Stuff that's hard to talk about

This post is inspired by Bridget Kuehn's news story in the new JAMA (off limits, as usual, to the common rabble) about fecal incontinence in women, but the issue is much broader. Kuehn begins, "Fecal incontinence can have a devastating impact on a woman's life, yet few women with this problem seek help from their physicians." New surveys find that the prevalence among women is something like 7-10%, and rises with age. Of course men can have it too, but women are at higher risk mostly because of childbirth -- especially if they've had forceps or vacuum-assisted deliveries. In one of these studies, only 10% of the women who had the condition had consulted a doctor about it in the past year. Physicians can help, depending on the cause, through medication, recommending exercise regimens, biofeedback and, as a last resort, surgery.

Well, there are a lot of important issues that people often don't talk to their doctors about - the obvious ones, of course, are sex, drugs, alcohol abuse. Slightly less obvious is domestic violence, then there's urinary as well as fecal incontinence, itching and rashes in embarassing places, hemhorroids, psychological and emotional problems (mental illness is stigmatized). You can probably think of a few more. The problem is, even though they've seen everything, doctors are still just as socially embarassed as everybody else to talk about these things, unless they've learned to get over it. Most physicians just don't ask about such issues, and if they aren't proactive, patients are unlikely to bring them up. (That explains all those erectile dysfunction ads on TV, of course. The drug companies figure the guys need a push to get over the embarassment, and they know the docs aren't going to bring it up.)

Physicians are also just about as likely as most people to be morally judgmental, and to have their particular hangups. They may not be comfortable with sexuality. (The gynecologist at the student health service where I went to college used to give the young women a lecture about the importance of chastity if they asked for contraception or he determined then to be non-virginal. So that pretty much cuts off communication.) They may be uncomfortable with homosexuality specifically. They may feel helpless or conflicted about what to do in a case of domestic violence, and as for emotional problems, they definitely don't know what to do, they just push pills.

One of the most difficult challenges in fixing medicine is finding ways to help physicians be better communicators, and this is just one more steep ridge in that broad terrain. How do you get people to talk about all that icky, humiliating stuff, and have it be okay?

Yes, you can help

In response to an inquiry, I have determined that it is possible to support humanitarian relief in Iraq by making a donation to the International Federation of the Red Cross and Red Crescent, and earmarking your donation for Iraq humanitarian relief. The web site is here. You can direct your donation to Iraq by selecting Iraq humanitarian relief from the list box next to "I would like my donation to go to:" (I believe that if you make a donation to the International Federation, it is not tax deductible. Whether the American Red Cross makes it possible to earmark money for Iraq I do not know, but I suspect that if you do so, they will just subtract the earmark from whatever they were going to send anyway. That's how they operate.)

However, the Iraqi Red Crescent is having great difficulty operating in the war zone. Our friend Whisker sent me this story.

BAGHDAD, 22 March (IRIN) - Aid agencies say thay have been prevented from entering the city of Samarra, in central Iraq, where a major US and Iraqi military operation is underway.

"Our convoys sent on Sunday and Monday have been prevented from entering the city by US troops and our information from inside is that families are without food, power and potable water, particularly because they cannot leave their homes," noted Abdel Hameed, a spokesperson for the Iraqi Red Crescent Society (IRCS). This, they say, has left hundreds of families without medical assistance and food supplies.

"Innocent people and especially children are suffering from a lack of supplies in and on the outskirts of Samarra," said Muhammad al-Daraji, Director of the Monitoring Net of Human Rights in Iraq (MHRI). "US and Iraqi military groups have prevented the entrance of local NGOs as well as the media to show the reality of human rights violation inside it," he added.

According to al-Daraji, no citizens have been allowed to leave the city, some 120 km north of the capital, Baghdad, since the operation began on 16 March. US forces along with Iraqi commandos say the operation is necessary to flush out insurgents in the area.

So you can help them buy the supplies, but whether the supplies reach the people in need is up to General Casey.

Update on the Parexel incident

A couple of days ago, I wrote about the Phase I trial in the UK in which 6 healthy volunteers were seriously harmed by an experimental drug. At the time, I told you I didn't have enough information to know whether there had been serious ethical violations in this case.

Thanks to Blake for sending me this story by Arthur Caplan which clarifies that indeed, two of the possible concerns I spoke about were warranted. Similar substances had previously caused problems in animals and humans, and the recruitment materials made insufficient disclosure of risk.

Dr. Caplan (who, like me, is not a real doctor but a doctor of philosophy) thinks that having so much human testing done by for-profit companies is a bad idea. That's probably true although people working for non-profits may also have personal incentives -- the desire to get credit for a great discovery, for example -- to cut corners. Recent major scandals in the U.S. concerning human subjects happened at universities -- Johns Hopkins and the University of Pennsylvania. These processes need to be very open, and closely scrutinized by regulatory authorities. Just because an institution claims to have a humanitarian or public service mission doesn't mean the people who work there are all going to behave themselves.

