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Another Open Door Crashed Through

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.

Most health "journalists" base their stories on press releases from researchers, drug companies, and medical device manufacturers. They are caught up in the heroic mythology of medicine, and get all breathless and excited about dramatic breakthroughs and world changing advances. The fact is that medicine advances incrementally, and the vast majority of what happens on the cutting edge offers a little bit of benefit, and a lot of side effects and risks, for a lot of cost. True breakthroughs that offer a big ratio of benefit to risk at reasonable cost don't happen very often, and they generally can be seen only in hindsight, as the result of the accumulation of a lot of pieces of knowledge and technique.

The polio vaccine, which suddenly and cheaply eliminated a great scourge, provided an enduring template for how the culture views medical research. That was more than 50 years ago and I can't think offhand of anything comparable that has happened since then. (Correct me if I'm wrong. Vaccines for measles, mumps and so on are nice, but those diseases didn't compare to polio in their impact.) But reporters are still seeing its ghost.

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  • and one way to beat it. Before I do my usual weekend disappearing act, I do want to encourage all you common rabble out there to read at least one medical journal, and the really great news, as I have pointed out before, is that you can do it for free.

    Public Library of Science Medicine is linked on my sidebar. If you go to the home page this month you'll see a lot of boring looking technical stuff that you might not feel like reading, but do click on through to the current issue and see what's in the table of contents.

  • 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.

  • 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.

  • 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.

  • Long time readers know that I have at times been unkind to Robert Jarvik, inventor of the useless and now forgotten artificial heart, for going on TV and trying to convince you to buy an expensive statin when there are generics available that do precisely the same thing for less than 1/10th of the cost.

    Well, the awesome power of Stayin' Alive is once again revealed as Rep. John Dingell has taken up our cause. I already told you that Jarvik is not a cardiologist and has never practiced medicine, but what I did not know is that he also has never rowed a boat -- that guy sculling across the pristine lake is an impostor. I also didn't know that Pfizer is paying the clown $1.35 million over two years to con you.

  • 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.

  • Via The Prescription Project, this link to a U.S. News and World Report article on the upcoming DSM-V: Who's Behind the Bible of Mental Illness. A taste:

    By Kent Garber

    In what is arguably the most important mental-health development since the early 1990s, the American Psychiatric Association will spend the next five years producing a new edition of the psychiatrist's "bible," the official guidebook for diagnosing mental problems. The Diagnostic and Statistical Manual of Mental Disorders, as it is known, is hugely influential because it determines what is and is not a mental disorder. In turn, it is responsible for much of the sales growth in prescription drugs.

  • 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.)

  • Much of the time, when people are furiously debating some question, it turns out they don't have any substantive disagreement after all -- they are arguing over the meaning of a word. On the other hand, it may not be quite that simple, because the words in question may be embedded in larger constructs, so that disagreements about their meaning can reflect differences in substance after all.

  • 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.

  • 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.

  • 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?

  • 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.

  • We've all heard of "First, do no harm," and we assume this is a fundamental principle of medical ethics. It is not. A physician who truly tried to live by that creed would be out of business. Medical intervention in general almost always carries some risk of harm.

    For example, David Brenner and Eric Hall in the new NEJM remind us that those quick and easy CT scans, even though they make terrific pictures of our insides that doctors really get hot over, expose us to quite a bit of radiation. In fact, they estimate, up to 2% of cancers in the U.S. may be attributable to CT scans. That probably sounds worse than it really is for various reasons that I won't go into here because I'll do it another time, but still, it obviously isn't a good thing.

  • 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.

  • Our good friend Jean, in response to my asking for contributions to President Obama's "to do" list, proposes honest, effective, and comprehensive health education. I think that's an excellent addition. Although I'm afraid it may be too hot to handle for the campaign, it's something we're going to need to address after the dust settles in January.

    If we're going to have honest and effective health education, it has to start with honest and effective biology education. And here, we have a problem. Michael Berkman and colleagues in the May PLoS Biology lay the bad news on us. Sixteen percent of U.S. high school biology teachers admit to believing that "God created human beings in their present form at one time within the last 10,000 years," and 47%, while agreeing that humans developed over millions of years, believe that God guided the process, and one in eight say they teach creationism in a positive light.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

    Massage has been shown to have powerful palliative effects for people with cancer, reducing pain, nausea and other symptoms as much or more than drugs. This project goes one better, by replacing the professional massage therapist with a loved one who also benefits from knowing that she or he can do something effective to help the cancer sufferer. That feeling of helplessness is one of the hardest things about facing a serious illness in a loved one, of course. And the relationship between the two also benefits. We hope to demonstrate these benefits using the gold standard methods of biomedical research. (I take no credit for developing the program, we're just helping our colleague with the trial.)

  • 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.

  • If there’s one, key distinguishing factor between big companies and small ones, it’s the amount of time, effort and attention the large companies dedicate to market research. Market research, as most companies view it, can be an expensive undertaking even when managed by the most proficient of facilitators. In the wrong hands, the combined costs of lost opportunities, incorrect conclusions drawn

  • 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.

  • 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.

  • Now that I have been chewing on the vast amount of information that was fed into my brain during my stay in Austin, there is one thing that has been a constant whisper in the back of my mind. It comes from a conversation that I had with a woman from another agency.

    As I think we all realize, advertising is changing. Well actually, the world is changing and advertising is caught in the ripple effect. Technology has opened another world where there are unlimited possibilities for the marketing of products. We, as people who work in advertising, have to open our minds, think differently, and try to explore all the amazing ways to utilize this new space. It is intimidating, daunting, and for some of us, incredibly exciting.

  • 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.

  • So, now that we've cleared away the technical underbrush -- and I hope you'll forgive what may have been a self-indulgence, but I just love biology, for sheer wonder and amazement it beats the hell out of theology -- let's follow Prof. Korobkin as he parses the ethical issues, and add our own two cents -- or maybe two bucks.

    The people who believe -- quite fervently in most cases -- that a single zygote, or a 16-cell blastocyst, is a "human life," and that destroying it is murder, obviously don't base that claim on any discernible resemblance between the object in question and what we normally think of as a human being. In fact, they don't generally try to justify it at all, they just proclaim it, but when forced to explain their reasoning, the usual response is that it represents the potential for human life, and that's close enough to being human life to deserve the same respect. (Note that they cannot base their claim on scripture, which makes no mention of abortion, nor for that matter can they blame it on Christian tradition as the Christian proscription of abortion is in fact a modern innovation.)

  • 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: