Science of the people, by the people, and for the people?

I just got back from a symposium about so-called community based participatory research (and variations on the name and theme such as just participatory research), in particular an effort at my university to develop more of this kind of research through a center pulling together various resources of the university. I am a kind of avatar of CBPR since I work for a community based organization, while I'm on the faculty, and my research is based in the CBO and guided by the interests and needs of our clients and the organization as a community asset.

Typically, public health research is exploitive of its subjects. An academic, motivated by the need to get grants and publish in order to win tenure and promotions, devises a study using the epistemological standards that are required by NIH reviewers -- randomized controlled experiments of strictly specified interventions, or epidemiological studies that extract information from people according to highly programmed procedures. Then the Big Professor goes away and writes a paper, and the community and people who got studied hear nothing about it and get no benefit from it. It probably has little or nothing to do with anything they care about anyway.

So, there are a lot of Mom and apple pie sentiments that usually define CBPR. Representatives of the community are involved from the beginning in defining the research problem. Community people work with the academic investigators to develop interventions and/ or ways of asking questions. Members of the community get hired as interviewers. The results of the investigation are fed back to the community and the academic investigators work with the community to turn knowledge into action -- whether through education of the public, development of services, or political activism and social change.

Who could argue with that? Well, some people can because they just think that people with Ph.D.s know what they're doing and it's a waste of time and an obstacle to good science to drag the riff raff into it. But even those of us who are passionate advocates for opening up the scientific enterprise and making it a public possession know that it isn't easy. There are a lot of conceptual and practical problems.

I'll talk about a few of them as time goes on but for now, just this one. Who decides who "represents" the community? How do you find those people in the first place to join in and help define the problems and chart the path to answers? Are the people you manage to engage with really "the" people, or are you just buying in to some other, less obvious institutional inequalities?

Stay tuned.

The facts of life . . .

Internet bulletin board services and web hosts, including blogger, tend to be pretty tolerant about content. It's no problem to put up porno, racism and hatred, even incitement to murder. But if you even discuss the following topics (no specification of what you say) they'll shut you down:

Conditional Access Systems.

Satellite Test Cards.

Grantsmanship

Us junior faculty and independent research institute types aren't actually living in the post-industrial age, we're hunter/gatherers. Specifically, we hunt and gather research grants. I spend all my time writing proposals so I never have any actual time to do research.

My big mistake was not shooting into the barrel of fish at the John Templeton Foundation, where they will gladly give you a research grant for a Randomized Controlled Trial of remote intercessory prayer. Sadly, it doesn't cure heart disease after all. (Sisters - you can stop saying the rosary for my male pattern baldness now. I'll still make this year's donation to the Bishop's fund.)

Actually, if the Templeton Foundation and the Discovery Institute want to try to prove that religious beliefs are scientifically supportable, I say, Bring 'em on.

And the Galactic Overlord Medal for Most Outstanding Bullshit . . .

in the Delta Quadrant of the Galaxy goes to -- the envelope, please --

The U.S. Department of Defense for

National Military Strategy to Combat Weapons of Mass Destruction™

The report never actually defines Weapons of Mass Destruction™. I guess we're just supposed to figure they're whatever the Generals say they are at whatever particular time they want to say so. It also never says what the strategy is. Instead, it goes on for 30 pages in the following vein. I've snipped this in various places but it doesn't matter because you wouldn't be able to tell the difference if I did or I didn't.

The strategic military framework to combat WMD consists of ends (the military strategic goal and associated end state), ways (military strategic objectives), and means (combatant commands, Military Departments, and combat support agencies) applied across the three pillars of the National Strategy to Combat WMD (nonproliferation, counterproliferation, and consequence management).

The combatant commands, military departments, and combat support agencies are the means to accomplish MSOs. Commander, U.S. Strategic Command (CDRUSSTRATCOM) is the lead combatant commander for integrating and synchronizing DOD in combating WMD. Consistent with this assignment, USSTRATCOM will integrate and synchronize applicable Department of Defense-wide efforts across the doctrine, organization, training, material, leadership, personnel, and facilities spectrum. Combatant Commanders will continue to execute combating WMD missions within their AORs. Military efforts will need to be integrated with other organizations and nations that possess capabilities, resources, or information that can contribute to the mission.

Strategic enablers are crosscutting capabilities that facilitate execution of the military strategy. They enhance the effectiveness and integration of military combating WMD mission capabilities. Commanders must continually assess enabling capabilities and identify required improvements. Three strategic enablers facilitate DoD’s efforts to combat WMD: intelligence, partnership capacity, and strategic communication support.

