I realize there is a lot of potential for confusion when we talk about the drug approval process and exactly how consumer protection and drug company economic interests interact. I'm not actually a major expert on these issues myself but I think I can at least give you a handle on some basic concepts that will help clarify matters.
First, drug manufacturers, like every enterprise engaged in research and development, can file for patents on new compounds. These generally last for 20 years. As long as a company holds a patent on a compound, no other company can sell it, unless they come to an agreement with the patent holder and (ordinarily) pay royalties.
However, you can't legally sell a drug and make health claims for it without FDA approval -- called a drug license. (Not to be confused with a license sold by a patent holder to another company to make the drug.) Before getting a license to market a drug, a company first gets an investigational license that allows them to test it in clinical trials. By the time this process is completed and a company is licensed to market a drug, much (if not all) of the 20 years of patent protection has expired. So Congress has sweetened the incentive to develop new drugs by also allowing the FDA to grant additional marketing exclusivity periods, typically of 5 years.
If a drug is licensed, then physicians can prescribe it (or it can be sold over the counter if it has that kind of license). However, the drug companies are additionally restricted by the FDA in the specific claims they can make when they market the drug. That won't necessarily stop doctors for prescribing it "off label," for unapproved indications, but the companies are not legally allowed to encourage them to do so. This is a major problem area. Enforcement has been lax, and drug companies have found all sorts of ways of getting around these restrictions.
Once both the patent and marketing exclusivity periods have expired, other companies can apply to manufacture the drug. But they have to satisfy the FDA that their formulations are biologically equivalent to the original. The original license holders can intervene and contest these claims.
Once generic versions of a drug are available, the price typically goes way down, because now there is competition. The unit cost of manufacturing a pharmaceutical is usually trivial. Drugs are expensive because of marketing exclusivity which allows manufacturers to charge whatever they think they can get.
The final layer in this casserole is insurance reimbursement policy. Medicare is pretty much required to pay for drugs prescribed for any approved indication, but private insurers can set their own policies and they often have tiered co-payment systems that encourage use of medications which are cheaper for them. They can also refuse to pay for certain treatments if they choose. This is an endless source of confusion to physicians who have to deal with patients whose insurers use different "formularies," or lists of approved drugs at various levels of copays.
Drug manufacturers try to extend their marketing exclusivity by coming up with just slightly different versions of old drugs that they hope they can persuade consumers and physicians are better and hence worth paying brand name prices for. This is called "evergreening." The whole COX-2 inhibitor fiasco can be understood as essentially an effort to evergreen aspirin. They can also keep advertising the brand name drug and hope to persuade people it is better than the generic, viz. Lipitor. (There is absolutely no reason that I can see for anyone to pay for Lipitor with very cheap generics available that are biologically equivalent. But remember, I'm not a real doctor.)
Here's some information about all this on the FDA's web site.
So, to clarify a recent flapdoodle, the FDA had given conditional approval to market Avastin for metastatic breast cancer on condition the manufacturer conduct additional trials to demonstrate that it really works. It turns out it doesn't, so approval for those specific claims has been withdrawn. However, Avastin is still licensed and approved for other indications, so doctors can still prescribe it to women with metastatic breast cancer if they want to. The question is whether insurers will pay for it. Presumably, once the appeal period is over, and if it is unsuccessful, Medicare will not.
That's why Genentech is unhappy. But it's a) still licensed and b) still under marketing exclusivity.
Then there's the whole question of so-called "supplements," which we'll get to another time. . .
Monday, December 20, 2010
A brief primer on drug regulation wonkery
Friday, December 17, 2010
They'll keep spouting this nonsense . . .
Reporting by NYT's Andrew Pollack:.
The F.D.A.’s decision also drew political criticism, with some Republicans contending that withdrawing this treatment for breast cancer was akin to rationing under the new health care law.
“It is troubling that women in Germany and France will soon have access to a life-saving drug, while women in the U.S. will not,” Representative Kay Granger, a Texas Republican, said in a separate statement.
When will the corporate media, and the people, catch on that these people don't actually believe a single word they say. They don't give a moldy fig about the federal deficit, wasteful spending, or for that matter Medicare or your health. They only care about their corporate masters. This is not a life saving drug, that's the whole point. It is, however, a money making drug for Genentech. That's the only thing that matters to Kay Granger.
First Principles
Apologies. I missed yesterday because my life was just too hectic. Right now I'm living in two different places and working (mostly) in a third, gradually disentangling myself from one home and trying to get established in another, finding my way in a new work environment and taking on new projects, and commuting more than 1 hour every day, which I have never done before and don't care to continue. Meanwhile, just getting the normal stuff done -- from auto maintenance to doctor appointments (yeah, I get doctored) to shopping -- is complicated and requires advance planning about where I am going to be and how I am going to get there. Add to that several recent Mondays in Baltimore and it's very draining.
I'm not complaining, not at all. All this is in service of an opportunity I chose to accept, and it will all get sorted out and settle down in due course. But it leads me to reflect a bit on what health really means and how it is produced. We have some conventional measures of population health which are awfully crude -- infant mortality rate, life expectancy.
We can look at age adjusted rates of specific illnesses, if they happen to be available for a given society, although these are generally very much distorted by what we call ascertainment bias. You don't have diabetes unless you've been diagnosed. So one population might have a higher rate of diabetes than another because the people are more likely to have insulin resistance and hyperglyecmia; or because they are more likely to have doctors who do tests and end up telling them that they have diabetes.
The simplest thing to do is ask people how healthy they think they are. The simple question, "Compared to other people your own age, would you say your health is excellent, very good, good, fair or poor" is actually strongly predictive of life expectancy among older people. But why do people answer as they do?
Many people do not take pills their physicians prescribe, even inexpensive ones with few or no discernible side effects, even though the doctor has told them, and they may well believe, that they're likely to live longer if they take them. Maybe it's just not worth the hassle, or they'd rather spend the $15 a month copay on something else, or life is better if you just don't worry about too much stuff.
One of the strongest determinants of population health, as conventionally measured, is social inequality. Egalitarian societies are healthier, even if the average level of wealth is lower, within a pretty wide range of total affluence. And, up to a point, richer people also say they are happier, on average -- although plenty of not so rich people also claim to be happy and lots of rich people aren't.
My affluence is slightly above average, and I don't have any diagnoses of major diseases. I have a bit of osteoarthritis as most of us do as we grow older, but it really doesn't stop me from doing anything except maybe running marathons. My life is satisfying in some respects but not others. What's missing is actually important, but it can't be fixed by doctors.
I am really unhappy, though, because of what I see happening around me. I'm in a reasonably good position to weather the storms ahead but most people are not and we may well be headed for very unpleasant times. This disturbs me greatly. So am I healthy? I could go to a psychiatrist or psychotherapist and discuss my angst. I don't think I would get a disease label but you never know. In any case, what would be the best investment in my health and that of the people around me? Should it focus on the services of physicians and the goods they purvey? If not, what should be a higher priority use? If we spend less on medicine, what should we spend more on?
Those are probably more important questions than the ones I usually discuss here.
Wednesday, December 15, 2010
The Truth is Out There
I've been re-reading The Bias of Science by Brian Martin, published in 1979, which figured in my master's thesis. (Which, by the way, was titled Which Way is Up? Social Welfare and the Ideology of Progress.) I find that some of Martin's monograph holds up okay, some of it not so well. But it strikes me that overall, there's been a fairly radical reversal in the zeitgeist in just 30 years.
Martin builds a political and social critique of the scientific enterprise around a dispute which is nearly forgotten: whether it was wise to operate a large fleet of supersonic transports (SSTs). Proposals for SSTs were promoted in the 1970s in the U.S., Britain, France and the Soviet Union. They were controversial mostly on environmental grounds -- opponents were worried about sonic booms (unquestionably real) and the possibility that emissions of oxides of nitrogen from jet engines in the stratosphere would deplete the earth's protective ozone shield. Martin closely analyzes two scientific papers, one supporting the danger of ozone depletion and the other minimizing it, and finds them both tendentious in various ways.
One key point of Martin's critique is that a debate framed almost entirely as environmental directed attention away from economic issues. It scarcely seemed remarkable at the time that a large public investment was needed for the SST even to be possible, and it is interesting that he doesn't even seem to notice this. It would surely be noticed today. But regardless of where the money was coming from, did it make sense to put what would in today's terms be many of billions of dollars of R&D and production costs into a means for rich people to save a couple of hours on a transatlantic flight?
As it turns out, the economic question took care of itself. In the end, only 20 Concordes were every built and they were retired in 2003 because there weren't enough rich people willing to do that after all. The U.S. program never happened, and the Soviet program was a failure that never operated commercially.
I hope to discuss Martin's work in some detail eventually, but for now I want to notice One Big Thing. Back in the ancient world of the 1970s, there was a substantial critical movement both within and outside of science that viewed the scientific enterprise as largely a creature of corporate and elite power. This was partly based from within a broad acceptance of the philosophy of science, but attentive to the selection of scientific problems, and the way in which findings were promoted, suppressed, and interpreted to serve privileged interests. It was also partly based in more radical "post modernist" critiques which contended in essence that all interpretations of reality are at least to some degree arbitrary and which even seemed to deny the existence of objective reality. Martin mostly wants to be in the first place, but he at least sets foot in the second.