Franz Kafka -- born 70 years too soon

Can't give you a link (subscription only) but the BMJ reports on a Russsian woman whose only son Andrei died without issue, so she had his frozen sperm used to fertilize a donor egg, and the resulting baby was carried to term by a surrogate mother. Okay, so now Ekaterina Zakarova has the grandson she always dreamed of, right?

Not so fast. Since Andrei died two years before the baby was born, he cannot be legally registered as the father. Because the egg donor was anonymous, the baby also does not have a mother. Hence the baby does not legally exist, can't have a birth certificate, and has no relationship to Ekaterina, who is also too old, according to Russian law, to legally adopt him. The Civil Registry office has now gone to court to have the boy placed in an orphanage.

Ekaterina would have been better off, it seems, if she had never tried to get a birth certificate for the baby. When I was a youth, I met a hippie family -- well, semi-hippie, the father worked for the phone company, but they lived back in the woods and had a beautiful marijuana patch -- who decided not to register their son so he would be free of societal hassles. What those hassles were wasn't exactly defined, but in those days we all thought the future would somehow be radically different. A sweet little boy, with no birth certificate, no social security number, no official existence.

I don't know whether they ultimately sent him to school, and I don't suppose he would have needed to prove his existence for that purpose, but I wonder what happened when he first tried to get a driver's license, or a job? Born in the USA, he's an illegal immigrant from the 5th dimension. We all have to be in the computers, there's just no way around it.

Support our troops . . .

Iraqi pharmacist Entesar Mohammad Ariabi, in the U.S. as part of a women's delegation organized by Global Exchange, tells AlterNet about the condition of health and health care in Iraq since the invasion. Read the whole thing, but here's an excerpt:

Many people thought that after the U.S. occupied our country and the sanctions were lifted, the health care of the Iraqi people would improve. But the occupation has made it worse. Many of the Iraqi hospitals in cities like Baghdad, Al-Qaim, and Fallujah were bombed and destroyed. Many ambulances were attacked and health workers killed, despite the fact that it is illegal under international law to attack hospitals, ambulances and health workers.

After our hospitals were bombed and looted, millions of dollars were given to contractors to repair them. We suggested that this money be used to buy things that we urgently need, but the contractors refused and instead bought furniture and flowers and superficial things. Meanwhile, we suffer from a critical shortage of medicines, emergency supplies and anesthesia, and there is no sterilization in the operation rooms. As the director of the pharmacy department in my hospital, I refused to sit on a new chair while there were no sterile operating rooms.

She goes on to describe the public health catastrophe in Iraq today. I won't repeat the details because we have discussed it before. But I do want to connect this to the broader nature and consequences of the military assault and occupation of Iraq. Among some recent items, the much-ballyhooed "Operation Swarmer" displaced hundreds of Iraqi families. U.S. troops killed an entire Iraqi family after coming under attack in Duluiya on Sunday. (An NPR report last night says the Iraqi police are claiming they herded the family into one room and systematically executed them all, including an infant.) Another, similar massacre is alleged to have taken place in Isahaqi on March 15. Then there is the criminal investigation of an eerily similar atrocity alleged to have taken place in Haditha in November.

Here's an interview with former British Special Air Services soldier Ben Griffin in the Daily Telegraph (a very conservative paper, by the way):

I saw a lot of things in Baghdad that were illegal or just wrong. I knew, so others must have known, that this was not the way to conduct operations if you wanted to win the hearts and minds of the local population. And if you don't win the hearts and minds of the people, you can't win the war.

"If we were on a joint counter-terrorist operation, for example, we would radio back to our headquarters that we were not going to detain certain people because, as far as we were concerned, they were not a threat because they were old men or obviously farmers, but the Americans would say 'no, bring them back'.

"The Americans had this catch-all approach to lifting suspects. The tactics were draconian and completely ineffective. The Americans were doing things like chucking farmers into Abu Ghraib or handing them over to the Iraqi authorities, knowing full well they were going to be tortured.

"The Americans had a well-deserved reputation for being trigger happy. In the three months that I was in Iraq, the soldiers I served with never shot anybody. When you asked the Americans why they killed people, they would say 'we were up against the tough foreign fighters'. I didn't see any foreign fighters in the time I was over there.

snip

I can remember coming in off one operation which took place outside Baghdad, where we had detained some civilians who were clearly not insurgents, they were innocent people. I couldn't understand why we had done this, so I said to my troop commander 'would we have behaved in the same way in the Balkans or Northern Ireland?' He shrugged his shoulders and said 'this is Iraq', and I thought 'and that makes it all right?'

