Conspiracy-targeted Campaigning from Romney

Slate has an interesting article about Romney campaign mailings that appear to contain buzzwords for chronic Lyme disease advocates in Virginia. Romney’s plan for Lyme disease includes these two points:

IMPROVE SYNERGY
Ensure that government agencies have an open line of communication and work with patients, researchers, doctors, and businesses in an objective, comprehensive manner.
SUPPORT TREATMENT
Encourage increased options for the treatment of Lyme Disease and provide local physicians with protection from lawsuits to ensure they can treat the disease with the aggressive antibiotics that are required.

Note the “aggressive antibiotics” line. This refers to a bogus medical practice of prescribing long courses of antibiotics, often in IV form, for “chronic Lyme” syndrome. While people can have chronic complications of actual Lyme disease, another, crankier disease entity has been promoted by irresponsible doctors who treat a syndrome similar to fibromyalgia, or chronic fatigue, or maybe even depression, with long-term IV antibiotics. These treatments are administered at their own clinics, usually without insurance paying for it (insurance companies can smell this BS and won’t cover it), at great expense because IV antibiotics cost a lot more to administer, and often without evidence of Lyme infection by tests or history.
This has been a season of bizarre political conspiracy mongering with everything from birtherism from Mitt Romney, Sheriff Joe’s craziness, magic Kenyan Telegrams, Aurora conspiracies, job numbers conspiracies, polling conspiracy theories from America’s least-accurate pollster Dick Morris, and my favorite Obama is buying bullets for the Social Security Administration to kill all Americans conspiracy theory. Now, rather than coming up with Obama conspiracies it looks like they’re trying to solicit vocal conspiracy theorists who think the pharma/CDC/infectious disease society illuminati are trying to suppress a bogus diagnosis their doctor has successfully treated by emptying out their wallets.
It’s very sad, really. People with a legitimate medical disorder, likely along a similar spectrum with fibromyalgia and chronic fatigue that have a disordered sense of pain perception, are being exploited by quack physicians who directly profit from a dangerous course of powerful antibiotics. Antibiotics are not benign drugs, and should not be used carelessly, as they too often are. And the non-evidence based used of megadoses of these drugs, often without any actual evidence of infection should result in a campaign to revoke these physicians’ licenses, not to solicit their votes by hinting at support of quack medical theories and protection of irresponsible physicians from liability. Is this a new all time low for a political campaign?

2nd US Hospital to do full face transplant – today at University of Maryland

The news was just publicly announced that the University of Maryland is now the 2nd hospital to perform full face transplant in the US. Just a handful of these procedures have been performed around the world, and they are enormously complex ethically, surgically and medically.
To begin with, long before the surgery even became a possibility, there have been years of work put into setting up such a novel transplant program. Besides obtaining approval for what is still an experimental procedure from an IRB, it is necessary to very carefully screen a population of potential recipients. A face transplant is still quite high risk, especially if the surgery fails because it has the potential to cause serious morbidity and mortality. So, patients selected for transplant have to be vetted very carefully. In the case of the first Chinese transplant, the patient stopped taking immunosuppressive drugs in favor of traditional Chinese remedies, and died soon after. This emphasizes the importance of choosing potential recipients that will reliably take their medications as rejection can be catastrophic.
This surgery took approximately 32 hours from start to finish, and involved a huge multidisciplinary team including multiple transplant and plastic surgeons to perform the procedure. These procedures involve very complex microsurgery to reattach the vascular supply, muscles and nerves to the graft, and, since the jaw and tongue were also transplanted, bones as well.
The surgery is also just the beginning. A life-long course of immunosuppression is required, at least until we can reliably determine how to induce immune tolerance to transplanted organs (this is an exciting field which has also been in the news). And since the jaw contains marrow, there is a risk of graft versus host disease from the transplanted bone.
Then there are the complex ethical issues with facial transplant.
More below the fold…
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CSPI overblows the cancer risk of caramel coloring in soda

The safety of soda has been in the news a lot lately. The news even seems bad for diet coke, which hits close to home for me given my diet coke addiction. The worst seems to be this correlative study proposing a link between diet sodas and stroke risk:

The study, which followed more than 2,500 New Yorkers for nine or more years, found that people who drank diet soda every day had a 61 percent higher risk of vascular events, including stroke and heart attack, than those who completely eschewed the diet drinks, according to researchers who presented their results today at the American Stroke Association’s International Stroke Conference in Los Angeles.

Disturbing news, however, it’s still just a correlative finding from the Northern Manhattan studyand until things are studied more rigorously, I probably won’t quit my current caffeine source. After all, it can reflect patients who are drinking diet drinks because they are diabetic, a known cardiovascular risk factor not excluded in their analysis.
Now the Center for Science in the Public Interest (CSPI) has entered the soda fray with a report suggesting the caramel coloring has unacceptably high levels of a carcinogen called 4-methylimidazole.