Nowadays, however, there is something wrong with this picture. Nobody can claim that science, on balance, is a tool of corporate interests, when the corporate party in the United States is an implacable enemy of a large swath of scientific understanding. Corporate power never managed to recruit more than a small minority of scientists, mostly people whose careers had failed to develop within mainstream scientific institutions, to its well-funded campaigns to deny the health effects of tobacco, or lead pollution; the environmental effects of acid rain, mercury, and fine particle pollution; or more currently, anthropogenic global climate change.
To be sure, the corporate media were seduced by these campaigns for a while, and still are by global climate change denialism, but ultimately the scientific consensus won out in the earlier cases, as it surely will in the latest. We have seen that in an important applied area of science, evaluation of new drugs and medical devices, corporations have succeeded in suppressing findings unfavorable to their products and manipulating and cherry picking data that favor them. But it turns out that there was enough countervailing pressure from university and even government experts that they are finding this more and more difficult to do. (It doesn't hurt that they keep getting successfully sued either.)
It turns out that for all that it proceeds by fits and starts, goes down blind alleys and stumbles over falsities, over time science does converge on ineluctable truths. The world really is a certain way, it really does make certain kinds of sense, and if you keep hacking away at it you will find that out. It is what it is. And if that happens to be uncongenial to the Koch brothers, all of their billions cannot change it.
Tuesday, December 14, 2010
Unlike Glenn Beck and Sarah Palin . . .
I'm not a scholar of constitutional law. However, I can have an opinion about the practical, common sense implications of policies. The "individual mandate" to purchase health insurance has been the main focus of lawsuits by teabagging state attorneys general claiming that the Patient Protection and Affordable Care Act is unconstitutional. Now that the co-owner of a right wing consulting firm that made money in the past year by opposing the act, who also happens to be a federal judge (who would have thought that was permitted?) has ruled the individual mandate violates the constitution, there is much rejoicing to starboard. Most experts think the ruling is insupportable, and several judges have already dismissed similar lawsuits, but given the makeup of the Supreme Court, we would be very unwise to depend on what most lawyers understand to be the law.
That said, the only reason we have the individual mandate, instead of tax funded insurance, is because of the prevailing ideology. The difference is essentially semantic -- we have all sorts of federally required individual mandates. For example, I am required to pay for pieces of missiles and agribusiness profits. If I were required to mail checks to Raytheon and Dole, it might feel more offensive, but except for the price of the stamps it would pretty much amount to the same thing.
So we got the individual mandate, which requires us to mail checks to Aetna and WellPoint, because that seemed less "socialistic" than single payer national health care. The wingnuts don't like it anyway, so they're suing. But there would be absolutely no constitutional question whatsoever about raising taxes to pay for health care, which after all the federal government already does, just not universally.
The individual mandate is a much worse alternative for all of us, because a chunk of our money goes to the socially useless, parasitic insurance industry; it is much more difficult to create a properly progressive financing regime; and it is much more difficult to promote efficient and effective use of resources and stop the relentless suctioning of our national wealth into the pockets of drug companies, medical device makers, and overpaid medical specialists, among others.
I don't know about you but personally, I'm not giving up. With a Democratic House and Senate in 2013, we can fix this mess very easily by introducing a public option. Between now and November of 2012, we need to keep working to reframe the terms of this debate and purge the bullshit.
It can be done.
Monday, December 13, 2010
The slipperiness of truth
For much of the 20th Century, as scientific discovery and technological innovation were the dominant drivers of social change and major intellectual preoccupations, the generally accepted philosophy of science was positivism. I'm not going to go into any detail on that here (but you can read some of my past discussion here and in the links therein embedded). I just want to make a simple point: the central idea of the verifiability of scientific assertions runs into trouble when you get to probabilistic statements -- which, as it turns out, probably most scientific assertions happen to be.
Scientific inquiry relies heavily on statistics, notably so in epidemiological and clinical research. But think about it. When the weatherbot on your local teevee says "There is a 50% chance of rain tomorrow," how do you decide whether that assertion is true? Whether or not it rains tomorrow is no help, obviously.
Even if you follow the weather forecasts and the actual weather for a long time, you can't quite tell at what point you start to believe that the forecasters are making accurate predictions. If it rains 52% of the time they say there's a 50% chance, they haven't been exactly right but maybe that's just bad luck and it will even out the next few times.
The squishiness of probability creates a big fat opening for bias -- unconscious or deliberate -- in the presentation of clinical trial data. For the story I am about to summarize I rely heavily on Melanie Newman in the Dec. 11 BMJ, which sadly I cannot link to as it is behind the subscription wall, but here are the first few paragraphs.
The key question is a debate over the circumstances under which published research should be officially "retracted," which means in essence that the journal declares the paper no longer to exist as peer reviewed science, and it centers on a single paper published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry, reporting a clinical trial sponsored by the company which is today Glaxo Smith-Kline of its anti-depressant paroxetine. The paper claimed the drug was effective for treating depression in adolescents.
The problem is that based on the 8 outcomes specified in advance, it was not more effective than placebo. These included 2 so-called "primary outcomes," which were the change in the average score on a questionnaire called the Hamilton Rating Scale, and the proportion of subjects who met a threshold for improvement after 8 weeks. So what did the investigators do?
They cooked up 19 new secondary outcomes, and found a positive response on four of them, one of which they then proclaimed, ex post facto, to be "primary." The manuscript was actually drafted by a company contractor, after an internal memo declared that it would be "commercially unacceptable to include a statement that efficacy had not been demonstrated."
Although all this is now publicly known, the journal refuses to retract the article because they claim it does not include any false results. Whether this assertion is itself true is essentially imponderable. Yes, all the numbers shown in the tables are accurate, and so are the p values based on the calculations that were actually done. But to say that the p values are accurate is to fundamentally misunderstand the concept of statistical significance.
It is supposed to represent the probability that an observed difference could have arisen purely by chance, without representing a real association in the total population. But that only works if I make a single comparison (assuming I don't have any information about prior probability -- which gets us to Bayes theorem, which is really where we always ought to begin anyway, instead of with p values. But I digress.) If I make 21 comparisons, as in this case, chances are I'll hit on some ostensibly "significant" p values (which is an arbitrary standard to begin with) purely by chance. The values aren't really significant after all.
So the numbers in the paper may be true in some sense; but the conclusions are false. Their meaning has been fundamentally misrepresented. I don't know if that means the paper should be retracted, however -- if we start going down that road we're going to have a massive bonfire.
Friday, December 10, 2010
Mission Accepted
You may have seen a link to this posting by M.S. on The Economist blog, which has drawn some blogospheric attention. Only 6% of scientists identify themselves as Republicans, compared to 55% who identify as Democrats. M.S. wonders why:
I can think of three testable hypotheses they might look into. The first is that scientists are hostile towards Republicans, which scares young Republicans away from careers in science. The second is that Republicans are hostile towards science, and don't want to go into careers in science. The third is that young people who go into the sciences tend to end up becoming Democrats, due to factors inherent in the practice of science or to peer-group identification with other scientists. In the absence of data, I leave it to you to decide which you find most plausible. But by all means, social scientists should look into this.
Hey, I'm a social scientist! But I don't have to look into it, I already know the answer, and it's None of the Above.
Scientists study reality, carefully applying rigorous methods of data collection and rules of inference. They think from evidence to conclusions. I don't need to tell you that reality has a well-known liberal bias. That's why conservatives don't go near it. They reason from a priori principles to decide that reality must be whatever they need it to be in order to believe what they already believe, which isn't actually true. So they can't be scientists.
Thursday, December 09, 2010
Reap This Righteous Rant
Michael Millenson, on the Health Affairs blog, opens a can of whoop ass on the medical industry for apathy about patient safety. Since the much ballyhooed Institute of Medicine Study To Err is Human, issued in 1999, we have made essentially no progress on reducing the estimated million preventable patient injuries, and close to 100,000 deaths, in hospitals every year. (People don't even seem to think about outpatient iatrogenic injuries and deaths. I'll get to that in due course.)
Millenson's basic point is, we know how to enormously improve safety and reduce errors that harm patients, but people just don't bother to do it. Hospitals eschew opportunities to join programs to enhance safety, because their administrators think they're already just so fabulous, or they are worried that by trying to do better it will look like they are admitting they have a problem, or . ..
They actually make money by harming patients. That's right: when people suffer avoidable complications, such as catheter associated infections, the hospital gets paid more to take care of them. Of course if the patient dies they might earn less due to the shortened stay, but that's usually a risk worth taking. Millenson doesn't mention that Medicare is trying to change reimbursement policy to eliminate this perverse incentive in certain readily definable and obvious cases, but in general, it's still true. (It was true in my own case, BTW, when surgeons erroneously removed my ascending colon and then fed me while my bowels were still paralyzed, and oh yeah I got nosocomial C. difficile. Then they sent me a bill for $25,000. I told them to fold it until it had as many corners as humanly achievable entonces metelo donde el sol no brilla. But they tried. But I digress.)
The way to fix this, of course, is the way civilized countries fix it: put hospitals on a global budget to take care of the population of their catchment area. Everybody gets a salary, and nobody makes a profit, but people can get bonuses for doing good stuff. That way, the incentives are to deliver care as efficiently and effectively as possible. And oh yeah, they have to meet the standards of the single payer, whether they like it or not.
But no, that would be socialism. So don't even think about it. Just shut up and die.