The military mission is to dissuade, deter, and defeat those who seek to harm the United States, its allies, and partners through WMD use or threat of use. This mission is in direct support of the three pillars (nonproliferation, counterproliferation, and consequence management) of the national strategy for combating WMD. Across the four military strategic objectives, U.S. Armed Forces may be called upon to carry out eight missions: offensive operations, elimination, interdiction, active defense, passive defense, WMD consequence management, security cooperation and partner activities, and threat reduction cooperation. Capabilities development should address and prioritize the critical capability needs of these eight mission areas. Offensive Operations may include kinetic and/or non-kinetic options (e.g., elements of space and information operations) to deter or defeat a WMD threat or subsequent use of WMD. Elimination Operations are operations systematically to locate, characterize, secure, disable, and/or destroy a State or non-State actor’s WMD programs and related capabilities. Interdiction Operations are designed to stop the proliferation of WMD, delivery systems, associated and dual-use technologies, materials, and expertise from transiting between States of concern and between State and non-State actors, whether undertaken by the military or by other agencies of government (e.g., law enforcement). Active Defense measures include, but are not limited to, missile defense (ballistic and cruise), air defense, special operations, and security operations to defend against conventionally and unconventionally delivered WMD. Passive Defense includes measures to minimize or negate the vulnerability to and minimize effects of WMD use against U.S., partner, and allied Armed Forces as well as U.S. military interests, installations, and critical infrastructure.

Etc., etc., etc.

After you boil out the bullshit, what this says is, we'll bomb, invade or kill whoever we want to, however we want to, whenever we want to, from wherever we want to. Period.

(Thanks to Blake for the link.)

It might not just be the drug companies . . .

. . . who have inappropriate influence on what gets published in the major medical journals. It's the doctors as well -- not in their guise as biomedical researchers and healers, but as a political interest group. Most of the leading medical journals are owned by physicians' associations - associations that represent the political and financial interests of their members and lobby on their behalf. JAMA used to stand for the Journal of the American Medical Association, and that's who owns it. The Massachusetts Medical Society owns the New England Journal of Medicine, and the British Medical Association owns BMJ. JAMA also owns a lot of important specialty journals. (The specialist societies and colleges, such as the Society of General Internal Medicine, which also publish journals, are more focused on research and practice than on the personal interests of their members.)

There have been some significant disputes in recent years about the editorial independence of some of these journals in the U.S. JAMA's editor of 17 years, George Lundberg, was fired by the AMA in 1999 for publishing an article which concluded that 60% college students did not consider fellatio to be "having sex." The AMA board concluded that this was an attempt to downplay the importance of Bill Clinton's statement that "I did not have sex with that woman." (What a country.)

NEJM editor Jerome Kassirer was fired by the Massachusetts Medical Society in the same year for refusing to go along with the Society's schemes to make money by selling the Journal's name and logo to manufacturers of medical devices.

Now, although the lay media in the U.S. have ignored the story (probably because they are afraid to go to Canada to investigate due to the hazard of flying hockey pucks), the excrement has hit the ventilator in the international world of medical publishing, at least, over the firing by the Canadian Medical Association of Canadian Medical Association Journal John Hoey and his deputy Anne Marie Todkill. (PDF) Their crime? They published an article revealing that Canadian pharmacists were asking women who were trying to buy the Plan B "morning after" contraceptive intrusive questions about their sexual histories. The CMA is closely allied with the Canadian Pharmacists Association, which complained about the article. The CMA was already annoyed over earlier articles which had cast some physicians in an unflattering light.

This story continued, with Jerome Kassirer brought in to do an inquiry, the CMA apparently not accepting his conclusions that the journal should have editorial independence, and most of the editorial board resigning.

Medical journals must not have a mission of protecting the interests of physicians, as particular associations of physicians construe them -- and let's not forget that many U.S. physicians are not members of the AMA and do not approve of its policy positions. They must represent the public interest. Perhaps we need a new model of ownership.

A confusing decision, but one you need to make

The subject of screening tests comes up here a lot. There are a lot of these tests that doctors really like to do, and to most people, it seems obvious that there's nothing to lose by having a test that might catch cancer or some other serious condition early, while it's easier to treat. The story is not nearly so simple, but most of the time our doctors don't burden us with the complexities, they just tell us to get the mammogram or the Prostate Specific Antigen test, and we do it.

I've written in the past about Bayes' Theorem -- how even a highly specific test (one that only reads positive in a small percentage of people who don't have the disease) can be wrong most of the time when the underlying prevalence of a disease is low. But the issue with breast and prostate cancer screening is even trickier. The problem is, we aren't even sure what constitutes a false positive.