"As far as I was concerned that meant that because these people were a different colour or a different religion, they didn't count as much. You can not invade a country pretending to promote democracy and behave like that.

snip

As far as the Americans were concerned, the Iraqi people were sub-human, untermenschen. You could almost split the Americans into two groups: ones who were complete crusaders, intent on killing Iraqis, and the others who were in Iraq because the Army was going to pay their college fees. They had no understanding or interest in the Arab culture. The Americans would talk to the Iraqis as if they were stupid and these weren't isolated cases, this was from the top down. There might be one or two enlightened officers who understood the situation a bit better but on the whole that was their general attitude. Their attitude fuelled the insurgency. I think the Iraqis detested them.

Maybe these things happen, in part, because 85% of the troops think that Saddam Hussein was behind the 9/11 attack, and that they are in Iraq to avenge it. The fish rots from the head.

Reincarnation

I've decided to start posting again occasionally on the Dialogue blog. Anyone with current privileges is welcome to join me. Anyone who wants to get privileges is welcome to inquire. (See e-mail address on sidebar).

Please check it out.

Reflections on a day that shall live in infamy

As usual, I did the Sunday post on Today in Iraq yesterday, which is always a largely grim task, but at least on this occasion -- the weekend before the third anniversary of the invasion -- I had the opportunity to highlight protests and vigils against the war, and memorials for the dead and injured, around the U.S. and the world. Most Americans may have thirsted for some sort of retribution after Sept. 11, 2001, but it took pathological and dishonest leadership -- from both politicians and journalists -- to sell them on this criminal folly. Now that most citizens, and a few humbled news editors, have awakened to the truth, their sense of betrayal and anger is palpable.

But now that the people are starting to grasp reality, we get the really bad news. American democracy is a sham. The putative opposition party is faced with a president who led the nation on a criminal agression with a campaign of lies; demolished a century of progress in international norms of state behavior in the pursuit of grandiose delusions; repeatedly violated the law and the constitution, and fundamental standards of human decency, and claims the absolute right to do so, with no accountability to anyone; and has set the nation on an inevitable path of financial and environmental catastrophe for the sole purpose of further enriching the already obscenely wealthy.

Yet the Democratic leadership is far more anxious to repudiate any suggestion that the administration should be held accountable for its crimes than it is to propose any alternative policies. Most observers predict it is very unlikely that control of Congress will change in the November elections, and one reason -- apart from gerrymandering, the dispositive role of money and television advertising in politics, and the widespread practice of electoral fraud and suppression of Black voting -- is that the Democrats have no message, no policies, no vision, evidently no political ideas of any kind. The supposed front-runner for the Democratic nomination has two big ideas: cheering on the war, and banning flag burning. When a Democratic representative, a decorated combat veteran, calls for withdrawing from Iraq, his Democratic colleagues run away from him like cockroaches scattering in the light -- even though the overwhelming majority of their constituents agree with him.

Anyone care to offer an explanation?

Hostility to Religion

Something I have never understood is the reaction that many religious people seem to have when someone argues for a non-religious belief system. Atheists or secularists or realists or whatever you want to call us or we want to call ourselves know exactly what to expect when we simply state what we believe.

We're "intolerant of faith," "hostile to religious people," "bigoted," "hate filled." Now, I really don't understand this. I don't make the counterclaim. When people profess their faith I don't accuse them of hating me, or being intolerant of my beliefs -- although they often are, obviously. But they have to say or do something specifically to show that before I'll make the complaint. Just saying what you believe doesn't offend me, unless you happen to believe something offensive. For example, I find racism offensive, so if your religion is the World Church of the Creator, I admit to being intolerant of it. But I'm not intolerant of Lutheranism or the International Society for Krishna Consciousness.

I do, however, disagree with them. As they disagree with each other. If you are a Lutheran, then you disagree with Catholics, Jews, Muslims, Hindus, and Parsis as well as atheists. In fact, if you are a Christian, you believe that God is going to torture everybody who isn't a Christian, for all eternity. Now that is hostile. So why do you single me out as hostile and intolerant? I have the same right to my opinion as everybody else, and I don't even go door to door or hand out tracts at the bus station to try to convince you.

I have tried by various means to encourage dialog about belief, between religious and non-religious people, but it seems very difficult to make it happen, because people of faith take it as some sort of insult when other people don't have faith. I don't get that.

This time it's personal . . .

Unlike Rexroth's Daughter's mother (who, scandalously, is not married to Rexroth), my mother does not consult me about the medications prescribed for her, or my father. (See comments on "Don't be Afraid to Ask Questions, below.) She goes along with what the doctors want, no matter what I say.