Wednesday, December 08, 2010
Anecdotal evidence
I can't answer Daniel's question about what percentage of medical spending in the U.S. is for stuff that we just shouldn't do in the first place, but this story in Health Affairs illustrates the problem. A 90 year old man with dementia, heart disease, and diabetes, goes through hospitalization, surgery, multiple tests that cause serious complications, in and out of a rehabilitation facility, all of it costing more than $200,000, and none of it doing him a damn bit of good. He dies six weeks later.
There isn't any corruption, and not even any significant misaligned financial incentives behind this debacle. It's largely a function of our medical culture -- shared by physicians and the public, in this case as represented by the patient's daughter -- which just assumes that doing more is better and leaving well enough alone is irresponsible. And oh yeah, that we must never just accept death.
Listen up buster. Death is unconquerable, at least as of 2010. So is getting older. Get used to it.
Tuesday, December 07, 2010
Cheap, completely understood, and it works
That would be aspirin. I wrote about it a long time ago, the message being that drug companies invested a lot of money in (as it turns out bogus) research and marketing in order "evergreen" aspirin. Since the patent on aspirin was gone before I was born, it sells for bupkis and anybody can make it. Ergo, Pfizer and Merck couldn't make any money off of it. Hence we got the debacle with the Cox 2 inhibitors, which were supposed to do all the good of aspiring with less risk of gastrointestinal side effects.
Sadly, no, as it turns out, because aspirin reduces the risk of heart disease and ischemic strokes, whereas the Cox 2 inhibitors increase it. I'd rather have an upset, or even bleeding stomach (generally reversible if you just stop taking the aspirin) than drop dead. And I have always felt that the side effects were overblown as a result of the drug companies hyping them in order to justify their much more expensive products. I'm not a real doctor, so don't rely on that judgment -- and for sure, not everybody can take aspirin. But at low doses, it's unlikely to cause problems.
There's no money to be made from aspirin, so it's hard to fund studies. As you may have heard, these docs in the land of the brolly and bowler hat did a secondary analysis of data from trials originally intended to determine the cardiac benefits of aspirin. Turns out it is also fairly effective at preventing many cancers. Not dramatically -- about a 20% reduction in risk of death from cancer over 20 years, and only if you keep at it for all that time. 75 mg a day will do it, more is not better!
Yes, there can be side effects but it's one more thumb on the scale in favor of more people considering this. (As always, ask your doctor, and I don't mean Dr. Ruth.) By the way, although salicylic acid is famous for being found in willow bark, it and similar compounds are found in many vegetables, which may help account for the overall goodness you get from eating lots of them. Just a speculation on my part, but it looks good.
The real lesson here is that aspirin was a miracle drug 100 years ago, but we haven't studied it nearly enough because there was no money to be made from it. If the drug companies had invested in understanding more about aspirin, instead of trying desperately to find something patentable, we would have gotten this news a long time ago. But of course they never will, because the Free Market™ doesn't allocate sufficient resources to basic research that can benefit humanity. Only government can do that, because knowledge is a public good.
Monday, December 06, 2010
It's Ecomomics 101 time again . . .
From the NY Times, a disgusting story about a cardiologist who was implanting stents, by the hundreds and thousands, in people for whom they were not indicated. As you may recall, these devices don't actually reduce your risk of heart attack or death. At best, they relieve the chest pains which can be a symptom of cardiovascular disease. In our last episode, we learned that many patients who receive them have the impression that they do in fact reduce the risk of heart attacks and extend lives. Did they just misunderstand their doctors?
Or did their doctors lie to them? From the Times article:
Edward Chaid, 68, a semiretired general contractor from Timonium, Md., is among those who have sued. Five years ago, Mr. Chaid decided to get his first physical examination in decades. Just to be safe, his doctor sent him for a cardiac stress test at MidAtlantic, which revealed a small “squiggle” of concern, Mr. Chaid said. He was sent to Dr. Midei to get his arteries X-rayed, and he emerged from the procedure with two stents.
“Dr. Midei said: ‘You sure are lucky. You had 90 percent blockage.’ And the nurse said, ‘Oh yeah, you were blocked in your widow-maker.’ And I said: ‘Thank God. I guess I’m really lucky you got it when you did,’ ” Mr. Chaid said in an interview.
Actually Mr. Chaid didn't even have a severe blockage, but even if he had, if he didn't have chest pain, there would be no reason to implant the stent.
I'll leave it to interested persons to read the Times article for all the gory details of this story, which also involve Abbot Labs and the hospital as unindicted co-conspirators. But for our purposes the point of this story is that once again, it proves that neoliberal economics is completely disconnected from reality.
Libertarians and their allies in the
The problem, obviously, is that you and I don't have the slightest idea whether we would benefit by more than $10,000 from a stent. Let's even leave aside the issue of third-party payment. If somebody told me I needed it to save my life, I'd come up with the ten grand somehow on my own, if I possibly could. How was I supposed to know the guy was a greedy psychopath who was lying to me so he could pocket the fee?
This is obviously an extreme case. The medical industry could not function at all if physicians didn't have a code and a culture of ethics that we know we can rely on. We have to trust our doctors and most of the time, they are basically trustworthy. Still, if there is money to be made, they are likely to be swayed unconsciously in the direction of doing more. And the culture of their specialty will, again without conscious bias or awareness of pecuniary motives, tend to lean toward valuing what they do highly. No surprise, if you are diagnosed with prostate cancer, surgeons will think you need surgery, radiologists will think you need radiation, and oncologists will think you need chemotherapy; but maybe what you really need is nothing.
This is why it is ridiculous for conservatives to try to scare us with the specter of government bureaucrats coming between us and our doctors. We and our doctors need the best possible information about what treatments are indicated and cost effective under what circumstances, and they need some guidelines to keep everybody at least in the ballpark of doing the right thing. Without that, we don't just waste money, we get physically assaulted and maybe seriously harmed, if we happen to stumble on an amoral greedhead. Free Markets™ and liberty have nothing to do with it.
Sunday, December 05, 2010
A doctor of the wrong philosophy
Benjamin R. Barber, Walt Whitman Professor Emeritus at Rutgers, writes in the November 29 Nation (subscription only) on "America's Knowledge Deficit." He hits the spot with me on his main point, that an "epistemological deficit . . . is putting Democracy at risk." He writes that
[F]ar too many Americans, including not just many of the new Tea Party politicians but established leaders like former president George W. Bush, honestly think the difference between, say, evolution and creationism is merely a matter of opinion: you think man is descended from apes; I think he is a creature made by God. Tolerance, to Bush, means we respect both views and acknowledge their common creditability, because, after all, we both feel deeply about the matter -- which means, in turn,we teach both views in our schools.
Well yes, except that man [sic] is not descended from apes. Prof. Barber needs to brush up on his evolutionary biology. Humans and apes have a common ancestor, which was not quite ape and not quite human. It is most accurate, probably, to say that we are apes. But this is a common misconception, which I will forgive.
However, Barber goes more seriously wrong:
There are, of course, many issues that cannot be judged by empirical evidence or objective truth. The existence of God is one of them. These are normative rather than empirical claims. . . . When as an evolutionist I claim man is descended from apes . . .I am claiming something that can be corroborated or falsified by reference to fossil records, genetic affinities, geology and other kinds of empirical data and testable hypotheses. When I claim God created man and then woman from the rib of man, there is no way to confirm or falsify this claim, no "evidence" that can counter what is subjective belief.
Err, no. The claim that God made "woman from the rib of man" is as false, and as falsifiable, as the claim that "man" is descended from apes. Religious beliefs about the nature of reality and the history of the world are completely falsifiable, and almost always false, because they derive from faulty epistemology. Barber has adopted the unfortunate attitude of many people who want to adopt the stance of reason but don't want to offend religious people by pointing out that there beliefs are, quite obviously, false. For some reason we just can't say that, so we need to put them in a separate category where "truth" means something different than it does in, well, reality.
This is just silly. God did not make a woman from the rib of a man, there wasn't any Noah's ark, and Jesus was not born of a virgin and did not walk around accosting people after he was dead. These assertions are objectively false and can be disproved by resort to our senses and reason, just like every other objectively false assertion. And believing in falsehood is bad for you.
Site news: I have indeed established a new blog, called Windham County. There isn't much there yet, but I'll be posting material there that doesn't really belong here, to keep Stayin' Alive clean and on topic, at least somewhat. Let me know if people want to exchange links. (The Dharma Bums get a freebie.)
Friday, December 03, 2010
Stuff
This is more of a personal note than I usually write here, but I want people to know what's going on with me. As I have at least hinted, I'm in the process of gradually moving out of my home of more than 20 years, taking stuff one pickup truckload at a time to my country place in Connecticut. As soon as I can sell the property in Boston, I'll get a pied a terre of some kind near my new workplace in Providence. It's obviously done with mixed feelings. My underlying reluctance is making it go more slowly than it needs to.
But there's also something healthy about it. I'm finding out what I have -- a lot of old junk and paper that has existed in my space for years or decades for no particular reason, it turns out. I'm throwing away more than I expected, although it's often a close call. On the other hand, it's just as often the case that I have no idea why I kept something in the first place. For some reason, I had several newspapers and magazines from what, as far as I can tell, were unremarkable days in 1999. A lot will be recycled but a lot will also go to the landfill. At least it's mostly non-toxic, except maybe for all the toner cartridges from an old photo printer that doesn't work any more. (And how the hell do you ethically dispose of electronic equipment, anyway?)