Some proportion of these cancers -- in the case of prostate cancer, we know for certain that it's actually a majority -- will never cause a problem. Either the person dies of something else before the cancer becomes clinically significant, or the cancer is what is called "indolent," that is it doesn't grow very much and it doesn't metastasize, it just sits there. Is that even cancer? It's a semantic quibble -- the problem is that we don't know how to tell them apart from the ones that will go on to cause trouble.

So if you're considering screening, you have to weigh the possible benefits -- that you might find a cancer early, when it can be effectively treated, that would eventually have killed you otherwise -- vs. the costs and risks, which include the possibility that you will end up having surgery, and/or radiation, and/or chemotherapy, with attendant risks, pain, high monetary cost, and in the case of mastectomy disfigurement, and in the case of prostatectomy incontinence and erectile dysfunction, plus the anxiety and general sturm und drang for yourself and your loved ones, all for no good reason at all.

A new study by Zackrisson, et al, published in BMJ, based on a randomized controlled trial of screening mammography done in Sweden in the 1970s, estimates the rate of overdiagnosis to be 10%. They got this number in a simplistic way: 15 years after the trial ended, there had been a total of 10% more cancers found in the screened group than in the unscreened group. The logic is that that many additional cancers must also have existed in the unscreened group but never caused a problem and so were never detected.

But as some letter writers point out, this is actually a considerable underestimate of overdiagnosis. Gilbert Welch, Lisa Schwartz and Steven Woloshin of Dartmouth note that real issue is the percentage of cancers found by screening that represent overdiagnosis. Since some cancers in the screened group were not found by screening but by clinical diagnosis; and as cancers in both groups continued to accumulate after the trial ended 15 years ago, the percentage of positive mammograms that represent what they call "pseudocancer" was 24%, not 10%. Peter Gotsche points out that some of the women in the control group actually got screening mammograms after the trial ended, which pushes the rate of overdiagnosis up even higher. He thinks at least 30% is the right number.

Now that doesn't mean you shouldn't get a screening mammogram. Important additional considerations include your personal risk factors (e.g., if your mother or sister has had breast cancer, or you haven't had children, you might be more inclined to be screened), and how averse you feel personally to the treatments for breast cancer, as well as your age and your philosophy of life. There is reasonably good evidence that in the long run, screening does reduce the breast cancer death rate in a population, so all things being equal it might give you a chance of living longer -- but it's a small chance.

What I advocate for is not screening or not screening, but knowledge, and autonomy. Doctors should inform women much more fully about these issues than they typically do. Rather than blindly following recommendations from such bodies as the American Cancer Society (which have a vested interest in promoting treatment since they are closely allied with drug companies, surgeons, radiologists and oncologists), women who are so inclined should make up their own minds.

I'll get to prostate cancer screening another time.

Back on the job

The new Gallup poll says it all.

What's the number one concern of American voters? Is it the War on Terra? Is it saving the blastocysts, or the brain dead? Is it keeping homosexuals in the closet? Is it illegal immigration, or crime, or drugs, or even social security? Nope. It's

The availability and affordability of healthcare

68% of respondent say they worry about that "a great deal," up from 60% last year, and leading the list of voter worries not by a little, but a lot. Social security comes in second, at 51%. And guess what? Democrats worry about it the most, but it is the leading concern of Republicans and independents as well.

So then, who should win the November election? If we can avoid getting drawn into a lengthy discussion about The 10 Commandments, flag burning, the homosexual agenda, and who eats brie, I think the answer is obvious.

But then, if the Democrats reclaim Congress, will they stop listening to the voters, and just listen to the lobbyists? Watch this space.

The desperate character writhes again . . .

I started this blog mostly as a form of self-discipline. I have often attempted to keep a journal of my professional interests - to write every day about the subjects I study and the work I do - but the project always seemed to lapse after a while. When web logging came along, it seemed to offer that essential psychological prop - the illusion, at least, that there was an interlocutor out there, somebody reading. As with cooking, that makes writing more satisfying, gives me an incentive to do it at least acceptably well, and gives me a kick in the pants to do it at all lest I let my reader down.

Well, it worked. I have indeed written every day now for about a year and a half, except for some Saturdays when, as long time readers know, I am out in Windham County Connecticut, building a house. Sundays I usually get off the explicit topic of public health and say something vaguely philosophical. With those indulgences, I've been able to keep it going. Even better, I actually have readers -- I presume the number is modest, but the commenters here are fabulous. I can hardly believe the knowledge, wisdom and good humor of the people who contribute. That makes it worthwhile. I've also been able to spin off some other activities in the blogosphere from this site, and it's all been very gratifying.

