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Rough day

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.

On the other hand, it isn't quite accurate to view access to trials as a benefit to the individual patient. The principal of "equipoise" means that in order for a trial to be ethical, we really have to not know whether the experimental treatment is better or safer -- or worse or less safe -- than the standard treatment. The only time access to trials is really a benefit is when people are terminally ill and standard treatments have failed; then, you might as well go ahead and try something. This is the situation in so-called Phase II trials, which are small and intended mostly just to establish a basic level of safety and some evidence of efficacy, to justify a larger scale Phase III trial.

Anyway, the issue gets to the root of major problems in our health care and biomedical research infrastructure: lack of minority investigators, lack of minority health care providers, and failure to involve affected communities at all stages, from setting research goals, to selecting therapeutic targets, to planning trials, to recruiting participants. We need a new paradigm of community based participatory research, to make the enterprise equitable and democratic. But you've probably gotten tired of hearing that sort of thing from me.

Anyhow, now I have to read student papers - and grade them, which I really dislike doing. So hasta mañana.

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  • 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.

  • 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.

  • Let me take a break from blowing vapor about the bio-psycho-social conception of health and make it real for a bit. We're collaborating with a researcher who I won't name just yet because I didn't ask permission on a project which is really terrific. It's a randomized controlled trial of a program to teach therapeutic massage to caregivers -- spouses, siblings, children, friends, whatever -- of people with cancer. There is an orientation, and a DVD, and a manual, which don't just teach techniques but put massage into the context of loving relationships and the emotional and spiritual (deity free) consequences of serious illness.

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  • It seems the bad news Senator Kennedy got this week has caused a lot of focus on cancer in general. Before I add to that particular chatter, let me say a word or two about Ted Kennedy. I worked for Ralph Nader just after I graduated from college, and back then Kennedy was already a force in the Senate. He was also already overweight, in perpetual need of a haircut, and not exactly abstemious, and he stayed that way until just a few years ago. In 1994, when Mitt Romney ran against him for reelection and it looked like it might be close, a friend of mine said, "Well, I voted for the bloated, alcoholic murderer, and I'm sure glad I did." Yes, he didn't always display the greatest maturity, self discipline or courage in his personal life, but he knew that his privileges and his sinecure in the Senate were not earned, and that they conferred an obligation to everyone less fortunate, and particularly the most vulnerable. He spent his life as a drum major for justice.

  • 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.

  • C. Corax is curious about my response to this study which suggests there may be a genetic component to religiosity. Unfortunately, I don't have on-line access to the Journal of Personality so I can only comment on this reporter's summary. Nevertheless, this is a good opportunity to make some general observations about, uh, observational studies in general, and twin studies in particular.

  • 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.

  • Item One: It is my duty to comment on the study published last week in NEJM that came up with a new estimate of civilian deaths in Iraq following the 2003 invasion. The consensus spin on this was "See, those peaceniks got all hysterical over the earlier estimate of 600,000, it was only 150,000." So I guess the war was a good idea after all. Actually neither study is conclusive. The new one was based on a larger sample, which all things being equal is better, but it was conducted later, which is worse. The basic problem is that households in which people have died are less likely to be around to be sampled, and the problem gets worse as time goes on. This happens for a few reasons -- some households get wiped out entirely, and then there is no-one left to sample. Households that have lost the breadwinner are likely to dissolve, to move in with relatives, to leave the country entirely -- as 2 million Iraqis have done.

  • Here's a cross post to a entry I just put up on the Freakonomics blog.

    Randomized trials are the gold standard of medical testing, but so far no one has come up with a single example of a team that has used a randomized control trial to test alternative sports strategies.

    I hereby offer a free copy of Super Crunchers to the first person who points to the first published randomized study of strategy. (I might even send one to first person who can convince me that one has been done even if it hasn't been published).

    I'd be happy to help a coach of virtually any sport at any level help design and run a randomized test of alternative strategies.

  • 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.)

  • Here was Part 1.

    I'm surprised by what I'm discovering about the possible carcinogenic effects of meat. I'm also surprised that these points weren't raised in any of the literature I read so far surrounding low-carb diets, which almost universally promote meat consumption. I've been experimenting with low-carb diets as a way to manage my blood sugar. But with the recent diagnoses of cancer in my family, I'm revisiting their safety.

  • A couple of weeks back, Jack invited me to guest blog about my new book, Stem Cell Century: Law and Policy for a Breakthrough Technology, just out from Yale University Press. The book examines a broad range of legal and policy issues raised by stem cell research, starting with the issues that garner significant media attention, such as President Bush’s restrictive federal funding policy, but going substantially beyond to consider issues concerning cloning research, the patenting of stem cells, innovation policy as related to stem cells, issues of research subject protection and tissue donor compensation, and questions of regulation by the FDA and the tort system.

  • And no free pass for President Obama either. As you know if you've been reading -- because I mentioned it a few days ago -- Obama's health care proposals include requiring insurers to cover preventive services, which he claims will reduce health care costs. Hillary Clinton makes some vaguer claims along the same lines, to the effect that universal coverage will end up saving money because people will get timely preventive care.

    Joshua Cohen and colleagues in NEJM consider this proposition. (And you'll be pleased to know that this is one of those articles of broad public interest that the editors have made available to the rabble, so go ahead and read it.)

    Alas, as a general proposition it isn't so. Screening and prevention may be worthwhile, but that isn't the same as saving money. Very few procedures actually produce a net cost saving. Cohen et al don't point it out, because it isn't really the focus of their analysis, but the really bad news is that extending people's lives actually costs money. If somebody drops dead of a heart attack, you only have to pay for the funeral. But if they live for 20 years taking beta blockers and ACE inhibitors and statins and getting angioplasties etc., you've prevented a heart attack, but spent a helluva lot of money.

