptions after all. The result may be the greatest possible quantity of stuff and activity that is measured in money, but it is probably grossly unjust and leaves lots of people just plain miserable -- that's even if you believe the rest of the nonsense, which you shouldn't, because it's all false.

I've dealt with some of these absurdities before, for example here, and here, and here. The myth of the free market depends on such nonsensical propositions as: all the costs and benefits to society of any transaction are captured in the negotiations between buyer and seller (e.g., there is no such thing as pollution, or depletion of resources); buyers have perfect information about products for sale and all the alternatives; there are no costs of transactions; everybody has equal access to capabilities and resources; all transactions are voluntary; and so on and so forth.

The mythology also ignores the inconvenient fact that markets do not spring up as forces of nature. They are human social constructions, and in complex modern societies, they depend on continuous, assertive, self-conscious government intervention to function at all. Government creates money and controls its supply; defines contractual obligations and enforces them -- somewhat selectively, depending on the parties' political influence; protects against theft and vandalism -- again, selectively, which becomes a political issue; and provides essential infrastructure which, guess what, the impossible free market does not supply, even according to the theory.

As it turns out, the myth of the "free market" is invoked by politically powerful actors, such as large business corporations and wealthy people, whenever they don't like something government does or proposes to do; and they immediately and shamelessly forget about it entirely whenever they want government to do something for them. It's nothing but an ideological scam used by the rich to defend their privileges. They endow professorial chairs in universities from which the mostly highly paid class of professors churn out mountains of obfuscation proving that rich people deserve to be rich and poor people deserve to be poor, and even if they don't, the worst possible course is to try to do something about it. They give each other phony Nobel Prizes to try to convince everybody that they practice a "science." (There is no Nobel Prize in economics, it's a separate prize of the same name.)

What they practice in fact is a version of theology. Start with your conclusions, and reason backwards. The conclusions in this case happen to be very convenient for the rich and powerful, which is why the whole enterprise continues to be so well-funded and well-respected. How to extract this destructive parasite from our public discourse, from our politics, from our academies, from our minds, is one of our greatest challenges as a society.

Slacker Sunday, a repost

(I'm not really a slacker, I just did the Today in Iraq post, but this seemed timely. Tanta wondered whether an experience I had in the hospital when I was young prompted my interest in physician-patient communication. No, not really, but an experience I had when I was hospitalized some years later did contribute. For background, I had emergency abdominal surgery for what turned out to be a solitary cecal diverticulum, which the surgeons at first thought was cancer, and they acted accordingly. I first posted this in August, 2005. This is a very long post, sorry.)

People are Strange, When You're a Stranger

My roommate, Mr. Karasik, wandered past my bed a few times on his way in and out of the room, pushing his IV pole. Mr. Karasik would stop and talk to me brightly in Russian, holding the pole with one hand, gesturing expansively with the other. I obliged by replying in English. "Yes, the latest red-shift survey certainly does imply a young age for the universe," I might have said.

Mr. Karasik appeared to be in his fifties. He was rather overweight. He wore the obligatory posteriorless smock, and paraded his naked and excessive buttocks without shame. Some exotic injury or disease had caused his lower extremities to be pitted and darkly mottled. Not surprisingly, since he could communicate with no-one in the hospital, he spent much time on the telephone. He seemed happy and healthy; he had not yet had his surgery. But as we were in a surgical ward I presumed his time would come.

I gathered from overhearing what Mr. Karasik could not that he was not in fact healthy. My doctors did not visit him on their rounds; it was a different gang. The leader said, "This man is a pulmonary cripple." Mr. Karasik had Chronic Obstructive Pulmonary Disease. He also was suspected of having bladder cancer. They brought in a translator at one point to talk to Mr. Karasik about logistics, for example that he could have nothing to eat or drink, but no-one told him anything about his condition or prospects.