So, now, I feel some responsibility to meet expectations, to have a clear definition of what I'm doing here that is both potentially of interest to others and within my capabilities to do well, and to try to keep improving. My biggest challenge, it turns out, is limiting the terrain. Public health is about, well, everything. It provides some standard analytical tools, it adopts scientific theories of knowledge, and there are some topics that people in public health tend to focus on, such as disease entities and their causes and prevention (with treatment a less prominent concern), health disparities, concepts of well-being, measurement problems, etc. But really, if it has to do with Homo sapiens, it has to do with public health.

And right now, I'm mostly worried about subjects that don't get a lot of ink in the American Journal of Public Health. We aren't going to get any positive changes in public health or health care policy so long as the present gang remains in power, and ven if they collapse like Enron, we'll be digging out of the wreckage for decades. It seems feckless to write about social and economic disparities in health, the Millenium Development Goals, the obesity epidemic, the nefarious pharmaceutical industry, pathogen drug resistance, the marginalization of mental health, the Rule of Rescue and the perverted priorities of health care, environmental justice, and all those other subjects that have occupied us here, when the country is ruled by a gang of murderous thieves who are doing everything in their power to destroy any chance we have to make progress on these problems.

The public discourse in this country right now is utterly inane. A headline in my local birdcage liner today read "Two lawmakers call on the president to obey the law." Which means that 533 did not. $10 billion a week of money the U.S. government borrows from the Chinese and the Saudis goes down the rathole in Iraq, which just descends deeper into nightmare. Corporate CEOs are paid tens of millions of dollars a year while their employees don't have health insurance and their standard of living keeps going down. We keep spewing more and more CO2 into the atmosphere, climatic catastrophe approaches, while our political leadership claims the entire issue is nothing but a left-wing fabrication intended to destroy capitalism and the corporate media continue to portray it as a political dispute rather than a settled scientific question.

I'm could continue but I'm sure you can extend the list as well as I can. So we have a democracy, right? The people can put a stop to this, right? Elections in this country are contested over the issue of whether the earth is 10,000 years old and whether letting some people get married will destroy everybody else's family; whether people who say that we should pursue national security by trying to apprehend people who actually attacked us or plan to, rather than invading unrelated countries in order to control oil fields are traitors; and whether candidates drink beer or wine. All of this critical thinking is disseminated by means of television advertisements, which means the real fundamental issue is who can get people and corporations to fork over hundreds of millions of dollars to spew this dreck into people's living rooms.

Sometimes, in other words, I feel like I just can't go on. But, now that I've got that out of my system, I will. Thanks for your indulgence.

An Apology

I feel I haven't been keeping up with the public health blogging as much as I would like recently. I have been distracted by some other matters, including, obviously, Iraq. There are a few issues which I feel I should have written about in the past week. I'm saving them up, and I'll get to them, but for the rest of today I'm going to be composing my feelings about the current state of affairs and I may not post until tonight or tomorrow.

It's very gratifying to see some new visitors here. Don't worry, we'll be back on topic soon.

Moral Values

A few years back, police in Hudson, Wisconsin were baffled when an undertaker and his apprenctice were found shot dead. It soon emerged that a Christian organization, the Rest of Jesus Ministry, had been sending threatening letters to funeral homes around the state:

Thus saith the Lord, because you have heard not the words of the Lord, I take from you your sons and daughters into early graves. And prepare for burial yourself. Amen.

It turns out that the Rest of Jesus Ministry is led by Kathryn J. Padilla of Lincoln, Wisconsin, who speaks in tongues and is believed by her followers to be a prophet. According to the Ministry,

Respect for the body comes by wrapping it in white linen and laying it in a place prepared -- pickling of the body, by the draining of the blood, by the draining of the leftover blood, is an abomination to Me and this practice must cease! Failure to comply to cease from the pickling of the body and the adoration of the dead, will bring a judgment of much death upon this land.

The group denied involvement in the murders and as far as I can tell, they were never solved.

Back in 2002, a Hindu scholar wrote a book demonstrating that beef was routinely eaten in the time of the Vedas. Due to death threats, he was obliged to accept police protection. The publisher withdrew the book. But in fact Indian scholars have known this for well over a century.

Real Truth Ministries of Keene, Texas, invites me to a Revelation Seminar, A Biblical Prophecy Adventure. There, the visions of the apocalypse will be made simple and understandable. Who is the Antichrist? What is the Mark of the Beast? 88 Golden Keys to Unlock the Symbols.

