Suppose you knew you had a terminal illness, and the doctor told you there was a drug that cost almost $100,000 a year, that had not been shown to help people with your condition live any longer; had potentially serious side effects; and might even kill you itself. However, it did seem to slow the progression of signs of your disease such as the appearance of x-rays. Would you take it? As a taxpayer or a payer of insurance premiums, would you want the government or your insurance company to use your money to pay for it?

The FDA says yes, and yes. Avastin, a so-called angiogenesis inhibitor, was just approved for use in metastatic breast cancer, even though all of the above applies, and the relevant advisory council had voted against approval. Avastin has been shown to slow the growth of tumors, but not to confer any significant survival advantage. Again, the FDA has approved a drug on the basis of a so-called "surrogate" end point, some element of a disease process or a presumed risk factor that it affects, without any evidence that the drug actually benefits patients in any subjectively meaningful way.

They got some pretty little women there and .. .

Oh, never mind. Anyway, my jet setting lifestyle continues as I will be in Jersey City Sunday through Wednesday for the Third International Conference on Antiretroviral Adherence. Sounds a little narrow, I know, but the subject actually is quite revealing as a test case for physician-patient relationships and communication and disease management and stuff in general.

Conference presentations aren't as strictly and paranoically embargoed as journal articles, so I will tell you that in general terms, my colleagues and I have found that if you give doctors a report about their patients' medication taking behavior, they will indeed talk about it more during the visit -- twice as much, on average, in fact. However, that does not result in the patients being more adherent to their medication regimens.

In fact, it has the opposite effect.

As I have said before, I'm not going to be all over the health care proposals of the presidential candidates because whatever they are saying now is not miraculously going to become reality after January 20. It's all going to get processed through the Congressional/K Street/Moronic Corporate Media meat grinder anyway, and who knows what vile offal might emerge?

But, the debate last night has no doubt raised questions in people's minds regarding what that was all about with the mandates and the amputations and what not. Let me say, first of all, that the debate as a whole was extremely heartening. It was largely substantive, we've got two capable candidates who both demonstrated a willingness to submerge their competing personal ambitions for the good of the nation, and it would be absolutely shocking if one of them doesn't become president. Whoever it is will spend the next few years shoveling out a shitpile that makes the Augean stables seem like your cat took a dump on the rug, but maybe they'll get something done on health care.

So, you can go to the respective web sites and read it all for yourselves, but here's my executive summary.

Readers are begging for more about the Massachusetts health care reform legislation. Okay, not begging, but they have expressed mild interest. You can get a one page overview here, and the authority responsible for administering the law, called (weirdly) The Connector, provides links to the actual legislation and associated regulations here.

Unfortunately, in my view, this legislation has become the model for the leading Democratic national proposals. To answer Kathy A.'s question, the law provides sliding scale subsidies for low and moderate income people to purchase insurance. To answer Roger's question, it provides for fairly stiff fines for individuals who don't get insurance, although less than the cost of actually buying it.

I'm not going to give much in the way of references or concrete history in this post -- it's basically for conceptual background. But, just pulling it out of an orifice, the story goes something like this.

Until around about the 1960s -- by which I really mean the early 1970s, since the 60s lasted from about 1965 through 1974 -- there was very little questioning of the medical enterprise from within -- or from without, for that matter. Or at least there hadn't been for a long time, since the critical ferment surrounding the Flexner Report in 1910. Back then, the criticism was essentially that medicine was largely unscientific, but in the 1960s, the problem turned out to be just the converse -- that medicine had become too narrowly biological, in the process becoming patriarchal, inhumane, and even contrary to the interests of patients.

But they do try to predict health care costs ten years out. You may have seen a news brief about the new prediction that health care spending will be 19.5% of GDP by 2017. Health Affairs has made this open access, so go for it if you are turned on by wonkery.

Now, there are a lot of assumptions that go into any such prediction, and it's pretty obvious that unless the McCain campaign succeeds in its increasingly transparent plan to make voters believe that Barack Obama is a secret muslim extremist who has been planted by al Qaeda to turn the country over to Islamofascist infiltrators and give Tomahawk cruise missiles to Hamas,* some of those assumptions will be overturned somehow some way, and they probably won't all work out anyway. But, for what it's worth, the broad outlines of what these perpetrators of deep wonkery expect assuming that nothing major changes are as follows.

I was as confused as hell today when I first read this in the New York Times, then I checked out this week's NEJM and read this (abstract only for you uncredentialed scum).

Item One:

For decades, researchers believed that if people with diabetes lowered their blood sugar to normal levels, they would no longer be at high risk of dying from heart disease. But a major federal study of more than 10,000 middle-aged and older people with Type 2 diabetes has found that lowering blood sugar actually increased their risk of death, researchers reported Wednesday. . . .