My father has been diagnosed with vascular dementia. Although his neurologist insists that he does not have Alzheimer's disease, she prescribed Aricept for him, which is approved only for treatment of Alzheimer's. This has never sat well with me because a) there is no evidence that Aricept is of any use in vascular dementia; b) a study of another drug in the same class, Reminyl, found that it increases the risk of cardiac death; and c) oh yeah, there actually is no evidence that Aricept is of any real use in Alzheimer's disease either, or does any real good for anybody.

Aricept is approved on the basis of slightly improved scores on certain mental tests in people with Alzheimer's. However, those "improvements" did not translate into any improvement at all in actual functioning, or any delay in disability or the need for custodial care. So why spend the money and accept any risk whatever?

Now the Japanese manufacturer of Aricept, Eisai Corporation (it's made in the U.S. by Pfizer) decided to do a study of Aricept in people with vascular dementia, so they could market it openly for people like my father, as opposed to whatever covert and possibly illegal marketing Pfizer did to convince my father's neurologist to prescribe it. Whoops -- 11 of 648 patients taking Aricept died after 24 weeks, compared to 0 (zero) out of 326 on placebo. That's quite a lot of dead people in quite a short time -- and all for the biologically implausible hope that they might show marginal improvement on formal tests of cognitive functioning, even if it didn't actually make any difference in their lives.

Guess what the company says? It's just a fluke, nothing to see here, move along, keep taking Aricept. The medical doctors on their payroll say the same thing. I say you'd have to be nuts.

Taking one for the team

I've been holding off saying anything about this drug test in England that landed six people in the hospital with horrific, bizarre symptoms, because I wanted to get more information. C. Corax has tipped me off to this CNN story which actually raises a new question or two rather than answering any.

This appears to have been a trial of a monoclonal antibody ntended to treat auto-immune disorders -- the same general class of chemical as Tysabri, which we have been discussing. (These are based on an important natural immune system mechanism, and are intended to disable specific proteins in a precisely targeted way. The problem is, of course, that even if that works as expected, those very substances (enzymes, or cytokines, or cellular receptors, or whatever) that are being targeted because they are causing problems might also be performing necessary functions, which seems to be the case with Tysabri.)

Anyhow, that's not a central point. This was a phase I clinical trial. That's the standard protocol for exposing human beings to a new, experimental drug for the first time. The purpose is not to find out if it works, but to establish that isn't far more toxic than expected, and to get some information about how it is metabolized and excreted. All drugs are toxic, as are all compounds, for that matter -- it is only a matter of degree. But since drugs are selected to have powerful biological effects, they are generally speaking more toxic than most substances.

So first the drug developers -- usually a private company -- have to feed the compound to animals, probably rats, and establish a safe level. Then a single human volunteer is given a dose 1/100th of the safe level for rats. This person is closely monitored to see if there are any ill effects. Then a second "volunteer" (actually someone who is paid, perhaps a substantial sum) gets a slightly higher dose, and so on through additional volunteers until it is established that doses expected to be therapeutic can be taken without acute safety issues. Usually after the first few, people start to get the dosages in groups.

Now, it should be obvious that Phase I trials can be dangerous. People aren't rats, so we can't really know whether something is safe for humans until we try it. Occasionally, we find out the hard way that it isn't. It may strike you as unethical to conduct a Phase I trial, but somebody has to try it for the first time, whatever it may be. If nobody were allowed to try anything for the first time, we wouldn't have aspirin or pencillin, and for that matter, we wouldn't be able to eat.

So, did this company do something wrong? Maybe. Maybe the dose was too high compared to what had been seen in animal models. Maybe the animal model made no sense at all, if this antibody targets a protein that doesn't even exist in rats. Maybe they didn't do enough animal testing. Maybe the dose was impure and this is a reaction to a contaminant.

The CNN story quotes one prospective subject as saying that he refused to participate because he found the informed consent forms inadequate. That would definitely be an ethical violation. I had thought that this was the first time anyone had received this compound, in which case it would have been a serious violation to give it to six people at once, but the CNN story also quotes an official of the manufacturer, TeGenero, as saying that the drug had not caused problems in previous testing, so evidently this was a later stage. These volunteers were paid quite a large sum -- $3,500 -- and that does raise alarm bells. The ethical theory behind Phase I trials is that people "volunteer" for them out of largely altruistic motives. The money is supposed to compensate them, not entice them. Of course we know that's a fiction.

Finally, if compounds are suspected of being toxic, they are not given to healthy volunteers, but only to people in the late stages of the disease they are intended to treat, who have little to lose. That was not the case here, these were healthy young people who apparently signed up for the money.

The bottom line, after this rambling essay, is that this case may or may not represent a specific act of negligent or unethical behavior, but it doesn't represent a more general sin. Phase I trials, however problematic, are necessary. Every once in a while, something like this will happen, although we don't yet know whether this particular incident was avoidable.