The next morning Mr. Karasik had surgery. He came back making a lengthy discourse on what I took to be the subject of physical agony. Occasionally he would yell out in real pain. I could not see him as a curtain separated our beds, but it was enough to hear what went on. Nurses would rush in and grotesque activities would follow. They were somehow "irrigating his bladder", which from the sound of it caused gallons of water to drain into a bucket. The objective was to extract blood clots. It was the "long, ropy ones" that caused the major trouble.

Just after midnight Mr. Karasik had his worst attack. Nurses rushed in, followed in a few minutes by doctors. They shouted orders and vital signs at each other. More nurses rushed in pushing equipment. Doctors would ask Mr. Karasik questions, and when he didn't understand, they would ask again, louder. Then they would yell at him. Gallons, barrels, acre feet of water gushed. Mr. Karasik shouted in pain, discoursed angrily in Russian, then muttered and moaned. They called a translator who yelled at him in Yiddish, until she determined that he spoke only Russian. People cursed the hospital for admitting "these people.” Finally the crisis subsided. The Doctor in charge said, "I think he had pain from a clot and he vagaled. He just vagaled."

He never vagaled again, but he started to piss all over the floor as soon as they took his catheter out. I didn't hear them warning him about this -- in fact, I don't think they brought in a translator all week -- and they certainly didn't do anything about it. I discovered it (the hard way) on one of my hourly trips through his half of the room. (By this time, I had severe, relentless diarrhea – more on that later.) I called the nurse to see if we could get it mopped up, but apparently it was the wrong time of day to expect any mopping. When someone finally did come, they didn't mop the lavatory. "Oh, they won't go in there," said the nurse. I didn't blame them, frankly, but I had to go in there, twenty four times a day.

The next day a nurse (who I had never seen before) wandered over to Mr. Karasik's side of the curtain and started telling him, in English, that he was discharged. "You can go home now," she said. He answered in Russian, uncomprehending.

She spoke more loudly. "You can go home. This is a taxi voucher. The taxi will take you home. Here are your clothes," and so on. As he continued, stubbornly, to refuse to understand English, she just turned up the volume. Finally concluding that deafness was not Mr. Karasik's problem after all, she strode out indignantly.

Thirty minutes later she returned with a translator, an earnest young man. The dialogue which follows is reconstructed – put it in Janet Malcolm quotes. But this faithfully represents its essential substance and spirit, to the best of my ability. As I am ignorant of Russian, all speeches in that language, regardless of length or dramatic subtext, are represented by ellipsis in brackets, thus: [...]. Where not credited to a character, the ellipsis represents dialogue between Mr. K and the Translator.

Nurse: Tell him he's going home now. He can give the cab driver this, he doesn't need to pay for the cab. This is his prescription. He needs to get dressed and we'll take him downstairs.
[...]
Trans: He wants to know, will anyone tell him about his surgery, what was the result and what it will mean for him, and so on?
Nurse: Whatever the doctors have told him, I can't tell him more than that.
[...]
Trans: He says the doctors haven't told him anything, he really doesn't know what's going on.
Nurse: Oh for chrissake.

Exeunt nurse and translator. Thirty minutes later, they return, accompanied by an intern.

Trans: [...] Dr. Peachcheek [...]