But I'm also discovering things I'd forgotten about, that are worth keeping, and that also remind me of past thoughts, plans, ideas -- some of which, who knows, might be reborn one day. I'm keeping some material that's just autobiographical evidence -- reminders of past events, people I knew, observations of the day.
Anyway, I'll end up not only traveling through life a little bit lighter, at least until the accumulation returns to its present level; and also a little more in touch with myself, a little bit better organized, and if I don't lose momentum, a lot tidier. Still, it's kind of sad.
Thursday, December 02, 2010
It's Economics 101! (The Continuing Series)
Government regulation stifles economic growth and innovation. Lift the dead weight of government from the backs of our entrepreneurial class and we'll all be more prosperous and free. And oh yeah -- I'm actually Brad Pitt.
Commissioner Margaret Hamburg reviews the history of the FDA in the new NEJM, which, quaking before the mighty power of Stayin' Alive, makes her essay available to you, the undoctorated. As Hamburg tells us, before the FDA came along, heroin was marketed as a remedy for coughs and asthma. It does actually work, unlike most of the crap that was sold as medicine in those days.
At first though, the FDA couldn't require proof of safety before medications were marketed. In 1937, a company sold sulfanilamide (an antibiotic) in a solution of diethylene glycol, otherwise known as antifreeze, which as you probably know is not good for you. In fact it killed more than 100 people. So Congress passed the Food, Drug and Cosmetic Act to require prior evidence of safety. The FDCA, by the way, spared the United States from the Thalidomide disaster which resulted in thousands of babies born with severe birth defects in Europe.
It wasn't until 1962, however, that the FDA could require good evidence of effectiveness before approving drugs and approving marketing claims. One third of drugs then in common use ended up being withdrawn from the market because they just didn't work.
It was regulation that spurred the immense explosion of pharmaceutical innovation since that time. Only when they were required to develop good scientific evidence of safety and effectiveness did drug companies actually start spending the money to get it -- big investments that have had big payoffs for human health.
We still have a long way to go -- publication bias, me too drugs, and aggressive marketing of drugs that are no better or even worse than their cheaper competitors still plague us. We need better, stronger regulation. But it's the regulation we do have that has spurred scientific knowledge, technological development, and the wealth generated by the pharmaceutical industry. Without it, we'd still be swallowing snake oil.
BTW, the specific flaw in the totally bogus theory of the Free Market™ in this case is the requirement of perfect information. Consumers don't have information about whether drugs are safe and effective unless the government requires it. That's why we need government intervention in the market to give us drugs that help, rather than hurt us. There's no other way.
Wednesday, December 01, 2010
Minority Report
I've just gotten done participating in a proposal review process. I'm not allowed to say anything specific about it, and I know that specificity is the essence of good story telling, so this will just have to be a badly told tale. Still.
I really didn't like the proposal, but everybody else did. The basic reason was that I couldn't see any good reason to do undertake the experiments the investigators proposed, whereas the other reviewers do the same sort of thing themselves so naturally they weren't very open to the idea that it's all basically pointless.
To get slightly more specific, this has to do with the existence of some new high tech toys that allow people to make observations that sound like they ought to be really cool and might even be like really wild cool stuff that you read about in science fiction -- to be even more specific, reading people's minds.
That's about as specific as I can get but here's the bottom line. We know that stimuli get registered in the brain, and that the brain creates experience, such as specifically pain. So if people are in pain certain parts of the brain are more active, and if they are in less pain those places are less active. On the other hand we don't know what pieces of that, if any, have to do with the conscious experience of pain, because most of what goes on in our brains does not impinge on our consciousness. And just looking at the pictures will never, ever tell us. And for that matter, even if it could, what would it mean other than, these are the part of the brain that are active when we are in pain, and these are the parts that are associated with our conscious experience of pain. If I do something that results in people reporting less pain, I would expect the images of their brains to be like the images of brains of people who report less pain. So what?
Apparently so something, even though they couldn't really explain it to me. So this will probably get funded. Oh well.
Good science isn't about fancy toys and stuff that only a few people know about. It starts with asking the right questions. And that's not just a matter for scientists -- it ought to be a right of the people.
Tuesday, November 30, 2010
Bo-o-o-o-o-o-o-o-o-gus!
People who ought to know better are apparently unaware of the basic laws of inference. Here's a headline: Study: Drugs Linked to 1 in 5 Fatal Car Crashes. "Of the 21,798 drivers were killed on the road in the United States in 2009, about 18 percent of them had drugs in their system at the time of death, the National Highway Traffic Safety Administration says in a new report released Tuesday."
"Drugs" includes illicit and legally prescribed drugs and over-the-counter medicines.
What question did they fail to ask? (Jeopardy! music plays . . . )
What percentage of all drivers has one or more of these drugs in their system at any given time? Could it be as high as 18%? Wouldn't surprise me one bit.
Where was I?
Sorry for the no post yesterday, I had to get up at the crack of dawn to fly to Baltimore for a three hour meeting, and fly back that afternoon. Yeah yeah, bloggers who do that sort of thing usually blog from the airport but I just wasn't up for it. Apologies for the carbon emissions as well but it wasn't up to me.
Anyway, I don't subscribe or regularly read The Economist, but it is a good way to kill 3 hours so I often buy it at the airport. As I presume most readers know, this is a British magazine which is not particularly written by or for economists. It's a comprehensive review of global affairs, somewhat comparable to Time or Newsweek but far smarter and more comprehensive. It is generally considered conservative in outlook and I suppose it is, by UK standards, but by current U.S. standards it's not that far from the Daily Worker. It could be the Bernie Sanders campaign manual. That's how warped we have become.
Here's their latest page on the U.S., where they endorse the Fed's "quantitative easing" while pointing out that it's an inferior option which is only necessary because we have provided insufficient fiscal stimulus; endorse not only the DREAM act but comprehensive immigration reform while slapping Republican demagoguery about "amnesty"; and also slap the Republicans around over blocking ratification of the new START treaty, among other positions.
Every issue has a theme section and this week, it was anthropogenic global warming, which they portray as an urgent problem which we ought to be addressing by reducing carbon emissions but, since that apparently isn't going to happen, they focus on possible responses.
The Economist is also entirely free of the pervasive American trait of narcissism -- it opens up to the world and tries to free itself of a British centered perspective. Its dispatches from darn near everywhere -- Sri Lanka to Kenya to Brazil as well as the more obvious major powers and hot spots -- take the local perspective and dispassionately portray local culture and politics.
If we had conservatives like that, we would not be idiots. But we don't, and we are.
Saturday, November 27, 2010
A speciation event?
Now that I'm a part-time country boy fer sher, it's a major new experience for me and I'm going to be tempted to write a lot about my observations of the nature of nature and the idiocy or wisdom of rural life and all that. For example, today I spent the morning in my neighbor's woods harvesting firewood from the tops where he had a lot cleared and some sustainable logging done. Heating with wood is normal here, and chainsaws in the distance are background music this time of year.
Wood cut in the fall is no good till next winter, but it will be perfect then, and this is a good time to cut it. The understory has died so it's easier to see what's going on and make your way in the woods, and the leaves are off the trees so it's easier to clean up your fire logs. Loggers, in fact, prefer to work in the winter, even with snow on the ground. This time of year, it's not so cold that I didn't sweat a bit working hard, but it does feel cold when you stop. With the sun so low, it feels like it's late in the day, all day.
So, firewood forces you to be very forward looking, storing up not for this winter, but for next. Rural forms of Self-sufficiency in general tend to be like that, very obviously. What I do this fall will have a lot to do with what I can produce from the garden next summer, and from fruit trees in three or four years. I suppose that's true of any career or business one tries to build, but in these particular matters the link between current effort and future prosperity holds little mystery.
Anyway, what I'm thinking of doing is starting a new blog, to be called Windham County, where I can post all this sort of idiocy, and keep Stayin' Alive more or less on topic. Not that I'm always great about that but I'd like to keep it within limits. Let me know if you have any thoughts.
Thursday, November 25, 2010
Ah-ooooooooo!
Now that I'm spending more time in the country I'm getting to know where I live. Last night as I was drifting off to sleep a coyote got to whooping and hollering, seemingly just outside my window. It gave a complicated performance consisting of rhythmic yelps and howls that broke upward in the middle by a diminished fifth. (The Devil's interval, banned by the medieval church.) The concert lasted two or three minutes, with the pattern of yelps and howls varying throughout. Later, after midnight, presumably a different individual, or at least it was a different song, somewhat farther away, gave a brief, simple performance consisting of four howls with slight downward inflection.
They apparently do this to tell other males to stay out of their territory, and invite the females in if they are so inclined. (When I try it it doesn't seem to work.) But for a predator to announce its presence so assertively seems awfully sporting. As I say, the turkeys can fly up into the trees.
Wednesday, November 24, 2010
It's Economics 101!
Yet again. One very common conservative trope is that making people pay out of pocket for their health care will make them wise consumers and help control health care costs. This is not a finding, of course, it's an assumption, and it's an assumption based on a prior assumption that consumers have perfect information and behave "rationally" -- both of which are essential to the theory of the Free Market™.
Here is a very simple illustration of why this isn't true. When Blue Cross Blue Shield of North Carolina eliminated co-pays for generic medications, more people took their calcium channel blockers and other basic maintenance meds. These are very inexpensive medications that really do prevent strokes, heart attacks, and kidney failure, which are very expensive when they do happen.