I'm no expert on this . . .

But as a human being, even on this chilly day in March, I have to acknowledge that some of the more alarmist positions on global climate change appear to be quite credible. Some of you may already have seen John Atcheson's jeremaiad on Commmon Dreams. Remember that while increases in atmospheric CO2, caused by human activity, are the main initial driver of global warming, methane is an even more potent greenhouse gas. Excerpt:

In August of 2005 a team of scientists from Oxford and Tomsk University in Russia announced that a massive Siberian peat bog the size of Germany and France combined was melting, releasing billions of tons of methane as it did.

The last time it got warm enough to set off this feedback loop was 55 million years ago in a period known as the Paleocene-Eocene Thermal Maximum or PETM, when increased volcanic activity released enough GHGs to trigger a series of self-reinforcing methane burps. The resulting warming caused massive die-offs and it took more than a 100,000 years for the earth to recover.

It’s looks like we’re on the verge of triggering a far worse event. At a recent meeting of the American Academy for the Advancement of Sciences in St. Louis, James Zachos, foremost expert on the PETM reported that greenhouse gasses are accumulating in the atmosphere at thirty times the speed with which they did during the PETM.

We may have just witnessed the first salvo in what could prove to be an irreversible trip to hell on earth.

Atcheson goes on to note other positive feedback mechanisms which appear to be occurring, such as the recently well-publicized loss of arctic sea ice, melting of continental glaciers, and the decline of tropical forests. The American Association for the Advancement of Science consensus right now seems to be that the most drastic effects of global warming won't be seen until late in this century, by which time I expect not to be around, along with most of you, but the effects we are talking about are horrifying indeed. They include the destruction of the tropical rain forests, much of the current coastline underwater, more powerful and frequent destructive storms, the loss of a continent worth of agricultural land, expansion of pests and disease from the tropics into what are now the temperate regions, etc.

Recently, due to a convergence of events, I have been giving myself an in-depth education about the analysis of risk, and the social perception of risk. This particular situation is unique, in many ways. For one thing, while the scientists who study global climate reached a consensus some time ago that global warming is occurring, due in substantial part to human activity, powerful political interests in the United States, including the current administration and much of the Congress, with funding and inspiration from the fossil fuel industry, enabled by a corrupt and lazy corporate mass media, have created a powerful impression that there is substantial doubt about this, or even that the whole flap is just a vast left-wing conspiracy to destroy capitalism.

But even if there is substantial uncertainty -- as indeed there is about the extent and timing of climate change, and some of the specific effects -- one would think that even a fairly low probability of planetary disaster would cause widespread concern, intense political activism, and a potent backlash against the climate change deniers who have placed us in such grave peril. That it has not may be only in part because of the smokescreen put up by the greedy, powerful interests who profit from fossil fuel.

In general, people seem to be less concerned about risks which are:

1. Not imminent;
   
2. Diffuse in time and space;
   
3. Chronic, as opposed to acute (i.e., this will not be a distinct event but a presumably gradual change in the environment, at least on the human time scale);
   
4. Not fatal (people don't expect global warming to directly kill them or people they know. They may be wrong, but that's likely the general perception);
   
5. Perceptible to the senses (We can tell when the weather is warm, which gives us a feeling of control - and anyway, warm weather itself is experienced as desirable, rather than threatening, in temperate climates);
   
6. Susceptible to individual mitigation (while individuals can't stop global warming, they probably feel they can take action to respond to whatever consequences may affect them directly);
   
7. Not dread (in other words, this is a novel problem, it's not part of our instinctive or cultural heritage of terrors).

Another way of putting this is that the danger is a large-scale abstraction, one that seems remote in time and space, too big to readily grasp, and just outside of the boundaries of people's everyday concerns. Short-sightedness and profligacy, an unwillingness to pay the perceived costs, of doing anything about it, probably also play a role -- as with the people who live in flood zones and on the slopes of active volcanoes.

Anyhow, even if I don't have a whole lot that's new or interesting to say about this, I felt I should join the chorus of alarm. The disastrous Bush presidency has done damage to the United States that it will take us decades to fix, if we ever can. But this may be the very worst of their atrocities, for which our grandchildren will curse them. Our great-grandchildren may not have the chance.

Don't succumb to outrage fatigue

When you're experiencing the death of a thousand cuts, each one may cease to matter, but we've got to keep fighting back. From the Massachusetts Public Health Association:

The Centers for Disease Control, National Institutes of Health, and federal programs that provide the foundation for all state public health infrastructures are threatened with devastating cuts.

The U.S. Senate is currently debating its version of the FY07 budget. Although the Senate Budget Committee reported out a budget that includes more funding for public health than President Bush proposed, it still cuts public health funding from last year.