Among the study participants who were randomly assigned to get their blood sugar levels to nearly normal, there were 54 more deaths than in the group whose levels were less rigidly controlled. The patients were in the study for an average of four years when investigators called a halt to the intensive blood sugar lowering and put all of them on the less intense regimen.

Item Two:

The Randomized Controlled Trial (RCT) is the so-called gold standard for determining what is and is not evidenced based therapy. When we talk about the clinical trials submitted to the FDA in new drug applications, that's what we're talking about. When people call for Evidence Based Medicine, they mostly want doctors to use interventions that have been "proven" through RCTs.

So it was refreshing to day to hear Malcolm Gordon, who is an official of the Center for Mental Health Services, tell us about many of the reasons why RCTs don't necessarily tell us what does and does not work when it comes to mental health services. For example, they are very expensive to do, so they seldom go on long enough or have large enough sample sizes to support adequate subgroup analysis. An intervention that works for some people might not work for others, but we just don't get the information we need from RCTs to understand that. Attrition is a big problem in trials, particularly of mental health treatments, and it can seriously mess up the statistics. A truly major problem is that interventions are developed, implemented and tested in highly specialized settings and circumstances that just don't correspond to anything that is likely to happen in the real world of the mental health system.

The CDC has asked a colleague of mine to participate in a consultative group on HIV prevention for Latinos, and she asked me to contribute my thoughts on the four big questions they are asking. My pleasure, I do happen to have some opinions.

Based on your knowledge of HIV/AIDS among Hispanics in the United States;

1. Identify at least two community and two societal-level factors that place Hispanics/Latinos at disproportionate risk for acquiring HIV. How should CDC
address these factors?

Much of the disproportionate risk for HIV among Latinos in the northeast is related to injection drug use. While primary prevention is certainly what we would most want to achieve, unfortunately the evidence base for primary prevention is limited. (See below.) We do know that treatment can be effective, and furthermore, as IDU must be transmitted from users to non-users, treatment of current users does constitute a form of primary prevention as well. (Think of it as analagous to infectious disease control. Current users are infectious; get them into recovery, and you stop transmission.)

Talk about polarizing issues. While campaigning in South Carolina yesterday, presidential candidate Fred Thompson said:"I don’t think that it’s the primary responsibility of the federal government to tell you what to eat."Thompson: Don't Let The Government Tell You What To Eat

This was unbelievable. To see this kind of frankness in a public report just made my jaw drop. Virtually all of the diabetes- and health-related material I've laid my hands on over the years has skirted these issues. Most of those publications, however, were either produced by drug companies directly, or indirectly influenced by them. My non-profit is.

Continuing with the question "What is health?", let's consider the mind-body problem.

The ancients viewed the mind and body as a single entity. Hippocrates could write with equal authority about diseases we would today differentiate as physical or mental. "Hysteria," for example, was caused by movement of hte uterus, and depression by imbalance of the humors.

Modern positivist philosophy, often traced back to Descartes, has famously split mind and body. From Descartes' time until very recently, if at all, the inner workings of the mind have not been readily susceptible to empirical investigation by the standards of positivist science. (Maybe functional Magnetic Resonance Imaging is changing that -- we'll see.)

A couple of recent reports in the popular press on academic exercises offer considerable food for thought. First, I'll offer my own well-fed cogitations on this effort by a task force of physicians in various powerful positions to decide who gets triaged to the scrap heap in the event of an influenza pandemic or a comparable mass casualty event. Unfortunately, the issue of Chest in which this report appears hasn't made it onto my library's on-line subscription service yet, so I can only go by the news report. Hence I don't know the full composition of the task force. It includes representation from the military and the Department for the Impregnable Defense of the Glorious FatherlandHomeland Security, among other federal agencies, as well as medical societies and prominent academic physicians. I'm sure many will see this as vaguely sinister but I'll give them the benefit of the doubt as to motive.

Yesterday I noted the report in the new JAMA on Merck writing research reports about Vioxx and paying prominent academics to pretend to be the authors and investigators. That got a fair amount of coverage in the corporate media. Today I finally had a chance to read this piece by Bruce Psaty and Richard Kronmal, also free to the public. I thought I'd seen it all. I hadn't.

Maybe the reason this hasn't gotten a lot of coverage is because reporters find it slightly harder to understand; or maybe they're just too chickenshit to actually write down what this article says because they're afraid Merck will threaten to sue them or something. So sue me.

What this article says is that Merck murdered people. Here's the story in a nutshell. They wanted to prove that rofecoxib (Vioxx) could delay the onset of Alzheimer's disease or slow its progress. I don't know why they thought it might do that, but whatever, they tried it. So first they did a trial of almost 1,500 elderly people with mild cognitive impairment, half of whom got rofecoxib. It turned out that the people who got the drug had a significantly higher probability of developing Alzheimer's disease.