A) People don't make a cost-benefit analysis that that tells them paying the 5 bucks for the pills is worth it, especially if they need the 5 bucks for something else; and
B) Even if they did know how to do the calculation, they might just say what the heck, I'll take the chance, it isn't really going to happen to me.
And for that matter, sometimes people don't have 5 bucks. But we still have to pay for their dialysis.
While we're on the subject, what's in that tea they're drinking anyway? The whole thing is supposed to be about cutting government spending, but the last thing in the world they will ever stand for is -- cutting government spending, specifically in this case spending on Medicare. The Patient Protection and Affordable Care Act created the Patient Centered Outcomes Research Institute, which will fund comparative effectiveness research, but the language specifically states that the institute "shall not develop or employ a dollars-per-quality- adjusted life year (or similar measure ...) as a threshold to establish what kind of health care is cost effective or recommended under Medicare." So we aren't allowed to save money because that would be "rationing." We have to cut spending, cut taxes, cut the deficit, and commit ourselves to infinite spending on Medicare. But we also can't guarantee health care for people under 65.
Makes perfect sense.
I am now headed for Windham County, which is positively infested with turkeys -- real ones, the kind the pilgrims ate, not the grotesque freaks farmers have bred with gigantic breasts and microscopic brains. Real turkeys can fly, quite well. And they're smart enough to thrive and multiply despite the harsh New England winters, and the foxes, coyotes and bob cats. If Ben Franklin had gotten his wish, and the turkey, rather than the eagle, had become our national symbol, would we be less inclined to go to war?
Tuesday, November 23, 2010
A slightly tough question
I guess. At least it seems to be to a lot of people. For reasons I cannot disclose, I've been thinking a bit lately about the placebo effect -- or possibly effects. Due to some combination of expecting to get better, and therapeutic attention, people who get treatments that have no specific biological effect tend to report that they feel better than people who get no treatment. This only works, obviously, with symptoms. There is a strong response to placebos in depression, and many people also respond who have chronic pain.
Now, this is philosophically a bit tricky to begin with. Pain and depression are more or less defined as particular ways that people feel. There could be "objectively" measurable correlates, such as range of motion in the case of pain or appetite in the case of depression, but if people say they feel better, then it seems pretty ridiculous to say the treatment wasn't really effective. Feeling better is what they want.
Accordingly, Brian Berman and colleagues raised quite a few hackles back in July when they argued in NEJM that physicians ought to refer people with idiopathic chronic low back pain (CLBP) to acupuncturists. CLBP is a real pain in the backside because most of the time, it doesn't correspond to any identifiable physical cause and it doesn't respond well to analgesics, physical therapy, or anything else. Surgeons used to do spinal fusion all the time, until it was shown that the surgery was actually a placebo. People responded just as well to fake surgery, in which they were opened and closed but nothing else was done, as they did to the real surgery.*
It turns out that people with CLBP also respond to acupuncture, even though it is well established that acupuncture is actually bogus. It doesn't matter where you insert the needles, or even whether you insert them at all. As long as people think they've had acupuncture, they often report feeling better. The same is true of homeopathy. Homeopathic 'remedies' are completely useless, but homeopathic consultations make people feel better.
So should doctors give people fake pills, or fake physical interventions such as pretending to stick needles in them? It only works, remember, if you tell the people that it will make them feel better. Actually, that's true, but it's only true because you're saying it. In other words, you're fooling them, sort of, but as long as they are fooled, it's not fooling . . . And this sentence is a lie.
Okay, here's what I think. There is no need to pay money to fake therapists for fake treatments. We can instead have real doctors who are engaged, empathetic, take time with their patients, and give them whatever treatments they can that have been shown to be more effective than placebo, along with encouragement and sound advice about coping. As Edzard Ernst writes (in the essay whose abstract is linked above):
Modern mainstream medicine seems to neglect the importance of medical core values such as empathy, sympathy, time, understanding and holism. This creates a situation where alternative practitioners tend to provide the non-specific and mainstream doctors the specific effects. Clearly this is wrong and may be one reason why patients consult alternative practitioners.
*Yes, this resulted in the famous defunding of the Agency for Health Care Policy and Research at the behest of spinal surgeons who cared more about money than they did about their patients.
Monday, November 22, 2010
Excavating my past
I don't recall whether I have mentioned it in this space, but I'm getting ready to move from my home in Boston, where I have lived for more than 20 years. I haven't sold the place yet, but I've started going through the mass quantities of paper and junk, moving what I can to my country place and deciding on what to landfill.
It turns out I have a lot of stuff I didn't know I had, and I did quite a few somewhat consequential things I hadn't thought about for a long time and had nearly forgotten. Back when I was in graduate school, for example, I paid for my crusts of bread with a consulting business. Among the projects I took on were a minority needs assessment study for the city of Fitchburg, Massachusetts; and strategic planning processes, including environmental assessments, for Boston Mobilization for Survival and Boston's Multicultural AIDS Coalition.
I found my files from these projects in a box in a spare bedroom I've been using for storage. This all happened in the early 1990s, and obviously there is no practical need to keep the papers. I ended up tossing them. But it got me to thinking about history. It consists of stories built around whatever evidence happens to have survived.
Ethnic relations in the post-industrial Merrimack Valley in the 1990s would be an interesting subject for a history dissertation. Fitchburg is a lot like Lawrence, where the famous Bread and Roses strike happened in 1912. It's a mill town where back then, immigrant workers were from Eastern and Central Europe, Ireland and French Canada. In 1994, those were the "indigenous" residents and the town was painfully absorbing a big influx of Latinos (lots of Uruguayans, for whatever reason), Hmong refugees who had been resettled there, and of course it had an African-American population from the great migration north of the Depression and war years. All of this with a scarcity of jobs, far from the big city.
The early days of the HIV epidemic, as a social, political and cultural phenomenon in African American, Latino and/or Haitian communities, would make another good dissertation; as would the remnants of the New Left as the counterculture 60s (which lasted from 1964 to 1975) faded away in the 1980s and 90s.
My files would have been a good resource for any of those: lots of pertinent interviews, survey data, and minutes of meetings where highly knowledgeable key activists were debating the state of affairs and what to do about in great depth. It's possible that the relevant organizations still have some of it in their archives but I doubt it. Leadership has moved on, the times have changed, I expect that at some point they did the same file purging I did. So all that is gone.
Why didn't I hold on to the files? Basically, I consider the probability vanishingly small that anyone with an interest in these little bits of history would ever track me down and connect with my yellowing pieces of paper. I've got enough stuff to schlep and organize, I just can't keep it all because someday, some way that I can't possibly predict somebody might be interested in it. And I don't think any university library is going to want to catalog and archive my papers when I'm gone either.
How much of what we think we know about the past is a function of what documents just happened to survive? I know historians worry about such questions all the time, but it was interesting to hold some pieces of the past, not entirely insignificant, in my hands, and realize that I am part of the age old process of selective memory.
Friday, November 19, 2010
Hang up and drive!
So sayeth Ray LaHood. And he's right. As an irredeemable pedestrian, I am tired of nearly getting killed 5 times a week by idiots sailing through stop signs while steering with their knees while yelling, "So she was like, 'No way!' and I was like 'Way' and she was like 'No way' and I was like, 'Whatevah'" into their phones.
World of Illusion
I'm reading Joseph Stiglitz's book Freefall: America, Free Markets, and the Sinking of the Global Economy. (WW Norton and Company, 2010)
This isn't a review, per se -- I haven't even finished it -- but some reflections. Stiglitz is a prominent economist -- indeed a winner of the phony "Nobel Prize" that economists give each other -- so it's comforting to see him agreeing with what I have maintained here all along.
Stiglitz says, quite directly, what I have also said, that economics, as taught, practiced and promulgated, is a form of theology, not a science. This is a specialized use of the word theology, by both of us. Economists don't talk about God, but they use the methodology of theologians. Theologians begin with received truths, purported facts written down in scripture or declared by priestly authorities, and construct edifices of thought on these assumptions. Some of their effort is devoted to spinning out consequences, whether descriptive, explanatory, or prescriptive (i.e. moral) from their assumptions. Some of their effort is devoted to vindicating the assumptions in spite of the manifest failure of observable reality to correspond to them. For example, the problem of theodicy - how can God be all powerful, just and compassionate, given that the world does not exhibit justice or goodness?
Economists proceed in exactly the same manner. They make a large number of assumptions, all of which happen to be rather obviously false. They build an elaborate edifice of theory based on those assumptions. Then they forget that the assumptions are false and insist that reality corresponds to their theory, even though anyone can see that it does not. Many of the people who engage in this sort of exercise are among the most prominent academics. They receive salaries much higher than professors in other disciplines, they receive high level political appointments, and their absurd beliefs are central to much of the political and policy discourse in the United States and elsewhere in the world.
The prevailing central assertion of these theologians for many decades has been that an entity called the "Free Market" efficiently allocates resources and maximizes prosperity, is "self-correcting," i.e. it maintains itself in an "equilibrium state" from which goodness flows, and it works best when government intervenes the least. Taxes and regulations can only damage its mystic perfection.
To be sure, they admit that in exceptional circumstances, so-called "market failures" can occur. Here and there we may need to tweak things a bit. But these exceptions can best be understood in light of the prevailing truth of the God-like Free Market.