  • 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.

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  • I haven't written much about the whole embryonic stem cell thing, partly because I never saw it as the most pressing issue. The media and the public are obssessed with the possibilities for dramatic, high technology biomedical breakthroughs, but what we're really talking about are procedures that in a decade or two might benefit a small number of people in wealthy countries who have uncommon injuries or degenerative diseases associated with advanced age. The vast majority of the earth's people will never be able to afford these treatments, and they already are lacking in far more basic needs. Even in the wealthy countries, as a matter of fact, we can accomplish far more public health benefit for far less money with simple measures that we don't bother with. So while I have thought that restricting stem cell research on putative moral grounds is absurd, and the opposite of moral, I have had more important things to worry about.

  • 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.

  • My thanks to the commenters on my post about my father -- and thank you particularly for sharing some of your own stories. I try to let my personal life intrude minimally here, but as a disciple of the late Irving Kenneth Zola I take very much to heart his insistence that sociology can only be called objective when we disclose ourselves. It may seem paradoxical but only if you haven't thought about it very hard. Obviously, I have a personal stake in the issues I write about here. You should only conisder me credible to the extent I reveal it.

  • 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.

  • Sorry to have missed a couple of days -- I've had a bit of a cold, nothing major but it's left me at a low energy level and I've had to devote what I had to other projects. In the coming week, I'll be away from Your Intertubes quite a bit as well so I may post only on a couple of days.

  • 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.

  • Some diagnoses of cancer have hit my family in the last few months. It's been a trying time. I've been especially keen to understand why, so I've been pouring over research. One dietary item keeps popping up ... meat. I don't know what it is about meat ... heme-iron, hormones, a type of fat, environmental toxins that are dissolved in animal fat, carcinogens produced via cooking, etc. But the association is common in my reading.

  • Monday morning I continue my jet setting lifestyle by flying off to DC for the Joint Meeting on Adolescent Treatment Effectiveness. That refers to substance abuse treatment.

    Now, like a lot of you, the way I remember my adolescence the biggest drug problem we had was insufficient supply. However, the problem we have today is entirely different. There is a major epidemic of adolescent opioid addiction in the U.S. right now, including 16 and 18 year old kids who inject heroin. When I was a youth the idea of going anywhere near heroin was absolutely appalling. I never knew anyone who would even consider it. Ditto with meth. Yes, people got into that stuff but usually not so young, and it was largely limited to poor communities. Scholars of addiction could honestly say that the problem was not drugs, but lack of life prospects, or psychological damage. People with jobs to go to and education to pursue could get high on weekends but they would show up on Monday because they had a reason to, and they did not become addicted.

  • Gary Schwitzer in PLoS Medicine:

    • The daily delivery of news stories about new treatments, tests, products, and procedures may have a profound—and perhaps harmful—impact on health care consumers.
    • A US Web site project, HealthNewsReview.org (http://HealthNewsReview.org/), modeled after similar efforts in Australia and Canada, evaluates and grades health news coverage, notifying journalists of their grades.
    • After almost two years and 500 stories, the project has found that journalists usually fail to discuss costs, the quality of the evidence, the existence of alternative options, and the absolute magnitude of potential benefits and harms.

  • Woohoo it is Friday, which means that after today my big work project will be completed and I can finally rest again. Writing major grants is always a major stressor. I usually want to pull my hair out by the roots at some point in the process. It doesn’t help when I have people needing things from me at the same time I am trying to complete a grant. This weekend I need to finish Bel Canto and start on the Color Purple. I had planned to finish Bel Canto on the plane Tuesday night but there was screaming babies and toddlers on my plane that made it difficult to concentrate.

    In the News:

  • 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:

  • A Promise of Hope / Autumn Stringam
    Toronto : HarperCollins Canada, 2007.

  • I sure am glad it's not my job to come up with the best eating plan for all Americans, let alone the world.1 (The World Health Organization has my sympathy.) The choices and defenders of those choices are numerous and polarized.

    Regarding carbohydrates, it may be that a low-carbohydrate diet, around 10% of calories, is the best eating plan for overall health for everyone. Alternatively, it may be that a high-carbohydrate diet, above 45% of calories, is. Research has not sufficiently compared and contrasted the two.

  • Jeffrey K. Tulis

    Whether Senator Obama has a well worked out domestic policy agenda and a detailed understanding of foreign policy is a lingering concern of democrats who find his inspirational rhetoric short on specific analyses, proposals, and plans. This concern has provided occasion for Senator Clinton and others to revive Walter Mondale’s famous question to Gary Hart, taken from a then popular TV commercial for a hamburger, “where’s the beef?” Obama may be tempted respond to the question by offering detailed counter-proposals to Senator Clinton’s plans for health care, immigration, the economy, campaign finance and any other issue she chooses to highlight. This would be a mistake both as tactical choice in the primaries, and in light of his impressive understanding of the place of the presidency in the constitutional order.

  • This morning we heard from Dr. Kelly Kelleher about how it's a great idea for primary care doctors to screen for alcohol and other drug abuse problems. There are, however, some difficulties.

    Every disease advocacy organization in the world wants primary care doctors to be screening -- for asthma, diabetes risk, cancer, depression, domestic violence, you name it. In fact there are something like 700 questions that primary care docs are supposed to be asking their patients. However, they generally see 4 or 5 patients an hour. Since the patients are presumably there for some reason other than to be asked the first 30 or so of 700 questions, it's unlikely we're going to get very far with that.

  • 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.