By $7 billion, in fact. We have already spent $250 billion on the Iraq atrocity, and according to Joseph Stiglitz, who was formerly head economist at the World Bank and is a Nobel Prize winner, along with Linda Bilmes of the Kennedy school, it's going to end up costing us $2 trillion. (PDF). $7 billion is 3.5 thousandths of $2 trillion. That is .0035, or .35%. Very close to nothing, in other words.

Call your Senator and demand support for restoring 100% of public health funding that the Senate wants to cut from the budget. And oh yeah -- demand that we get the hell out of Iraq and stop squandering money and lives in the service of the delusions of a fool.

Don't be afraid to ask questions

Until the mid 20th Century, the generally accepted relationship between physicians and patients in the West was on of benevolent (hopefully) paternalism. The expertise and wisdom to choose the appropriate treatment of disease resided entirely with the physician. The patient's role was to trust the physician and to follow "doctor's orders" --a condition analogous to childish dependency.

Patients ordinarily could be said to have consented to treatment, if only because, as a practical matter, they had to physically submit to the surgeon's knife or swallow the doctor's potions. However, there was no expectation that the patient would be specifically informed about the physician's theory of the patient's disease state, the theoretical basis of the proposed remedy, possible adverse effects, or alternative treatments.

This norm came into serious question after 1950, in connection with broad changes in social attitudes about hierarchy and personal autonomy, and the growing technical complexity of medicine, which, along with more effective treatments, brought increasing uncertainty and tradeoffs among risks and benefits. (In the past, most treatments didn't work and were dangerous, so at least we didn't have to worry so much about uncertainty.)

Now we generally accept an ideal that physicians and patients are partners. While physicians possess expertise about diseases and treatments, the patient is the expert on his or her own tolerance for pain and inconvenience, fear of disability or death, and other subjective factors essential to determining the consequences of a treatment choice for the patient's well-being. And, we believe that self-determination has intrinsic value.

But this is one of those cultural norms that everyone articulates, but hardly anyone observes in reality. We might be able to fool an anthropologist from Mars, but we all know better, or should. According to actual research (the same kind that proves there is more fruit filling than crust in a pop tart), psychiatrists do not routinely disclose the side effects of neuroleptic medications to their patients. Most emergency department patients don't know that they have the right to make treatment decisions. Audiotapes of routine office visits reveal that patients are rarely informed of the risks and benefits of proposed procedures. Many cancer patients who had undergone chemotherapy were found not to recall the nature of the procedure or the risks involved. The basic elements of informed decision making, even using the least stringent criteria, are absent from the majority of clinical decisions -- mostly prescribing of drugs -- in a set of tape recorded general medical visits.

Doctors say that they don't like to tell patients about all the possible side effects of drugs because they are afraid the patients won't take the drugs if they are informed. You know it's true. The last time your doctor wrote a prescription, I'll bet you a free pick in the NCAA office pool that she or he just said, "Take these pills." And you probably did it. Okay then.

The winner and still champion!

Yup, once again, willow bark tea, better known to us as aspirin, beats out the multi-billion dollar blockbuster patented pharmaceutical. At the meeting of the American College of Cardiology, researchers report that the widespread practice of giving Plavix to people who doctors consider to be at risk for heart disease, along with standard low-dose aspirin, is no better than aspirin alone. And oh yeah, it's dangerous.

Plavix was found in smaller trials to be useful as a clot buster for people with advanced heart disease who'd had revascularization procedures, so naturally, doctors started prescribing it for people who they just thought might get heart disease because of high blood pressure or a history of smoking. Good deal for Sanofi-Aventis. It costs $4 a pill and they sold $6 billion worth a year. Now it turns out, based on a randomized controlled trial, that it's no better than aspirin alone for people at risk, and it reduces the risk of heart attacks for people who already have advanced heart disease by less than 1% a year, at best (and maybe not at all), while substantially increasing their risk of bleeding.

So why do we keep getting all these multibillion dollar blockbuster aspiring aspirin substitutes -- from Vioxx to Plavix -- that turn out to be useless and dangerous -- when we could just keep taking aspirin? You know the answer.

Koufax Awards

Stayin' Alive was nominated for a Koufax in the "deserving of wider recognition category," but don't bother voting for me because I'm not gonna win anyway and it isn't important to me.

However, it is important to YankeeDoodle that people vote for Today in Iraq. Here's part of his statement:

Today in Iraq is a blog unlike others. We offer little original commentary. Instead, we aggregate the news from Iraq while trying to present an accurate situation report that you won’t find in the American corporate media.

A reader once wrote me and said we have the worst job in the blogosphere. That reader was right - we document blood, bravery, foolishness and folly.