Dr. P: Well, he has bladder cancer. We took out as much as we could through the urethra, but we just can't get it all that way.
[...]
Dr. P: Unfortunately, it will continue to grow. We think, in three to five years, it will be fatal.
[...]
Dr. P: We can't operate to remove his bladder because he has chronic pulmonary obstructive disease, and he couldn't survive surgery.
[...]
Trans: He wants to know, when the tumor grows, can't you scrape it out again as you did this time? They did it before in Italy, if you can just keep doing it...
Dr. P.: (laughs nervously) Well, eventually he will run out of bladder wall.
[...]
Trans: You mean, every time you do this you use up some of his bladder?
Dr. P: Yes. I mean we could do it again but it would be futile. He will only live for so many years, and we cannot get rid of the cancer ...
[...]
Trans: He says, what about the possibility he has an adenoma? In Italy, they told him it might be cancer and it might be an adenoma, that would be something different...
Dr. P: (surprised) An adenoma? Well, no, no it really doesn't seem to be an adenoma.
[...]
Trans: In Italy they told him perhaps it could be treated with radiation or chemotherapy, is there any possibility you could try some of these things they discussed with him in Italy?
Dr. P: Well, I mean those things could be tried, but I mean ... well, it just would be futile, we can't do surgery to remove the bladder...
[...]
Trans: He says for two days his right leg above the knee has been numb, he has no feeling here on his thigh ...
Nurse: Oh for chrissake.
Dr. P: Well, let me see. (sounds of bodies repositioning) Okay, now I'm going to touch him with my pen, like this. He just needs to tell me when he can feel it.
Trans: [...]
Dr. P: Hmm, Hmmmm.
Mr. K: Da......... Da.
Dr. P: Okay, I'm going to get a neurological consult on this.
Trans: [...]
Exeunt translator and medical personnel. Enter new Doctor, trailed by new intern, nurse and translator.
Intrn: I've been able to find out a little bit about him. He's a fifty-five year old factory worker, and lives alone. He says his legs have looked like that for twenty years.
Doc2: I understand from Dr. Glomerulus that he is a commercial airline pilot. Alright now, tell him this is sharp and this is dull. He is to tell me what he feels, whether it feels sharp or dull.
Trans: [...]
Mr. K: (We all get a quick lesson in the Russian word for sharp and dull.)
Doc2: Well, this is something we see in patients with circulatory problems. You see it maps very cleanly here, this represents damage to the freeblemeyer nerve. It may have happened from lying on his side for too long. It may improve, in time, but usually it will not. He may feel some tingling or it may feel very cold.
Trans: [...]
Exeunt
Enter Translator and nurse.
Nurse: Alright, he's been discharged, he has to go now.
[...]
Trans: He says he can't hold in his urine. What is he to do, he can't get in the cab like this.
Nurse: Oh yeah. Well this is normal after the type of procedure he's had, it will improve in a few weeks. Uhm, we can give him absorbent pads, like diapers.... Excuse me.
[exit nurse]
[...]
[enter nurse]
Nurse: Here.
[...]
Trans: He wants to know what he's supposed to do with them.
Nurse: They just fit into his underwear, he just puts them in his underwear.
[...]
Trans: He is concerned about going out, if he is out of the house for a long time will he be alright like this.
Nurse: Look, my shift is over, I've gotta get out of here. Oh alright. There's another system we can give him, hold on. (exit)
[...]
enter nurse, with apparatus.
Nurse: Okay, this goes over the end of his penis like a condom, okay? Does he know what a condom is? Then he has this bag around on the side of his leg, you see, with this garter belt-type arrangement ...
[...]
Trans: He want to know, won't there be a bulge, won't it show?
Nurse: Well it's up to him what he wants to do. Anyway, tell him he shouldn't use this when he doesn't have to. He needs to try to control his urine; his control will only come back if he works at it. If he relies on the apparatus he won't improve.
[...]
Trans: He says what about his drugs, can't he have his prescription filled here at the hospital before he goes?
Nurse: Oh for Chrissake. Look, we need the bed, there's somebody waiting in the ER for it and I don't have time for this, he was supposed to be discharged this morning. This is really getting ridiculous.
Trans: It's hard for him, he doesn't speak English.
Nurse: Alright, does he have his Medicaid card?
(nurse exits; returns in fifteen minutes with drugs)
Nurse: I had to lean on the pharmacy to get this sent right up. I'm out of here. Goodbye.
(exit nurse. Translator and Mr. Karasik exit a few moments later, conversing in Russian. CURTAIN.)

For once, nature is kind

As we have often discussed here, the blessings of modern public health and medicine have brought with them the curse of longevity: more and more people who live long enough to enter the twilight zone of progressive dementia. Because I believe that, as my wise teacher Shulamit Reinharz said (more or less, I'm paraphrasing) the myth of the disembodied investigator undermines the very foundations of social science, I have also disclosed that my father is one who bears that curse, or more accurately it is my mother who suffers the most from his condition.