This is unalloyed, irredeemable nonsense. No such entity as this so-called "Free Market" exists, has ever existed, or ever could exist. Markets are social constructions, not forces of nature. In wealthy, technologically advanced and complex societies such as ours, markets are creatures of government, and they depend on continual, sustained and massive government action and intervention to exist and to function. They are not self-correcting, they do not allocate resources efficiently, they do not maximize prosperity, especially when regulation is minimal. The question is not whether they are regulated, but rather how -- for whose benefit.
I will say more about this in coming days. For now, I will leave us with this. We are trapped in a discourse that takes the word of these charlatans -- and I mean you, Alan Greenspan, and Greg Mankiw -- as genius. In fact, the technical term for it is bullshit. A couple of basic points. Lower taxes are not associated with higher economic growth. Reduced regulation is not associated with higher economic growth. Cutting taxes and regulation does not cause there to be more jobs or more national income. These assertions are indeed, as George W. Bush said, "Economics 101," and they are also false.
Thursday, November 18, 2010
Buddy, have you got the wrong blogger
One of the interesting perks of blogging is that I get all sorts of pitches from publicists. It's surprising how many academic physicians are paying flacks to promote their breakthrough research, that the Nobel committee has somehow overlooked. Medical device manufacturers, drug pushers and even outpatient surgery centers think I might just throw them a mention here.
Not to be.
Even weirder, I would say, or maybe not, are the woo-meisters, the purveyors of the mystic arts and the miracle cures that "They" don't want you to know about. I consider these pitches weirder because, while I'm likely to ignore the former category, I'm likely to trash the latter. As I shall now proceed to do.
The first comes from a "manufacturer and marketer of leading natural supplements that promote optimal joint health." Well, no they don't. There was a flurry of interest a few years back in glucosamine and chondroitin, constituents of cartilage, as possible treatments for osteoarthritis. Later, more rigorous trials have been largely negative -- i.e., it doesn't work -- though perhaps equivocal in allowing some modest benefit for some people with moderate to severe joint pain. While no benefit of these supplements has been demonstrated, they probably won't hurt you, but they aren't likely to do you much good either.
So okay, selling this stuff isn't the worst scam out there. However, what is definitely a scam is the pitch this company uses. Their press release is headlined "Patients fire doctors over trust issues; PATIENTS GROWING WEARY OF DOCTOR/DRUG COMPANY RELATIONSHIPS SEEK ALTERNATIVES; More People Trust Own Instincts Rather than Endure Misleading Consultations." They cite a report in the Archives of Internal Medicine to the effect that most physicians accept items of value from drug companies. They exaggerate -- mostly we're talking the triangular plastic pen and the Post-it pad, but they go on about trips to exotic locations, speaking fees, and fancy dinners. Only a small minority of physicians nowadays get major gifts from drug companies, but it does still happen, it is corrupt, and I'm agin' it.
Nevertheless, it does not follow that you should stop consulting physicians, abandon their prescriptions, and depend on your own "instincts" to treat yourself from the snake oil aisle. In case you didn't notice, this company is itself making money by selling the stuff. So why should you trust them? Your doctor might have gotten a free pizza during his residency, but he isn't getting kickbacks from the drug companies. Probably. And he does at least have treatments available for which there is good evidence.
Worse is an "Ayurvedic M.D. and Naturopathic Physician," who is co-founder of a company that markets "ayurvedic herbs." He wants me to practice breathing exercises appropriate to my "dosha," or "natural constitution." I was once told that I'm a Pitta, meaning I "tend to run warm, get easily irritated and impatient and experience heated digestion." Fortunately I'm not a Vatta, or I would be "be anxious and absentminded and experience flatulence and constipation." As a Pitta, I'm supposed to:
1. Open your mouth to form an “O” shape. With your mouth in this position, form a funnel with your tongue and place it between your lips*
3. Slowly inhale through your tongue and feel the breath reach your heart
4. Relax the tongue and mouth, and then exhale through your mouth
5. Repeat this exercise 16 times, twice a day
* If you cannot form a funnel, bring your teeth together and inhale through your teeth instead
While the joint supplements are dodgy, this is total bullshit that the guy pulled out of his orifice of flatulence and constipation, after first getting his head out of the way. He then reinserted it. The mystery is why anybody believes this garbage.
The medical profession needs to clean up its act in many ways, not least because the ethical lapses create an opening for con artists. I hope the top docs will take this to heart.
Wednesday, November 17, 2010
The Quality of Quality
As Kathy noted on my previous post, there can be a lot to process when you're doing focus groups or any form of qualitative social research. We often hear confidences from our friends and family, have to respond to trauma in our own lives and our loved ones' lives, and live through hard times. Health care and social service providers obviously have to interact with very sick, dying and bereaved people as part of their daily routine. But there is something particular and particularly challenging about hearing tragic stories as a researcher.
I have to do my best not to influence how people present themselves, or steer the data in any direction. Normally, when it's appropriate to offer sympathy or reassurance or advice, that's what sane people do. Sociologists, however, ordinarily have to be very careful not to become a part of the real life of the people who we're trying to understand. (There are exceptions, mostly from the anthropological tradition, where investigators enter life worlds. But that's not what I was doing yesterday.)
That doesn't mean we don't care, or they're just specimens. If people really need help right away, of course we'll try to get it for them, and in a real emergency we'll step out of our role if we have to. In fact, I really have to be in the moment, I really have to empathize and understand, so I can figure out what questions to ask and where the discussion needs to go. But I also have to stay in my role of an observer and data collector. It's very taxing. Fortunately, in the situation I just worked in, the people were supportive of each other -- which is an observation -- so I didn't have to feel so stressed about it.
With the development of cheap electronic digital computing, social science, which had once been a largely descriptive discipline, became much more quantitative, and obsessed with statistical analysis and mathematical models. Qualitative methods fell out of favor. They were widely seen as intellectually inferior, not really scientific, more akin to literary art.
Fortunately we're getting past that. Fancy math is worthless if you don't understand what it is you are counting. We got to the point where our reductionism was squeezing the juice out of life. Human social interaction is different from biological processes because it has a particular kind of meaning for us, that we don't have very compelling ways of collapsing into few and definite categories that have specific, quantifiable relationships.
Because it is easy to turn survey data into mathematical models, survey methods became extremely popular in the social sciences, but as the saying goes, garbage in, garbage out. The investigator decides how to phrase the questions, and what responses to offer. Whether it makes sense to you, or means very much to you, as a respondent, is not the researcher's problem -- and we all know how annoying it can be to respond to a survey that doesn't ask the right questions, or asks them the wrong way, or doesn't let us give the answer we want to give.
On the other hand, just because I talk with some people and I see particular meaning in what they say to me, or to each other, doesn't mean you necessarily have to believe that my insights are the right or most important ones, or that those people are like others. We need ways of cogently defining units of meaning in social interactions and people's social worlds, counting them, and testing their associations with each other. It's a slow process, working back and forth between qualitative induction and quantitative deduction, and the average lay person probably doesn't think we've really gotten anywhere. But we have. A lot of what we have learned, however, people don't want to believe. But that's a problem for another day.
Monday, November 15, 2010
So what the heck do I know?
I'm involved in various forms of research based on the premise that "patient centered communication" is like, you know, good. That means that doctors encourage patients to say what's on their minds, set shared agendas, engage in shared decision making, enter patients' life worlds and understand how their values and goals intersect with biomedical understanding to shape the right choices for them, yadda yadda yadda.
This is, of course, in contrast to the old idea of medical paternalism where the doctor tells us what to do and we follow orders.
So, as part of this whole program, I'm running focus groups with people with HIV to talk about their relationships and communication with their doctors about antiretroviral medication taking and other such issues of their own behavior. So what do they like? It turns out they like it when doctors scold and yell at the people who screw up. That proves the doctor really cares.
At least that's what they tend to say when I ask them. It does not follow that it works in real life, but still. The life of a social scientist is a continual carnival of surprise and wonder.
(I did two focus groups today, which is actually fairly grueling. I have to do two more tomorrow then fly back to Boston. And no, I don't get time and a half.)
Sunday, November 14, 2010
Dear Intelligent Designer
It seems to me that for whatever reason, you don't get a lot of feedback. People just seem to accept things as they are, and even give thanks for it all, without letting you know what they like and don't like. I don't see why you wouldn't appreciate a little honest, constructive criticism.
Obviously, there's plenty of good stuff, that goes without saying. You know how it is, criticism always tends to focus on the negative because there's just more to say about it. So take it as stipulated that from my point of view, at least, it's good that there's something rather than nothing. Or at least I think so -- if there weren't anything, obviously I wouldn't be here to be disappointed so that gets a little tricky philosophically and all that. And if I weren't here, then there would be nothing as far as I'm concerned, except that I wouldn't be concerned -- well let's just leave it at that. Anyway, I'm here and so are the necessary conditions for that to be true, so you're certainly doing something right. And there is stuff for me to enjoy.
But . . . First of all, you're entitled to your own interests and foibles. I don't really get the thing about the beetles but I'm okay with it. There are a lot of little things that bother me, however, which don't really make any sense, e.g. poison ivy. What the heck is the point of that? Mosquitoes don't really seem necessary, either, or bedbugs. Lots of stuff like that which I just don't get.