I claim no psychic powers. I've been telling y'all for years now that antidepressants basically don't work. The drug companies have been promoting the fiction that depression is a specific disease of the brain caused by a "chemical imbalance," specifically a deficiency of the neurotransimtter serotonin, which their potions -- Prozac, Zoloft, etc. -- purportedly cure. It's all nothing but a big pile of crap.

Irving Kirsch and colleagues, in PLOS Medicine, tell us what shakes out when you look at all the RCTs that have been done on these "medications," including the ones the drug companies made sure not to publish. Naturally, the ones they didn't publish are the ones that show their products in the worst light.

There's been plenty of coverage of the results of the so-called ENHANCE study that casts doubt on the effectiveness of Vytorin in preventing atherosclerosis, but very little of it, as far as I can tell, casts much light on the public health policy issues behind this latest debacle. (Vytorin is a combination of a statin, the traditional cholesterol-lowering agents, and ezetimibe, a chemical that blocks absorption of cholesterol from food.) In fact, the stories tend to appear in the business section, where the emphasis is on what's going to happen to Schering-Plough stock. Here are a few things the corporate media isn't telling you.

First of all, if you have watched television for even one hour in the past year, you have probably failed to escape the advertisements for Vytorin, one of the drugs most heavily marketed to consumers in all history. Those are the ads with people dressed up to look like food, and the line that "There are two sources of cholesterol: the food you eat, and that produced by your body based on family history." You are urged to take Vytorin because it addresses both of these sources.

I haven't ranted very much lately about the democratization of science, and mea culpa. So the theme for today is that we can't have a more democratic scientific institution if most people lack the basic knowledge they need to participate.

This is the story of my professional life, actually. My day job is with a community based public health agency, and my academic half is concerned with people's control -- or usually lack thereof -- over their own health and health care. (As I often say, I am a community-academic partnership.) My work concerns all sorts of issues -- mental health, addiction, environmental justice, diabetes, heart disease, you name it -- but HIV is a particularly big piece of it, in part because it has paradigmatic qualities that make it particularly instructive for many of the principal concerns of medical sociology.

No doubt you've heard the news that nearly half of physicians surveyed say they have known about impaired colleagues but have not reported them. The principal investigator finds this absolutely astonishing, but what astonishes me is that he finds it astonishing. Everybody who hangs around the profession knows this -- not only do doctors not report impaired colleagues, they give positive recommendations when incompetent physicians seek work elsewhere. What surprises me is that only 45% will admit to this, when the true figure is probably much closer to 100%.

Like you, I really don't have a clue what exactly TF Hillary Clinton thinks she's been doing for the past couple of months, or why she's been doing whatever it is, but in any event, no matter what she says tonight, starting right now Barack Obama and the Democratic Party -- with the possible exception of Hillary and 182 fervent supporters who will continue to hold out in caves on some remote Pacific islands -- will start to run against John McCain for the office of prezneh unigh stay, as Sen. McCain pronounces it. That means that if we are very lucky, we just might hvae some conversations about public policy.

So here's my list of public health priorities. It's difficult to put them in order, and I might change my mind five minutes from now, but as of 1:42 pm eastern time they are:

It turns out that Heath Ledger's death is what we in the biz call an iatrogenic event, i.e. "caused by healing." [sic] He had taken a lethal combination of oxycodone, hydrocodone, diazepam, temazepam, alprazolam, and doxylamine. Now, I have no reason to believe his death was not an accident, but if you wanted to kill yourself, that would be a good way to go.

He had prescriptions for two opioids, three benzos -- two of which are marketed as tranquilizers, and one as a sleeping pill, but they're similar -- and an antihistamine that makes you drowsy as what used to be a side effect, but is now the reason it is prescribed. He had apparently complained of difficulty sleeping, but I don't know why he had the scrips for the junk and the tranks. What I do know is that you sure as hell aren't supposed to take them all at the same time, for reasons which should now be obvious.

Digby, (who has turned off commenting apparently because it bugs her when people figuratively yell at each other by hurling photons down fiber optic cables) gives this account of the battle for California's Democratic voters -- Obama reaching past the cerebral cortex to forge a mystic connection with the lizard brain, Clinton's generals meticulously marshalling the troops. Note that in neither case is the election about public policy.

And of course it cannot be. Elections are about very expensive theater, as edited and repackaged by a corporate media with its own bizarre obssessions that have no discernible relationship to any definition of the national interest or the interests of any definable group within society except for their own self adoring selves; and as transmitted directly by the campaigns to the extent they can pay for advertising. Secondarily, once sufficient brains have been rewired by the dramaturgy, the zombies have to be marched to the polls, which is where the military-style organization comes in.