One of the most difficult problems facing family members of people with advanced dementia is how agressively to intervene to try to sustain their bodies. Frail, immobile demented people often eat less and less, to the point where it appears they must be starving, and so doctors and family members decide to insert a feeding tube. L. John Hoffer, in the new BMJ, relieves us of this impossible decision.

It turns out that as people enter the slow, terminal, decline their metabolic requirements also decline -- so much so that what appears to us to be a clearly inadequate diet is not inadequate after all. People in that state stop eating because they have no need to eat. Their BMI, obviously, may be very low by the standards of active people, but there is nothing wrong with that; and as long as their weight is stable, there is no need for concern.

Hoffer does point out that there may be specific reasons why people don't eat enough - their dentures don't fit right, or they just aren't being offered desirable food. Many years ago I happened to spend a night in a charity ward (yup, they used to have them) of a hospital in Philadelphia -- a long room with maybe a dozen beds. The man next to me weighed about 80 pounds, but he refused to eat, even though they kept pushing jello and pudding at him. When the nurse left, I asked him why he wouldn't eat. "The food is cold," he said. When the nurse came back, I passed this along. They then brought him a plate of baked chicken, which he devoured.

Hoffer concludes that tube feeding in nearly all cases is likely to do harm, and violates patient autonomy. Even severely demented people will eat if you put appetizing food in their mouths, and if their bodies actually require sustenance. Dementia is still a hard, sad, long road to travel but this conclusion helps a lot. Now let's hope the word gets out to every nursing home and hospice program on the planet.

Administrative Statements

One of my high school English teachers once wrote on one of my efforts at creative writing, "Eschew administrative statements." I have always remembered this, and taken it to heart, even though some years later he was convicted of being a serial molester of adolescent boys. (He never bothered me. Who knew?)

Anyhow, administrative statements are sometimes necessary, so here are a couple. First, if you are interested in voting in this year's web log awards, just click on the logo on the sidebar, and it will take you right to the voting page for best medical/health issues blog. From there you can go right to all the other categories as well. The point of this competition is not really who wins, it's a way of learning more about what's out there in the ever-expanding blogosphere. (By the way, you get to vote once a day for ten days, so you can be a serial voter for one blog, or spread the love around.) Personally, it's getting to the point where I barely have time to read all the blogs I already know and like, but it's still good to discover new ones.

Also, I want to announce that a couple of my friends at Latin American Health Institute have started a new blog about research and policy concerning Latino health, health disparities, and public health in general. I'm helping out as site administrator. It will be on my blogroll as soon as I get around to it.

And now back to work. A real post will appear later today.

The liberty problem

Yesterday's post invokes a much broader, indeed nigh ubiquitous problem in public health, which is the tension, perceived or real, between promoting the general welfare, and liberty, which is a right that pertains to the individual. (Of course, one way to look at it is that individual liberty is part of the general welfare, so we are really talking about trying to balance competing welfare interests. I note this only to avoid getting bogged down in semantics.)

As it happens, this problem turned out to be a salient one in my weekly reading of medical journals this morning. In NEJM, James Colgrove discusses compulsory vaccination, in the specific context of the new HPV vaccine. In JAMA (subscription only, you inferior riff raff), David Kindig, in a somewhat puzzling essay, discusses the idea of a "pay-for-population health performance system."

As we have noted here before, there is something of a social movement challenging compulsory vaccination. 48 of the states allow parents to opt out on religious grounds, but many people campaign for other exemptions, some on philosophical grounds -- a simple assertion that liberty has priority, or a vaguely justified preference for "natural" or "alternative" methods -- and some maintaining that the consensus on the benefits of vaccination is factually incorrect. (Viz. the vaccines and autism scare.) The argument for compulsory vaccination does not have to depend on paternalism, however, because of what is called "herd immunity." If enough people are vaccinated, then people who cannot receive vaccinations due to medical contraindications, or who happen to be missed (such as recent immigrants or poor children who are historically at disproportionate risk of not being vaccinated) are protected. Hence your liberty to refuse vaccination may deprive someone else of liberty from sickness.