But then there are more serious issues, where you really could have done a better job with the design. For example, the baby's head is too big for the birth canal. This causes no end of trouble. And the lower back -- the spine has a counterproductive curvature and it just doesn't hold up very well for a lot of people. Then there's the appendix - if it does any good at all, which I doubt, it's a lot more trouble than it's worth. Also, you didn't do a very good job separating the windpipe from the esophagus. People get food stuck in the bronchi all the time and like, die. Unless there's someone around to give them the Heimlich maneuver, which I have to point out was invented by Heimlich, not you. Even if you did invent Heimlich there's no particular reason why you couldn't have revealed the maneuver a few thousand years ago, along with the commandment to kill people who pick up sticks on the sabbath.
I could go on. There isn't enough room in lot's of people mouths for all their teeth. Osteoarthritis. Alzheimer's Disease. Childhood leukemia. All totally unnecessary and the result of basic design flaws. You're supposed to be omniscient as well as omnipotent, so it seems to me you could have done a much better job if you really cared. It's not too late to make a few fixes, you know? You might find yourself better appreciated.
Friday, November 12, 2010
I had to read a European journal to learn about this
It seems that Kenny Lin, a medical officer for the U.S. Agency for Healthcare Research and Quality, has resigned his position in a controversy over recommendations for prostate cancer screening. The story is quite revealing.
The U.S. Preventive Services Task Force was scheduled to vote at a meeting on November 1-2 on recommendations concerning prostate cancer screening. (Hmm, what else was going on around that time?) It seems the PSTF had voted preliminarily last year to recommend against routine prostate cancer screening for men of all ages, but then they decided to delay the official vote until this year. Then they canceled the meeting.
As Jeanne Lenzer reminds us, writing in BMJ (it's indecent to discuss this sort of thing in the United States, don't you know), reminds us of what happened when the PSTF recommended against routine mammographic screening of women in their 40s. Specifically, the excrement hit the ventilator and and everybody from Sarah Palin to Deborah Wasserman Schultz, to her eternal discredit, started screaming about the Death Panels.
In the 1990s, the Agency for Health Care Policy and Research (now called Agency for Healthcare Research and Quality), which sponsors the USPTF, recommended against spinal fusion surgery. The spinal surgeons, who needed to hold on to their horse farms much more than they needed to provide appropriate medical care, succeeded in getting Congress to eliminate the agency entirely. Funding was eventually restored, but at a much lower level.
Prostate cancer treatment is a river of gravy for surgeons, oncologists, and radiologists. They don't want to see it slow down. AHRQ now says the meeting will happen in March, safely after the election. We'll see. But we will never get health care costs under control if we can't make these decisions based on what's good for people, not what's good for business.
Wednesday, November 10, 2010
I ask once more: What is wrong with these doctors?
Michael Rothberg and colleagues surveyed some cardiologists and their patients who had undergone so-called percutaneous coronary intervention. That basically means sticking a long tube into the femoral artery in the groin, and guiding it to the site of a blockage in a coronary artery where various implements can then be used to open the channel.
It is an absolutely accepted fact that in people with stable angina (as opposed to acute rupture of a plaque) this procedure does not reduce the risk of a future heart attack, or fatality from a heart attack. Its only benefit is that in some cases, it can relieve symptoms of angina. Get that straight folks.
It often happens that people go for a cardiac catheterization, intended to visualize any obstructions in the coronary arteries, and if one is found, they get the PCI right then and there. These investigators found that 88% of patients who underwent catheterization, and 85% of those who actually had a PCI, believed it would reduce their risk of a heart attack -- even though they all said their cardiologists has discussed the risks and benefits of the procedure with them. Some of them might have misunderstood what the doctor said, but it turns out that 37% of the doctors also believed that -- and remember, it isn't true.
Oh yeah -- presented with two scenarios, 70% of cardiologists correctly stated that there would be no benefit of PCI, but 43% said they would do it anyway. Commenting on this mystery, the authors write:
Lin and colleagues* have attempted to explain why cardiologists continue to perform elective PCI for patients without clinically significant angina. They found that cardiologists' decisions were based on factors other than perceived benefit, such as patient expectations; medicolegal concerns; and the “oculostenotic reflex,” in which any amenable lesion receives a stent. Although cardiologists acknowledged that there was no evidence to support the practice, they believed that arteries should be opened if the procedure was technically feasible and low risk.
Shorter version: They just do it for the heck of it. And even better, they get paid!
So let's bring on the death panel, and put a stop to this. It's our money, and our hearts.
*Lin GA, Dudley RA, Redberg RF. Why physicians favor use of percutaneous coronary intervention to medical therapy: a focus group study. J Gen Intern Med. 2008;23:1458-63
Tuesday, November 09, 2010
Yep, this guy is actually a member of the U.S. House of Representatives
I probably should be keeping up my Sunday sermons, but what the heck, Tuesday is just as good a day for one. I don't think Shimkus is an idiot, per se; nor do I think he is insane, per se. He is, however, religious, and I am hard pressed to tell the difference. People can hear voices in their heads commanding them to do all sorts of pointless acts, or to hold beliefs directly contrary to observable reality, and they are by definition psychotic unless they claim they are hearing the voice of the culturally endorsed God.
Now, even if Shimkus happened to be right about God and Noah, climate change is not expected to "destroy the world," it's just expected to be a really big pain in the ass, and God didn't promise to spare us that. (Nor has he.) But logic aside, you can pluck any old arbitrary bit of nonsense from the Bible to prove just about any point you want to make. Most people just concentrate on the parts they like, and pretend the rest of it isn't there. But God didn't just make a covenant with Noah. He commanded us to kill people who pick up sticks on the Sabbath, and to drive people with skin diseases into the desert to die, among other interesting ravings. And of course, according to the last book in the Bible, God did promise to destroy the world after all. So I guess you just can't depend on anything the old fart says.
Given that God is a fraud and a psychopath, I think we should just go ahead and toss him on the dust heap of history. It's time for humanity to grow up.
Monday, November 08, 2010
Kill the bastards
None of these defendants is a poster boy for abolition of the death penalty. Hayes's partner, who will go on trial in January, probably gives defense attorneys even less to work with than Hayes did. As far as I can tell, abolitionists have had little to say about these cases, probably feeling that discretion is the better part of valor.
I hereby stipulate:
- There is absolutely no doubt of guilt in either of them. (The Nashua jury hasn't returned a verdict as I write but still . . . )
- The depravity and moral offense of the crimes is extreme. (Yes, the scale is small; we can talk about war crimes and genocide another time.)
- There are no substantial mitigating circumstances or factors in either case.
- There is no issue of racism or discrimination. All the relevant parties are white and of average class background.
As many have said, if the death penalty doesn't apply here, it never applies. These are slam dunks. (Nevertheless, the Hayes jury took almost four days to decide on the sentence, and evidently some jurors started off favoring life in prison.)
So why do I wade in here, where it is perhaps best not to tread? Because here is where I feel we must take a stand. If you read the comments on news articles about both cases, you will see mobs howling for vengeance. Many commenters make a great effort, and seem to take great pride, in trying to imagine the most gruesome tortures for the guilty, striving to outdo in their own imaginations the very crimes they claim to abhor.
That is, in the end, the only justification for having the state kill these men: vengeance. It obviously will not restore anything they destroyed, will not deter anyone else -- people who do such things have no thought for the future. All it accomplishes is to bring all of us a tiny bit of the way into their moral universe. I prefer to remain outside.
Sunday, November 07, 2010
Windham County
Now that I'm really dividing my time between the city and the country, I'm getting a more intimate, personal feel for rural culture and society. As you know, politically the country folk lean much more Republican. It doesn't really make sense in terms of their interests, at least if you want my Heller School fueled policy analysis. But I do have some sense of some of the reasons.
For one thing, people experience much less in the way of obvious direct returns on their taxes. My town has no police department, and little occasion to want police services. We do pay the state for use of the state police, but they are hardly ever seen. We have no publicly funded trash pickup. We have no commercial district to speak of and so no need for enforcement of regulations on potentially obnoxious businesses, or elaborate land use planning and zoning. We pay a small fee to a district for sanitary code enforcement at our single restaurant/grocery store/bait shop, but most people are probably unaware it even happens. We have a volunteer fire company.
The town maintains a baseball field and a couple of tennis courts, but doesn't provide any recreational programming. (The non-profit historical society and other groups sponsor activities.) The town maintains and plows some roads, and of course we pay for public education, now entirely through a district. (Our elementary school recently closed.) There is no community health center anywhere near by -- you have to drive 30 miles for a doctor. There is no public transit of any kind. Without the state college and community college system, people in rural Connecticut would have no chance at higher education, but they still have to pay more than they can afford for it and probably don't think of it as a benefit of their tax payments. You get the idea.
No wonder people have the feeling their state and federal taxes are just disappearing to who knows where; and town taxes seem bizarrely arbitrary. In addition to real estate, horses are taxed, but no other species of animal. Wagons and carriages are not taxable, but tractors are, unless you're in the farming business with revenues of at least $15,000 a year, in which case there is an exemption. Mechanics' and carpenters' tools are taxed. In other words, there's a tax on self-sufficiency and small scale enterprise, which is all the people have since there aren't any jobs to speak of nearby. It's insane, and I happen to personally resent it.
Now the fact is lots of people get disability, food stamps, and other assistance, but they don't talk about it and nobody notices. Of course lots of people get Social Security and Medicare, but they don't have much formal education and they are very easy to deceive and to scare, which is what the Republicans do. And it works. But it's not just a communication issue. We really do need to do more for the country folk.
Friday, November 05, 2010
They're always ripping me off . . .