Vineyard Christian Fellowship of Cambridge invites me to join them. Is Jesus Good? the flyer asks. Their members have the answer. "Jesus healed me of breast cancer." "Jesus has financially provided for me." "Jesus healed our unborn baby's heart condition." That Jesus is a good guy, for sure, although it's kind of too bad that there so many other people whose breast cancer he hasn't healed, who he hasn't provided for financially, whose babies were born with heart conditions after all. Maybe he's only good when he's in a good mood.

Then there's Tony Alamo, pastor of the Holy Alamo Christian Church of Alma, Arkansas, and Canyon Country, California. I held on to his literature because it contains the only plan of salvation, and he warned me not to toss it. God has given Tony many visiosn, signs wonders and messages that he hasn't written about previously, but Susie and Tony have had an experience with UFOs. I won't go into all the details but it turns out that "God, Who is the Truth, tells us that every abomination on earth comes from the devil who has chosen Rome as the center for his cult and for his government. . . . Noone must know that his church, his false prophet, and hsi one-world system is the incarnation of Satan."

Saint Matthew's Churches of Tulsa Oklahoma has sent me a Holy Annointed Prayer Rug. It's soaked with the power of prayer. After I use it, I just need to send it in to them with my prayer needs checked off on the letter they sent me -- a better job, a new home, a new car, my health -- you name it. Satisfied customers write that "God blessed me with %5,000," "I received $10,000 in a financial blessing," "God made it possible for us to buy 17 acres of land, "I've gotten a new car and a job," etc.

All very amusing. But if you think these religious beliefs are wrong, how do you know that yours are right?

And, relevant to the below

Here's a link from Blake to an article on Jay Cohen's Medication Sense site, discussing drug industry corruption of the medical profession. Dr. Cohen points out that it's not just a matter of individual physicians being influenced to push drugs inappropriately in exchange for the ball game tickets, the note pad and the triangular pen -- it goes right up the ladder to the highest levels of the medical institution.

I like Cohen's site, I hope you'll check it out.

A Scientific Circle Jerk

We (the We being royal) have written on a few occasions about the dubious evidence for the efficacy of antidepressants. (Here's the key post.) Now, in one week, our two leading medical journals have come out with major research reports which are intended to persuade doctors to prescribe more antidepressants. Both journals made a big PR push on these "studies" (we'll get to the scare quotes momentarily), so you may have read about them in your favorite bird-cage liner.

Since, unlike We, you are mere commoners, you can only read the abstracts, but that should be enough. In the New England Journal of Medicine we have Bupropion-SR, Sertraline, or Venlafaxine-XR after Failure of SSRIs for Depression by Rush, et al; and Medication Augmentation after the Failure of SSRIs for Depression, by Trevedi, et al. In JAMA, we have Remissions in Maternal Depression and Child Psychopathology, by Weissman, et al.

The JAMA article finds that children of depressed mothers do better when their mothers' depression improves. (Another open door crashed through.) Their conclusion? "These findings support the importance of vigorous treatment for depressed mothers in primary care or psychiatric clinics and suggest the utility of evaluating the children, especially children whose mothers continue to be depressed." There is only one problem with this conclusion: 100% of the mothers in the study were being vigorously treated. Some of the mothers improved during the course of the study, some did not. The study provides no evidence whatsoever that the treatment made any difference.

Then there are the two NEJM articles. Both of them report on similar strategies: people who were taking antidepressants, who did not improve, were switched to other antidepressants or given additional ones. In both cases, about 30% of them eventually showed some improvement. Again, however, 100% of the patients in both studies were being treated. There was no control group in either study. Depression sometimes remits on its own, given time, and the placebo response in depression is very strong -- as a matter of fact, it's at least 30%. (What a coinkydink!)

In other words, it's no longer considered necessary that research using antidepressants actually provide any evidence that they do any good whatsoever. That is now considered axiomatic. Having assumed that they must be working, you can then write in your conclusions that they ought to be prescribed. Well, think back to your high school geometry class. If you use your axioms to prove your conclusions you are guilty of what? That's right class, circular reasoning.

Remember the study (also in JAMA) that showed that St. John's Wort was no better than placebo? That same study also showed that Zoloft was worse than placebo at alleviating depression, but the authors refused, for no particular reason, to draw that conclusion. How could they? It would have been like claiming that parallel lines meet. It would have violated the axioms of psychiatry.

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.

Democracy's dirty little secret

Actually, it's not a secret at all. Political scientists have been pretty clear about it for most of two decades, and politicians have always understood it intuitively. The vast majority of voters don't have the time, resources, or even for the most part the interest to make a substantial study of public policy issues. The old idea of "rational choice," that people vote based on an weighted inventory of what is in their own self-interest, is defective because it does not adequately consider how people decide what that self-interest is.

Rather than making choices based on logical arguments about how a particular policy will affect them, people use heuristics -- which roughly translates as rules of thumb, or simplified decision rules. Aaron Wildavsky, in 1987, claimed that an understanding of how people develop their political loyalties has to be grounded in theories of culture. He was particularly interested in how people perceive environmental risks such as pollution, but his ideas are more broadly applicable. He was drawn to anthropolgist Mary Douglas's analysis which classifies cultural propensities according to two dimensions, which she calls group and (oddly) "grid."

Group refers to the individualistic-collectivistic continuum: the extent to which people understand themselves as embedded in family and community, and value solidarity and group interest; vs. valuing individual self-interest and self-regulation. "Grid" (a weird, ugly term) refers to the egalitarian-hierarchical continuum: the extent to which people endorse status differences, whether of caste, gender, race, class, social position; vs. favoring equality and disliking privilege.

Note that these dimensions refer to psychological proclivities, not coherent ideological positions. While people will proclaim that they are liberal or (more likely, conservative), few people can explain what these terms mean. An example, from my community organizing days, was the Fishtown factory worker who claimed to be "strongly conservative," and in the next sentence said that we should nationalize the oil companies.

As Wildavsky put it, without knowing much about a proposed policy, people can usually "guess whether its effect is to increase or decrease social distinctions, impose, avoid or reject authority." This model has recently been found to be useful in predicting people's degree of concern about pollution. Surveys consistently find a "white male" effect, in which white men are much less concerned about pollution and other environmental hazards than are non-white men and minority group members of both sexes, and are far more likely to oppose environmental regulation. It turns out, after deeper analysis (much of this work may be credited to Paul Slovic of the University of Oregon and his colleagues), that white males are far more likely than others in the population to score as high grid-high individualism, and it is the subset of white males who do so who are most hostile to environmentalism.

The bad news for them is that regardless of their attitudes about hierarchy and community, they are just as vulnerable to the harmful effects of pollution as everybody else. Of course their exposure liability may be somewhat less, or they may believe it is, because they live in suburban neighborhoods far from factory smokestacks and hazardous waste dumps, although not all of them are so fortunate. But they are in large part mistaken. We all breathe the same atmosphere and depend on the same food supply.

You gotta believe!

There has been some controversy recently about how important the placebo effect really is, and indeed whether it even exists after all. But it seems pretty clear that it does exist, and can be fairly powerful, at least in alleviating depression and pain. As a matter of fact, readers may recall that the much touted randomized controlled trial that supposed showed that St. John's Wort is ineffective against depression also found that placebo was more effective than Zoloft. For some mysterious reason, the latter finding was generally ignored. Hmm.

Anyhow, research reported recently in the British Medical Journal finds that, over a period of several weeks, sham acupuncture (in which a device like one of those stage daggers that retracts into its sheath is used to make people believe they are being stuck with needles), is more effective than a phony pill in relieving arm pain from overuse injuries. Since there is a difference between the effects of the two procedures, there must be a real placebo effect, although we don't have a comparison with no treatment at all, so we don't know exactly how effective it is. I must say, however, that the improvement people in both groups experienced over 8 weeks was substantial.

The real pill to which placebo was compared in this trial was the antidepressant amitriptyline, brand name Elavil, which can have pretty serious side effects, to whit "Anticholinergic effects (e.g. dry mouth, blurred vision, urinary retention, constipation, palpitations, tachycardia, associated sublingual adenitis or gingivitis). Weight loss or gain. Tinnitus, drowsiness, nervousness, insomnia, Hypotension, dizziness, rash sweating, confusion, mania, psychosis, heart block, arrhythmias, extrapyramidal symptoms. Gastric upset. Endocrine effects (e.g. changes in libido, impotence, gynecomastia, galactorrhea). Rarely, bone marrow depression, hepatic toxicity, seizures, peripheral neuropathy, severe cardiovascular effects in patients with cardiac disease, photosensitivity, Dysarthria, stuttering, renal failure. Withdrawal symptoms."

I'll stick with the cornstarch. Take two aspirin if you're really hurting.

The Nanny State?

As our millions of faithful readers know, for better and for worse, I am on crusading public health lawyer John Banzhaf's mailing list. Banzhaf, having wacked the tobacco companies to some good effect, is now taking on the soda mongers. He's definitely right on the science, and I'm with him every step of the way when it comes to restricting marketing and advertsing of harmful products, particularly to children, but we start to part company a bit when we get into the territory of restricting behavior by adults that doesn't directly harm other people.