Speaking from experience, it takes about four to five hours to prepare a news summary. You consult your battle map, research the day’s violence, count the casualties, read about the sacrifices of the soldiers, the determination of the insurgents, and the suffering of the civilians. Then you read the spin and spew our leaders and our media present as they try to convince us that victory is just around the corner and freedom is on the march. The dissonance between reality and rhetoric will drive you crazy as you research and prepare the daily summary.

I’ve already said more than I intended. If you think the editors here are worth your vote, please show your appreciation by casting your vote by posting in comments here. Voting ends at midnight today, Monday, March 13, 2006.

Thanks,

YD

TiI is an important project, providing a new kind of historical document for the age of the World Wide Web. I'm honored to have the opportunity to contribute. So I hope you'll all head over there and give YD what he wants.

An art of sound in time

That is my dictionary's definition of the word "music." One might quibble -- is it the art of sound in time, or are there many musics, as the indefinite article implies? And of course sound only exists in time, it is ephemeral by nature. But the definition emphasizes that the systematic subdivision of time is a universal feature of music (with the possible exception of some recent experimental projects that nobody listens to).

Music is ubiquitous, valued in every culture, and one of the most important attributes of ethnicity and other forms of group identity. The Taliban's biggest mistake, from the standpoint of popular support, may have been trying to ban it. Musicians are among the most celebrated and admired people in the world. But why? What is music for? It is clear why we evolved language, and manual dexterity, and even love is not terribly hard to explain, but music is mysterious. It may be that it has adaptive advantage by creating social cohesion, but other social animals get along fine without it.

Not only is it difficult to explain why we are graced with the capacity, in fact the irrepressible need, to make and hear music; it is difficult for us to explain to each other why we like it, and what it means to us. Music accesses a realm beyond language, represents a dimension outside of space.

The universal foundation of music is, of course, the beat: the steady division of time with a repeated emphasis creating groups of two, or three, or four. In recent times, we sometimes hear 5 or 7 beat measures, but these inevitably resolve into alternating 2 and 3, or 3 and 4 beat segments. In jazz and popular music, the drummer emphasizes the 2d and 4th beats of the measure with the ride cymbal or the snare drum, while the melody and harmonic changes continue to respect the 1st beat. Jazz also subdivides the beat asymmetrically, the property we call swing. These qualities were once viewed as dangerous and immoral.

The other dimension of music, pitch, is organized by successively dividing a vibrating string or column of air into thirds, creating intervals called fifths, and then organizing all of the resulting frequencies -- of which there are twelve -- into the same range by dividing them by powers of two, as needed. That statement will no doubt sound baffling to people who haven't studied music theory, and I won't try to explain it further, but the point is that this esoteric mathematical property of sound, which has nothing evidently to do with biology, provides musicians with an inexhaustible expressive vocabulary. How can it be that manipulating these twelve tones, in sequence and in combination, with a rhythmic pulse, reaches to the profoundest depths of human feeling?

It seems as pointless as the universe of Einstein, Hubble and Darwin, as useless as an altar or a reliquary. But there it is. Part of what we are.

People unclear on the concept

The SecDef testifies before the Senate Appropriations Committee and says that if a civil war breaks out in Iraq, the plan is to let the Iraqi forces deal with it. Uh, Rummie, the idea is, it's a civil war. It's the Iraqi forces that are fighting each other, ¿Sabes?

The Secretary of State then accuses of Iran of meddling in Iraq. Wow, a foreign country that would meddle in Iraq's affairs. That's really evil!

Welcome to the future?

Our friend Blake, at Critical Condition, discusses NIH director Elias Zerhouni's interview in Health Affairs. I have a somewhat mixed view of Zerhouni's vision. He sees, quite correctly in my view, that we are at a major inflection point in the progress of biological science. An avalanche of revelations about biology on the smallest scale, the discovery and elucidation of the fundamental chemical machine parts of life, coincides with exponential expansion of our ability to manage and extract meaning from huge amounts of information. The promise is that we will be able to move beyond the reductionist view of the organism, of disease, and of therapy which dominates medical practice and biomedical research, to a holistic understanding of the human body and ultimately, an ability to stop disease processes before they start.

All of this may well be true. Science really does march on and it is possible that there will one day be a technical fix to the current crisis of our health care non-system. We cannot possibly keep spending ever more and more on trying to control chronic diseases that we cannot cure, by crude interventions that interrupt some part of the disease process while disrupting other essential life processes, leading to secondary effects that we then have to treat with other blunderbuss techniques. Some day, if the neocons don't start World War III and set us back to 1300 AD, we may well be able to proactively regulate our gene expression so that we never get cancer, or rheumatoid arthritis, or atherosclerosis, or diabetes.