In the case of Human Papilloma Virus vaccine, however, this argument is somewhat attenuated, because HPV is a sexually transmitted infection, not transmitted by casual contact. Some parents believe they can teach their children to be abstinent until they enter a monogamous, lifelong marriage with a (presumably) similarly chaste partner. Therefore their daughter has no need for HPV vaccine and giving it to her undermines their moral authority. Of course, my response is that they are very likely to find they are mistaken in their expectations, but that's an empirical question.

Kindig's essay takes off from the movement to "pay for performance" in health care, in which doctors (or hospitals) would be paid more for following standards of care. He is interested in extending this concept to social determinants of disease, such as environmental quality, diet, etc., but the obvious question is, "Pay whom?" He never gets around to making that clear. But the relevance here is that so far, the effective methods we have found for promoting population health are mostly restrictive of liberty, or at least that's what their opponents say.

Smoking bans in public places, laws against drinking and driving, sanitary codes (e.g., you can't build a house without an approved septic tank, or linking to a sewer system and paying a monthly bill), health codes for restaurants and grocery stores, required food labeling, banning junk food in schools, banning advertising junk food to children -- all of these forbid some action, or require people to do something they might not want to do. Hence libertarians are skeptical, if not outright opposed, to many such measures.

It's easy to see that there is another side. The smoking ban in Boston has liberated me to go to restaurants and pubs without having to breathe toxic tobacco smoke. It's worth even more to the people who work there. Sanitary codes liberate us all from cholera and stench, and liberate our waterways from eutrophication and oxygen depletion. Labels on food products liberate me by giving me the power to choose what I want to put into my body. Etc. The point is that the liberty interest is almost never clear or straightforward, it is always a problem of balancing.

And therein lies the essential difference between liberalism and libertarianism. Liberals recognize that the state is not the only entity that can deprive us of liberty. So can business corporations, bullies, and just plain other folks who are careless or indifferent to other people's well being. We need civic order, organized by the state, to find our way through the intricacies of these tradeoffs.

I love New York

for banning trans fats from restaurant food. The only question I have is why the food service industry has opposed this -- not to mention people I can only charitably describe as mindless ideologues who are screaming and yelling about the "nanny state" and "food police." One New Jersey state legislator who tried to introduce a state-wide ban had to shut off her phone service due to abusive and threatening messages. No joke -- that's the "civility" the right wing wackos are always calling for.

For the restaurant industry: If all of your competitors have to do it too, you won't be at any disadvantage. And as a matter of fact, your food will taste just as good, if not better, than it does now. People will be more willing to eat out more often if they know your food won't be killing them. You said smoking bans would put you out of business, and paid millions of dollars for lobbying firms to create phony grassroots organizations to try to stop them -- and then it turned out they actually increase your business. So shut up and stop poisoning us.

For the Soldiers of Freedom: You claim to be opposed to government infringing your liberty, but the fact is, you have no clue what's in restaurant food right now. You aren't making any personal choices, you're just eating whatever it is they shovel at you. The only reason you can do that at all is because you know there are health inspectors making sure the food is refrigerated and handled properly, that the kitchen is clean, and they aren't thickening the stew with cockroach droppings. It's already illegal to put arsenic and cyanide in restaurant food. Are you opposed to that? No sane person would choose to eat trans fats if they had a convenient alternative. If you want to kill yourself slowly, it's still permitted, and there are other good ways of doing it, so you haven't lost a thing.

The very best news is that this will break the log jam, and other cities will quickly follow suit, then many states. Will we get a federal ban? Not until shortly after January 20, 2009, is my prediction.

For once . . .

I'm speechless. Okay, I'll just say this: Oy.

Stealing from Grandma to provide corporate welfare

This extremely wonky report from the Commonwealth Fund will put you in a coma, but these days that's probably not such a bad option. Anyway, here's the take away.