An overwhelming majority of older voters chose Republican Congressional candidates in Tuesday’s election. They were propelled in large part, we suspect, by distorted and inflammatory attack ads claiming that President Obama’s health care reforms would “gut” their Medicare coverage and implying that a Republican-controlled Congress would somehow rescue them. . . .
Those ads may have worked, but they were also misleading or dead wrong on several counts. First, there is no way to slow the rise in Medicare costs — essential to addressing the deficit — without some changes in the Medicare program. And despite all the talk of gutting, what reform calls for is a reduction in the rate of increase in payments to health care providers, to encourage more efficiency, and a scale back in the unjustified subsidies to the private Medicare advantage programs. . . .
John Boehner, the likely next House speaker, tipped his hand in late September, telling an audience at the American Enterprise Institute that he would push to “repeal the $550 billion worth of Medicare cuts; and let’s see how many votes that bill gets in the House and Senate.”
What Mr. Boehner has yet to explain is how he would pay for that $550 billion. Those savings are a major reason why health care reform is projected to reduce the deficit over the next two decades and to extend the life of Medicare’s trust fund for hospital insurance by 12 years, thus shoring up the very program that Republicans say they want to save.
Remember, you read it here first. But it is ultimately the responsibility of politicians who sincerely want to preserve and improve Medicare -- which by definition does not include Republicans -- to explain this. If Americans want a Medicare program that will be there for them and meet their needs as they grow older, we will have to restructure so it delivers more value for less money. And yes, there is plenty of room to do that. When John Boehner and the rest of the tools of plutocracy start demagoguing about "cuts" to the program, the president and the program's true champions in the Democratic party need to already be out in front, with the clear message that cutting costs means enhancing and preserving benefits. They aren't the same thing.
If you're looking for waste, fraud and abuse in government, start with the Department of Defense, and then go to Medicare. Spending less is the only way to do more for beneficiaries. But, obviously, that means that somebody won't be slurping up all that gravy any more. Those include drug companies, medical device makers, for-profit hospitals and nursing homes, and overpaid medical specialists. That's who's bankrolling Boehner and that's who's behind those dishonest attack ads. John Boehner, believe me, doesn't give a shit about Medicare beneficiaries.
Thursday, November 04, 2010
More is still less
Among the attack ads that helped trash Democratic candidates for Congress was one that claimed [your Congressman's] vote for Obamacare cut $500 million in Medicare benefits. The proposition that Republicans are going to be more protective of Medicare benefits than Democrats is obviously absurd, but it is true that the PPACA reduces growth in Medicare spending that would otherwise have occurred through a couple of mechanisms, including eliminating giveaways to insurance companies through the Medicare Advantage Program and squeezing some provider reimbursements.
Since the Republicans claim they want to fix the long-term federal deficit problem, obviously they have to be in favor of reducing Medicare spending, but don't count on them for honesty or even the most basic rationality. Scaring people works, so that's what they do.
If you've been reading this blog, you know that spending more on health care does not equate to better health. Right now, in the U.S., the opposite is true, and here's one more piece of evidence. These investigators, writing in NEJM, find huge geographic variations in the rate at which elderly people are given inappropriate prescriptions. Some drugs basically shouldn't normally be prescribed to old folks at all, others are inappropriate for people with specific conditions such as dementia. I should know, my father was prescribed quetiapine, twice, even though my mother had given the nursing homes written orders that he should not receive it. (There is a black box warning against giving it to people with dementia.)
We'll worry about exactly WTF is wrong with physicians another time, but it turns out that in Alexandria, Louisiana, 44% of elderly Medicare beneficiaries receive high risk drugs, compared to 11% in the Bronx. Nope, no idea why.
But, inappropriate prescribing is not related to total spending on drugs, but it is more likely to happen in regions with high overall medicare spending. So higher medical spending, far from leading to higher quality prescribing, is associated with worse prescribing practices. Will older voters ever understand that Medicare spending can, and must, be reduced in a way that actually improves their health care?
Until we can get this idea across, those dishonest political ads will still run, and we'll still elect lying hypocrites to congress.
Wednesday, November 03, 2010
To elaborate . . .
It's not really that most people are idiots, but most voters don't really understand much of anything about public policy. In particular, right now, they don't understand why they can't find a decent job, or maybe any job at all; why their savings evaporated if they ever had any; why their kids can't afford to go to college; why their house isn't worth anything; and why it just doesn't seem to get any better.
Now, to be sure, when voters try to explain what they think is going on or why they vote as they do it often sounds pretty goddamn stupid. "Keep your government hands off my Medicare" was a famous quotation from the summer of teabaggery. NPR interviewed an elderly woman yesterday who said, "I have to live on a budget, the government needs to do the same." Ahh, her budget almost certainly comes 100% from the federal government, which is the most important reason why government spending is increasing over time. People are furious about the Wall Street bailout, which was enthusiastically endorsed by John McCain and signed into law by George W. Bush, so they voted for Republicans.
Right now, the only thing that's going to get them a job is increased government spending, to supply the demand that's missing from the economy; and the only way their grandkids will have a shot at a better future is if we hurry up right now and spend a whole lot on renewable energy, efficient transportation, and other technologies of the future that private investment isn't creating.
But Democrats didn't tell them any of that. They were too chicken shit to make the case for saving the country from the disaster which will come upon us if the greedy psychopaths behind the modern conservative movement have their way. It's too damn bad.
Tuesday, November 02, 2010
Religion and morality
I deleted it immediately, but I recently had a commenter making death threats against PZ Myers on behalf of Jesus. (I thought about leaving it up for a while on the principle of res ipsa loquitur but I decided it was just too vile.)
I find it interesting that many apologists for religion claim that faith is the only possible source of morality. I have never heard of atheists threatening or wishing for violence against believers; whereas it is quite common for believers to perpetrate violence in the name of their God, threaten violence, call for God to smite the infidels, and/or predict that God will do so. What does that tell you about religion and morality?
I have to be very careful . . .
. . . about what I say here. I am a member of an NIH Scientific Review Group (SRG) -- these are the peer review panels that score proposals for NIH-funded research -- that will meet at the end of this month. That is a matter of public record -- the rosters of all SRGs are posted openly on the NIH web site. The text of the so-called Funding Opportunity Announcement that we will be reviewing -- in this case, a so-called PO1 or research program announcement -- is also posted for all to see. It's called RFA-AT-10-002, and it is issued by the National Center for Complementary and Alternative Medicine (NCCAM). Beyond that, however, I am pledged to absolute secrecy about the content of the proposals, my own critiques, and the SRG's discussions about them.
I doubt that Orac would be happy if he knew I was doing this. He, and many other advocates for science-based medicine, do not feel that the NCCAM should exist. They argue that there is essentially no such thing as "complementary" or "alternative" medicine. If an intervention is shown to work by convincing evidence, then it's medicine, i.e. doctors will use it and insurers will pay for it. It's only "alternative" if it hasn't been shown to work, and that's a pretty silly kind of alternative.
And indeed, NCCAM has spent a lot of money over the years evaluating "alternative" medicine and it has not found a single thing that actually works. You may say that's fine, people are spending money on all that jive, so if we show that it doesn't work, maybe they'll stop. Unfortunately, that doesn't happen. The snake oil salesmen going on selling, and the people go on buying.
However, I figure these funds are going to be awarded, so somebody might as well review the proposals on their scientific merit. In other words, it's dirty work, but somebody has to do it. And there may be some merit in this particular effort, to fund "Centers of Excellence for Research on CAM for Pain." Chronic pain often has no detectable physical cause; and people report benefit from techniques such as acupuncture, meditation, chiropractic, etc. Maybe these are so-called placebo effects, but okay, something about them seems to work, so we might as well try to figure out what that is.
Is that the best use of limited NIH dollars? I may not think so but Congress has decided that it is -- NCCAM is specifically funded by its own line item. So I will read with a critical eye and judge whether the proposed research is good science, and whether it can answer important questions. I hope that all the SRG members will do the same and that the proposers assigned to me are not disadvantaged by catching a skeptical reader. Am I doing the right thing?
Monday, November 01, 2010
Take that shot with a grain of salt
No doubt you have heard or read about the new "study" that finds alcohol is more harmful than heroin or crack. Wellllll .. .
It's not really a study. Dr. Nutt -- who was fired as head of a UK government advisory commission on drug abuse for saying that cannabis is less harmful than legal drugs -- basically got a bunch of people together, and they sat around and ranked drugs on the basis of various criteria of harm. Once they added up all the votes, alcohol won.
I'm not saying this is a useless exercise, but presumably, if they had recruited a different group of experts, they might have gotten a different result. Also, you might weight the criteria differently. And, uhh, one reason why alcohol is particularly harmful is because more people use it than any of the other drugs. Finally, they divided harms into those to the user, and those to others and "society." Tobacco gets off easy on the latter, in large part because it's legal. A lot of the harm done by many of the drugs stems from their illegality, whereas alcohol's harm profile is greatly enhanced by its acceptability and ready availability. Meth is down the list, even though it is extremely destructive to users, largely because it isn't very popular in the UK. So as a guide to public policy, this is pretty confusing.
I have my own opinions, obviously. Had I been on the panel, the whole thing might have come out differently, or I might have decided that the criteria are too vague and/or inappropriate. But, the basic idea that prohibition and other policy responses to drug use and abuse doesn't make any sense is one I totally accept.
Well I'll be hornswoggled
I read this whole thing and I thought,"well, at least they're up front about it." Then somebody told me The Onion is actually satirical. Who knew?