All of this costs immense amounts of money, so that's where it all begins. And that's our form of government -- a moneyocracy.

I'm not a clinician, I'm here as a project evaluator with the intention of getting sense of the what the field of mental health care for traumatized children is like these days -- at least for those community based agencies and academic experts who are fortunate enough to have support from SAMHSA as part of the National Child Traumatic Stress Network.

There's plenty of good news here -- then I'll give you the bad news.

Good news bulletin #1: I have heard scarcely a word about psych meds. The only way pills have come up is as a peripheral note that somebody who is part of a case scenario had been prescribed something. The NCTSN is not about drugging kids.

Bulletin #2: The DSM-IV is equally conspicuous by its absence. There is absolutely no interest in classifying kids' problems as diseases, tossing around disease categories, or using diagnostic labels to guide treatment.

Nobody close to my family reads this blog -- hell, my mother doesn't know your Intertubes from the Pony Express -- so I feel okay about posting this here. It's private, but it's nothing to be ashamed of anyway.

My father has advanced frontotemporal dementia. It happens to be of the variety called primary progressive aphasia, not that it matters. It isn't the same as Alzheimer's disease but it ends up in the same place, for all practical purposes. He is in a nursing home. He has long been incontinent of urine and feces, has been unable to carry on a meaningful conversation for a long time, and is now unable to speak, does not appear to recognize my mother, barely responds to stimuli, is essentially unable to walk, and recently he became unable to feed himself, so they have to spoon feed him. There is some concern that he has difficulty swallowing.

Barbara Burke in the new JAMA reviews Bipolar Children: Cutting Edge Controversy, Insights, and Research, Edited by Sharna Olfman. Unfortunately, it's subscription only, but I'll give you a fair-use quote:

IN EUROPE AND ACROSS THE GLOBE, MANIC DEPRESSION IS rarely diagnosed in the pediatric population. In the United States, on the other hand, the American Academy of Child and Adolescent Psychiatry (AACAP) suggests that it may exist in up to 13% of children.1 Prescriptions of sedating drugs (anticonvulsants, -agonists, and atypical antipsychotics) have increased up to 3-fold in the last decade.2 Both of these anomalous trends, poorly substantiated by quality research, have occurred during a time of dramatic economic change in the health care industry. Meanwhile, US children appear to be getting less mentally healthy, not more, with diagnoses of “mood disorders” and “pediatric bipolar” (PBD) topping the list. This is clearly crazy, but where does the madness lie? In the children, the prescribers, or society as a whole?

This is a depressing story, no matter how you look at it. The government calls it a mystery.

Study: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial
Population: 10,251 patients with type 2 diabetes at high risk for heart disease

About half of those folks were assigned to an intensive BG treatment arm, the other half to a standard treatment arm.

Intensive Treatment Goal: HbA1C < 6.0%, fasting BG 100 mg/dl or less, 2-hour postprandial BG 140 mg/dl or less
Standard Treatment Goal: HbA1C of 7.0 to 7.9%, fasting BG of 90 mg/dl or more, postprandials not used

After about 4 years (range: 2 to 7 years), there were 254 deaths in the intensive treatment arm and 203 deaths in the standard treatment arm ... a difference of 54 deaths ... a difference which went in the wrong direction.

So okay, I could wallow around in wishy-washy sophomoric philosophy for a few more days, but let's put the key issue on the table. What do we mean by good health? Sure, that's technically just a semantic question, but it's actually substantive because the word "health" tends to stand in for whatever the ultimate goal is supposed to be of the blob that ate the economy -- or at least one of the blobs, the Department of Imperial Hegemony Defense being the other.

While Freud got psychiatrists out of the lunatic asylum and into cushy offices, nevertheless his work only increased the influence of dualism in psychiatric practice and the relationship between psychiatry and the rest of medicine. While the theory of "functional disorders" did forge a link between mind and body, the etiology of the disorders lay in psychodynamic processes, the still ethereal stuff of mind. A psychiatric diagnosis depends on ruling out "organic illness," and vice versa.

In the 1930s, psychiatrists tried to further advance their prestige within the medical profession by creating the field of psychosomatic medicine. In the functional disorders, patients experience physical symptoms but no organic referent for those symptoms can be found. Psychosomatic illnesses, in contrast, are "real" in that organic symptoms are observable.

No time today to continue my project of Thinking Deep Thoughts, it will return tomorrow. I spent most of the day at a symposium on access to cancer clinical trials for minorities, where I facilitated a workshop. An interesting subject though a bit more complex, in my view, than many of the other participants see it. African Americans, Latinos, Native Americans are all grossly underrepresented in clinical trials of cancer treatments. That should not be.