The so-called Medicare Modernization Act (MMA) of 2003 included provisions intended to get Medicare beneficiaries to enroll in private health plans, instead of remaining with the core Medicare fee-for-service system in which Medicare pays doctors and hospitals directly. The Republican Party claimed, of course, that private plans could deliver care more cheaply than those gummint bureaucrats, and that privatization would save the taxpayers money.

You have already guessed the cold truth. Medicare pays the so-called Medicare Advantage plans 12.4 percent more than it would cost to take care of the same beneficiaries through traditional Medicare fee-for-service. That's $5.2 billion a year of your money, or $922 per beneficiary, that's going straight into the pockets of the insurance industry -- which has excellent connections with Congress through it's very well-endowed lobbying operation -- even as Medicare faces long-term funding problems. Will the Democratic congress try to fix this? I'm not holding my breath . . .

Just to make myself clear . . .

I did not say, and certainly do not believe, that everyone ought to take statins, or that we ought to put them in the water supply, or anything like that. What I did say is that research is showing, with an increasing degree of confidence, that certain categories of people who do not currently have symptoms of heart disease show a long-term benefit in terms of both reduced risk of cardiovascular events, and overall survival.

Commenters provided links to more information about statins, and if you are interested this is a group of researchers who are approaching these medications with skepticism, which is appropriate. We should approach everything with skepticism. Their web site has links to various studies and their own summaries of information. I would say that they do get a tiny bit tendentious about some issues. For example, the evidence that statins can cause cognitive or behavioral side effects is extremely weak and conflicting. They give this link to a study under the heading of "statins and memory loss," but when you actually read the abstract, this is the conclusion: "Treatment of hypercholesterolemia with lovastatin did not cause psychological distress or substantially alter cognitive function. Treatment did result in small performance decrements on neuropsychological tests of attention and psychomotor speed, the clinical importance of which is uncertain." These deficits don't apply to most subjects at all, but only emerge when you take the average of all participants, whereupon the investigators find tiny differences that may not even matter.

When you do a study like this and look at multiple endpoints, it is often the case that certain relationships appear to exist which are in fact spurious. This is called the problem of multiple comparisons. Drug companies often rely on such fishing for relationships to claim positive effects of drugs, but it works just as well in the opposite direction, i.e. it's easy to find spurious side effects as well. Obviously, if you think your prescription is having such effects on you, you can stop taking it. You can even do an experiment. Have your doctor ask the pharmacy to give you the drug for two months, and a placebo for two months, but not tell you which months are which. After four months, you'll have a much better idea of whether the drug is really causing problems for you.

The serious side effects of statins are well known, they occur in only a small minority of individuals, and they are usually recognizable well in advance of any long-term consequences. However, it is the case that one statin, Bayer's cerivistatin, posed a particularly high risk for myopathy. It was pulled from the market.

You can read the National Heart, Lung and Blood Institue's summary of what is known about the safety of statins here. (Small PDF) They say this:

More than 50,000 individuals have been randomized to either a placebo or statin in these trials, and no serious morbidity or increase in mortality was observed in the drug treatment groups. These agents reduce the risk of essentially every clinical manifestation of the atherosclerotic process; they are easy to administer, with good patient acceptance. There are very few drug to drug interactions. Although the experience with the safety of statin therapy outside of clinical trials has not been fully reported, it is reasonable to suspect that the incidence of side effects may be higher in clinical situations where patients are not monitored as closely as they are in clinical trials.

I should note that cardiologists have no profit motive here: they don't make much money by writing prescriptions, and if statins do indeed prevent heart attacks, it's costing them business, not helping them. It's not directly relevant to the issues I want to discuss here, but for the record, statins are more clearly beneficial for men than for women, and may not be a good idea for people older than 75 or so. (Which by the way is also the conclusion of the BMJ study I originally linked to.)