This came up in the context of his crusade to ban smoking out of doors, essentially on the grounds that it sets a bad example for children. This argument starts to cross the line into thought policing, or at least it triggers the proximity detector. Many people will say that it's up to parents, not the government, to decide what moral influences are appropriate for kids. Here's from Banzhaf's latest:

Several reports about to be published in major scientific journals will
provide very strong additional evidence in massive fat class-action law suits about to be filled [sic] in Massachusetts and other states which will target soft drink bottlers, and potentially involve school boards and individual school board members.

It's already known that one of every five calories in the American diet is liquid, and that the nation's single biggest "food" is soda. The new studies are expected to show for the first time not only that soft drinks are closely associated with obesity, but that they along with other factors are a major cause of obesity. Indeed, the studies suggest that sugary soft drinks may be the leading cause of the current epidemic of obesity.

"Among the many causes of this sudden explosion of obesity and obesity-related diseases -- possibly including genetics, lack of sufficient exercise, fast food outlets, increased portion size, attitude changes, etc. -- soda is probably the one which can be significantly changed most quickly and easily," says public interest law professor John Banzhaf who is leading the battle to use legal action as a weapon
against the problem of obesity.

"That's why law suits and other legal actions directed against sugary soft drinks may be far more effective than expensive public education campaigns -- which have to compete against billions of dollars spent each year advertising soda -- or simply complaining about the lack of personal or parental responsibility."

When the Associated Press suggests in an article that these new studies could lead to "higher taxes on soda, restrictions on how and where it is sold -- maybe even a surgeon general's warning on labels," it's clear that the idea of using legal action to target obesity has become mainstream, suggests Banzhaf.

I go along with his suing soda companies for their "kickbacks for vending machine space" contracts with school boards. Taxes on soda that equal the negative externalities -- the costs to society of obesity and diabetes caused by sugary soft drinks -- are more than defensible under classic economic theory. (Note, however, that the theory supports taxes equal only to the harm to people other than the buyer, assuming the buyer is fully informed and is making a free decision to accept the risk. Such expenses might include loss of support to dependents of people disabled by diabetes, snd costs to the public sector for medical expenses.) A warning label is also fully defensible.

Restrictions on how and where soda is sold, however, are another matter. Although Banzhaf seems to pass it over as a comparatively minor step, in my view it is really the largest, and most questionable one. This represents a restriction on people's liberty to do what they freely choose, that is for willing sellers and willing buyers to engage in a transaction. Assuming the externalities tax and the warning label are in place, there is no evident justification for such a step.

I also am an opponent of prohibition of drugs of abuse, for the most part. (I'm a little shaky on meth.) That subject is a bit more complex, but the same arguments enter into it. Of course, most people who would oppose restrictions on soda sales are probably in favor of the prohibition of heroin and cocaine, and even marijuana, but I'm just thinking for myself here. I believe that much of the public resents what they see as "Nanny State" restrictions on their behavior, such as seat belt and helmet laws, and we need to respect these sentiments. Liberty does count in the balance.

A Paradox of Reason

The hope of early philosophers of The Englightenment was that through reason, we could fully understand the universe and explain all that is. Even today, most laypeople, and for that matter many scientists, are in the habit of thinking that the test of scientific ideas is successful prediction. Positivism, the leading philosophical school of 20th Century science, maintains that the meaning of a statement is equivalent to the means by which it can be verified, in other words that the proof of the pudding is in the eating.

But science has a perplexing secret. Okay, not really a secret, it's out in the open. But it hasn't completely sunk in. It turns out that a good percentage of scientific assertions are not determinist, but probabilistic. Much of scientific explanation is based on what are called stochastic, or random, processes. Indeed, the universe, at the most fundamental level, is now understood to be a realm of chance, of events that cannot be predicted. At the smallest scales, particles and energy flicker in and out of existence in a chaotic foam. Innumerable random events of particular probabilities add up to a larger scale, the scale of our perceptions, which is predictable to a higher degree of probability, but even in our macroscopic realm chance and chaos persist.

Evolution is one field of profound meaning to humans in which stochastic processes rule. Our culture has a deeply ingrained habit of thinking of evolution as a deterministic process, one that tends toward a goal, is governed by purposes and aspirations. Even scientists who work in the field use deterministic and teleological metaphors. (Teleology means the philosophy that there is design or purpose in nature.) Richard Dawkins writes of "selfish" genes. Epidemiologists speak casually of the reproductive "task" and "strategies" of viruses, of viruses "attacking" cells and "using" receptors.