But it is going to be a long time before the biological revolution pays off in the way Zerhouni envisions. In the meantime, I don't hear him saying much about the work we need to do to make medicine truly integrative -- of body, mind, spirit and society. We may have a magic nano-bullet that stops diabetes in its tracks by the year 2020, or we may not. But meanwhile, we know that our present epidemic is created by social conditions -- mass marketing of cheap, sugary foods; and sedentary lifestyles spent in front of computer and TV screens and riding in cars. We can't do much to prevent some cancers, but we can prevent an awful lot of cancer by eliminating tobacco use and cleaning up our air and our work environments. Same with heart disease. And no matter what miracles come out of the laboratories, we will still be mortal and we all need to face death eventually, and no doubt sickness and disability before it comes.

Finally, we need to ask whether these miracles of the future will be available to everyone, or only a lucky few, mostly in the rich countries. Social inequality is responsible for most of the world's burden of disease and early death. The cure for that is not going to be found in a laboratory.

Tysabri returns

I'm about to head out of town for most of the day, so I'll just quickly note that an FDA advisory panel, as expected, has recommended that natalizumab, brand name Tysabri, which I wrote about a few days ago, again be allowed on the market.

This is a case in which MS patient activists wanted the drug, in spite of the risks, and there is a lot to be said for allowing people to make such choices, in consultation with their physicians. Indeed, one of the main reasons why the FDA has been less diligent in protecting the public in recent years is because HIV activists demanded an expedited approval process. The problem is that drug company influence resulted in the quicker approval process being hijacked for drugs that are not intended for life threatening or seriously disabling conditions, or for which good alternatives already existed. We need a system that better distinguishes between the amount of risk it makes sense to accept in different situations, and the only way to define "acceptable" risk is to ask the people whose risk is at issue, in other words, potential consumers of medications.

Right now, us folks don't have a real voice in the drug approval process -- it's pretty much a dialogue between drug manufacturers and government experts. There are a lot of other problems with the system of drug regulation, but that seems to be one of them. Yes, members of the public and disease advocacy organizations such as the American Cancer Society can offer comments -- although the ACS doesn't precisely represent people affected by cancer, it has a lot of industry funding -- but I'm talking about something more structured and proactive in reaching out to people affected by medical conditions and getting their input on how to balance risks and benefits. This idea is still a bit vague, but the bottom line is, a more democratic and inclusive process would better serve the public interest.

Con la sangre hirviendo

One way I occupy my copious free time is to talk to community groups about health disparities. Disparities in the health care that people receive are only a part of the explanation for why some groups of people suffer worse health, not even the biggest part, but they still matter, and they are offensive to a society premised on equality.

Last night I spoke, as it happens, in my own neighborhood, which has a large Latino population. A woman from the Dominican Republic, who I will call Malena, told us that last June she found a lump in her breast. She went to her primary care physician, who speaks Spanish, and he sent her on to una especialista, who I presume is an oncologist. The specialist conducted a physical examination, and without ordering any imaging or a biopsy, told Malena through an interpreter that she had a benign cyst, and sent her on her way.

Malena told us that she was still very worried, because her sister died of breast cancer, her grandmother died of ovarian cancer, and her mother had breast cancer. As soon as she could get another appointment with her primary care doc, she went back to express her fears. He again sent her to the specialist, who this time ordered a mammogram, and then reported that Malena indeed had a benign cyst. It was now November.

By February, the lump had grown, and was painful. Malena's primary care physician sent her to the same specialist, for the third time. La especialista said, through the interpreter, that there must be liquid in the cyst, and she would draw it out with a needle. But all she got was blood. So she now conducted a more thorough physical exam and found another lump near Malena's armpit. This time she ordered a biopsy. The verdict? Malena has Stage III B breast cancer. She is scheduled for an MRI to look for metastases. While she was telling this story, her 8 year old daughter came into the room and sat quietly, and sadly, beside her.

Now, I haven't spoken to the oncologist, and I didn't witness any of this. I don't know what might be the outcome of a malpractice suit. Perhaps something about the presentation of this lesion on physical examination and imagery was so atypical of cancer that the oncologist's actions are defensible -- although they probably made the difference between life and death. However, I can hypothesize about a few things that may have gone wrong here.

First, communication through the interpreter may have discouraged taking a thorough history. I have to think that if the onocologist had known about Malena's family history, she would have had a very high index of suspicion. Second, for cultural reasons, and perhaps also because of the language barrier, Malena was obviously very unassertive with the oncologist. I doubt that most women of our dominant anglophone European settler culture would have settled for the answers Malena got without insisting on a biopsy. Clearly she was able to express her fears to her primary care physician, with whom she had a trusting relationship, and he took them seriously.

Finally, we have to consider the question of racism. Would the oncologist have been so casually dismissive and careless of a woman with a similar presentation who seemed more like her friends at the country club in Weston? Just a nasty, suspicious thought.