My point in reciting all this is not to defend or advocate for the drugs. Rather, it is, as before, to point up some of the epistemological, ethical and pragmatic problems posed by the continual advances in pharmacology -- and there are indeed advances, even though, as I have said many times, the drug companies invest a lot more in "me-too" drugs and "evergreening" old ones (maintaining marketing exclusivity by making tiny changes in formulations), and marketing aggressively to get people to buy their most profitable products, than they do in actually developing new therapies to meet real needs. If statins didn't appear to offer benefits to some people, we wouldn't have an issue. But they do.

So these drugs are an excellent example to focus our thinking about the following problems, among others.

1) Clinical trials are conducted under ideal conditions, and they are designed to look for expected benefits, and not as well designed to look for unexpected outcomes, including side effects. In the real world, drugs may be used less appropriately and less safely, and unanticipated side effects may also emerge, particularly if they are rare. We generally don't have any way of really knowing how safe drugs are when they are first marketed, and we also don't generally invest enough in post-marketing surveillance and further trials to evaluate side effects that we may start to suspect due to anecdotal evidence. There is a pro-drug bias in the way we collect, structure and use information. (That said, the overall safety and net benefit of statins is still holding up well -- but people who argue that we ought to be working harder to learn more certainly have a case.)

2) Drug company marketing often leads to drugs being prescribed more widely than they should be. Statins are certainly a prime candidate for such misuse because they are recommended for some people who don't have patent disease, which means it's easy for "prescription creep" to happen. As I noted before, statins are aggressively marketed because a drug you have to take more or less forever has great profit potential. Each new customer is worth a lot to the manufacturers. The bias that physicians have to "do something" doesn't help either.

3) People's typical personal evaluation of risk is not the same as the actuarial evaluation that is used to generate clinical guidelines. A pill that can reduce the risk of a natural event such as the development of heart disease and myocardial infarction, while posing a lesser risk of an event that would not occur if you didn't take the pill -- in this case myopathy -- might not look like a good tradeoff to the person taking it. This is especially true if there appear to be other ways of reducing the risk of heart disease, such as stringent diet, exercise, etc. -- even though the person is highly unlikely to do those things in reality.

4) The danger that some people may be prescribed statins inappropriately, or use them inappropriately (e.g., they are more risky for alcohol abusers and grapefruit juice drinkers) means that some individuals will suffer harm that can be anticipated, even if the population experiences a net benefit. Do these people deserve compensation? How do these risks affect our evaluation of the entire project of selling these drugs?

5) Is there a substantial hidden cost to labeling people without manifest illness with a disease label, such as hypercholesterolemia, and putting them on a treatment regimen? Do we somehow suffer morally or psychologically from this? Does it make us dependent, or self-involved, or anxious? Is it a misallocation of resources?

6) In the end, can we really depend on the NIH-FDA-medical-industrial complex to give us accurate and honest information so that we can make decisions with confidence? I have offered for your consideration consensus guidelines on statin use and the clinical advisory on adverse effects, but I know that many readers will simply not believe them. I personally am much less skeptical in this case than I am in the case of anti-depressants, for example, but I can understand why people are doubtful.

Further feedback is encouraged. Have at it.

At least I got your attention

My previous post drew a lot of commentary and dissent. I'm going to take the time to read what y'all sent and respond appropriately, unfortunately I can't do it today because I spent the morning doing Today in Iraq and now have family obligations. Tomorrow, I hope.

Meanwhile, you may be interested in a new resolution by the Parliament of Europe on the global HIV epidemic. The European Parliament doesn't have much substantive power, but it does reflect the general philosophy and approach to world affairs of its members. This resolution is a strong contrast to positions of the U.S. -- and pointedly so, I would imagine. Excerpt:

The House Stresses that the strategies needed to combat the HIV/AIDS epidemic effectively must include a comprehensive approach to prevention, education, care and treatment and must include the technologies currently in use, expanded access to treatment and the development of vaccines as a matter of urgency. MEPs call on the European Commission and the governments of our partner countries to ensure that health and education, and HIV/AIDS and sexual and reproductive health in particular, are prioritised in Country Strategy Papers.