While these metaphors are a convenient shorthand, they are misleading rather than illuminating to the general public. Evolution is governed by chance. Genetic mutation and recombination happen in an essentially random way. (It's a bit more complicated, in that the probability of particular kinds of changes is influenced by genetic repair mechanisms, mechanisms of reassortment and recombination, etc. But they still occur unpredictably.) We think of natural selection as shaping these random events into a definite direction, but that is equally faulty. The "fittest" organism may happen to be unlucky, and leave no progeny. For example, it could be buried under a volcanic eruption, or have the bad luck to be the mouse that was spotted by the hawk even though its camouflage was a bit better than its sibling that was under a log at that moment. We can study the results of evolution, but we cannot predict its future, nor are those results fully explainable. They were certainly not inevitable.

Evolution didn't have to produce us, or sea anemomes, or smallpox. It just happened to. We aren't the culmination of any process or a step on the way to anything else. We just are. The biosphere is complex, fascinating, amazing. But if we were able to start up a second earth and let it run for 4 1/2 billion years, we would wind up with something completely different.

That isn't very satisfying, I know, which is the main reason that most people don't believe it. Get used to it.

A Really Frustrating, Nasty Disease

The New England Journal of Medicine, which you can't read because you're just common rabble, hence no link, has a major review article on current knowledge about Multiple Sclerosis (Frohman, Racke and Raine, NEJM 354(9)), plus an editorial by Allan Ropper about the drug Natalizumab. I read these with considerable interest because someone I care about has MS.

MS is not a disease that gets a lot of interest in the public health community, because we have no idea why people get it, there is no known strategy for prevention, and the only way to treat it is with expensive drugs that don't work very well. However, there are important social dimensions to this disease, as to any other. People with MS often have difficulty with steps, are unable to climb stairs, and may use wheelchairs or scooters. This means that architectural barriers stand in the way of full participation in work, schooling and social and cultural activities for people with MS. My cousin, when she needed accomodations to get to her office, encountered discrimination and hostility from bureaucrats at her workplace.

Although the available treatments can only slow the progression of the disease, they do make a difference, but they are costly. People with MS who are fortunate enough to have good insurance through employment (as my cousin, a lawyer who works in the public sector, does), can receive state of the art treatment, but people who aren't that fortunate have a choice between accepting disability status and poverty in order to qualify for Medicaid, or working to support themselves and not getting any treatment. Not much of a choice, and one more reason to have universal, comprehensive health care that is not linked to employment.

The typical course of MS begins with a relapsing/remitting phase in which people experience episodes of symptoms, and periods of improvement. But after many years, most people enter a progressive phase in which symptoms get steadily worse. The disease process in MS is not completely understood, but it is an autoimmune disease in which the immune system attacks the cells that form an isulating sheath around the nerves, leading to sensory and motor deficits. In the later stages, there also may be brain damage and dementia. Some people, however, have comparatively mild disease and never experience the worst symptoms.

Natalizumab is a so-called monoclonal antibody, a drug that mimics a chemical of the immune system and selectively inhibits the activity of certain immune system cells that are involved in the MS disease process. It reduces the frequency of relapses in people in the relapsing/remitting stage by quite a lot, although it has a less pronounced effect on the development of disability and doesn't appear to do much of anything for people in the secondary progressive phase. Unfortunately, after it was introduced, some people who took it got a disease called Progressive Multifocal Leukoencephalopathy, which is caused by a normally harmless virus that apparently becomes dangerous when the immune system is disrupted by Natalizumab. Further trials have found this problem to be rare, so perhaps we will see Natalizumab reintroduced for more widespread use soon. But it is far from a cure.

So that's it. The only way to really stop this disease is to spend money on high technology biomedical research, and hope the folks in the white lab coats will figure something out. The usual questions about resource allocation apply, but we are talking about an enormous human cost and most people will agree that it's definitely worth it to keep looking, hard, for an answer.

Slacker Thursday

It's not that I can't think of anything to say, it's just that I have too much to say to feel good about frying up a post. So here are a few links to my betters.

We thought we had dispensed with RFK Jr. and the Thimerosal thing, but evidently we're going to have to bury him at the crossroads with a stake through his heart. Orac does the digging and the whittling. NRDC, can you please fire this clown?

I know, I know, you've heard enough gloom and doom stories about global warming, but here's one more in case you figure the opportunity to buy beachfront property in Hartford will make up for everything else.

Philalethes again takes on the weird anti-organic food campaign of Kristin Gerencher.

And whatever you do, don't forget to visit the Museum of Unworkable Devices.

Finally, an e-mail from a concerned reader sums it all up:

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