MEPs call on the Commission and Member States to support programmes that combat homophobia and break down the barriers that stop effective tackling of the disease, especially in Cambodia, China, India, Nepal, Pakistan, Thailand and Vietnam and across Latin America, where there is increasing evidence of HIV outbreaks among men who have sex with men. The House welcomes the inclusion of research into HIV/AIDS in the 7th Research Framework Programme and calls for research on vaccines and microbicides, diagnostic and monitoring tools suited to developing countries’ needs, epidemic transmission patterns and social and behavioural trends to be supported. The House underlines that women must be involved in all appropriate clinical research, including vaccine trials. Parliament also calls for investment in the development of female-controlled prevention methods such as microbicides, female condoms and post-exposure prophylaxis for survivors of rape.

Access to medicines

The House encourages governments to use all the possibilities available to them under the TRIPs Agreement, such as compulsory licences, and for the WHO and the WTO and its members to review the whole of the TRIPs Agreement with a view to improving access to medicines . MEPs calls on the Commission and the Member States to take the necessary steps in the WTO, in association with the developing countries, to modify the TRIPS Agreement and its article based on the Decision of 30 August 2003, particularly in order to abolish the complex, time‑consuming procedural steps needed for authorisation of compulsory licenses. The House meanwhile, encourages and calls on all countries facing major epidemics to make immediate use of Article 30 of the TRIPS Agreement to access the necessary medicines without paying royalties for patents to the right-owners.

(TRIPS = Trade Related Aspects of Intellectual Property Rights. I don't know why they leave out the "A".)

I'm not exactly sure why this bothers me . . .

Statins would be a drug company exec's dream, if there weren't already perfectly good generic ones available, cheap. The official recommendation is that a large portion of the population take them, every day, for the rest of their lives. That sounds like it means big bucks for somebody but actually, generic statins are now cheaper than the daily paper.

Until recently it wasn't proved that statins really improved life expectancy for people who didn't already have heart disease -- it was just surmised from their effect on the blood lipid profile, i.e. they lower your low density lipoprotein ("bad cholesterol") and raise the HDL ("good cholesterol"). But this large, randomized trial in the UK, along with other evidence, is starting to make it pretty clear that taking cheap, generic statins is well worth it even for people who aren't at particularly high risk for heart attacks. (Please ignore those ads you see on TV for expensive products that are still under patent protection -- they aren't in fact worth it for most people. The companies are just trying to convince you not to take the cheap stuff.)

In fact, I take lovastatin every day. I don't have heart disease, I'm in good physical condition, and I have a pretty good diet. But I still had a fairly high LDL count (it's familial), my father has had a stroke, and my father's father had heart disease, so my doctor felt I should do it. (By the way, it is increasingly the opinion that statins don't only work through their effect on cholesterol. They apparently have other benefits as well, probably through anti-inflammatory properties. Inflammation is now thought to be an important risk factor for vascular disease.)

So, what's wrong with that? Of course, for very poor people, even 25 cents a day is out of reach, but the world is already unjust. Taking a pill might make some people think, okay, that's taken care of, now I don't have to worry about what I eat or getting enough exercise or quitting smoking, and that wouldn't be true. But that doesn't mean that the pill isn't still beneficial for those of us who also do other things right, because according to this British study, it is.

There's still something about the idea of giving everybody a magic pill, even when they aren't sick, that feels a little bit off. But then I thought, why is it different from vaccination? Or nutritional supplementation of the food supply? (As I assume you know, by law milk in the U.S. is fortified with Vitamin D, and wheat flour is fortified with B vitamins. Folic acid was recently added to the requirement, which should have large payoffs for public health.)

Statins do present a risk of a rare but pretty serious side effect called rhabdomyolysis, but that is far outweighed by their beneficial effects. And if you recognize it early, the ill effects should be reversible. Vitamin supplementation does not present such risks, but still, I'd rather have a low risk of suffering rhabdomyolysis than a more substantial risk of heart disease.

This is a new world -- routinely giving powerful medications to large numbers of healthy people -- but apparently it's one we'll have to get used to. I can't really think of any valid objection to it. How about you?