An independent study commissioned by the Center for Science in the Public Interest (CSPI) uncovered 4-methylimidazole, or 4-MI, in Coke, Diet Coke, Pepsi and Diet Pepsi at levels 4.8 times greater than those allowed in beverages in California.
4-MI is a byproduct of the reaction that produces the caramel coloring in brown sodas. The chemical has been found to be carcinogenic in animal studies.
The state of California has banned 4-MI in any amount that could potentially lead to one cancer case in 100,000 people. However the levels found in these 4 leading Cola brands indicated a lifetime risk of 5 cancers out of 100,000, assuming that people drink one soft drink per day. That risk rises to 10 cancers out of 100,000 people who drink only soft drinks containing caramel coloring.

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But what is the evidence this level of 4-MI could pose a health risk?
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Accountability in Science Journalism: two recent examples of failures in the NYT and Forbes

ResearchBlogging.orgEd Yong demands higher accountability in science journalism and has made me think of how in the last two days I’ve run across two examples of shoddy reporting. These two articles I think encompass a large part of the problem, the first from the NYT, represents the common failure of science reporters to be critical of correlative results. While lacking egregious factual errors, in accepting the authors’ conclusions without vetting the results of the actual paper, the journalist has created a misleading article. The second, from Forbes, represents the worst kind of corporate news hackery, and shows the pathetic gullibility of reporters regurgitating the fanciful nonsense of drug companies without any apparent attempt to vet or fact-check their story. With a google search the facts are smashed.
The first article Digital records may not cut costs, I think is typical of most science reporting. That is, it’s not grossly incompetent but it overstates the case of the article involved and fails to amplify the shortcomings of the research.
The NYT article is describing this article from Health Affairs, which caught my eye before the NYT article was even published because I believe electronic medical records (EMRs) will prevent redundancies and lower costs. So, am I wrong? Will EMRs save us money or possibly increase redundancy as the HA article suggests?
I haven’t given up hope. This article is a correlative study based on survey data, and proves precisely nothing.
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Forcing Doctors to Perform Unnecessary Medical Procedures is Unethical and Unlawful

Many bloggers and commentators have expressed outrage over the decision by Virginia to require ultrasound examination, possibly transvaginal ultrasound, prior to women obtaining an abortion. From Bill Maher to Dahlia Lithwick people are outraged and have even suggested that it should be considered rape to force women to undergo vaginal examination by ultrasound prior to receiving abortion. Worse, it’s clear from statements like this one by delegate Todd Gilbert, that there isn’t a medical concern related to this intervention. It’s simply designed to humiliate women and interfere with the doctor patient relationship with exclusively anti-abortion motivations:

“the vast majority of these cases [abortion] are matters of lifestyle convenience.” And, 

”We think in matters of lifestyle convenience and in other matters that it is right and proper for a woman to be fully informed about what she is doing.

This just reflects how stupid these guys are, because anyone with half a brain could come up superficially plausible defense of the statute from grounds of medical safety. They’re just too brainless to do so and clearly are just trying to interfere with women and their doctors as they try to make a difficult decision.
There are some indications for ultrasound prior to abortion. Many physicians performing the procedure or especially offering medical abortion might perform a transvaginal ultrasound prior to proceeding. It can serve a few useful purposes. It can help confirm intrauterine pregnancy as well as uterine location. It may be needed to assess patients in their postoperative exam or medical follow up visits to rule out retained products of conception. In cases of uncertain dates, it can give you gestational age of the fetus, which may be critical in determining the appropriateness of the subsequent procedure used. After all, medical abortion is typically limited to the first 9 weeks and uncertainty about gestational age should result in ultrasound prior to use of medical abortifacients.
However, neither the FDA nor any professional organization of obstetricians and gynecologists indicate ultrasound should be a required component prior to medical or surgical abortion. The procedure is often unnecessary. So, what Virginia has done has legislated a requirement for an unnecessary medical procedure, unsupported by any professional medical association, on a specific subpopulation of women. Given the history of forced sterilization in Virginia, you’d think they’d be more sensitive on this issue. This is the state where Buck v Bell brought the issue of forced medical procedures to light.
This statute cannot, therefore, stand on either medical ethical or constitutional grounds. The state legislature can not force me or any other physician to perform an unnecessary, and therefore unethical, medical procedure. The state legislature can not pick on a subpopulation of citizens and force them to receive an unnecessary medical procedure.
I don’t think this law will stand, but it once again will require a legal fight, waste of time and resources, and all of this once again in a effort by governmental busybodies to interfere in women’s health decisions in a punitive fashion. The Republicans need to watch out. This is just another indication of a the size of the assault on women’s reproductive rights, and if they keep pushing, they’re going to see what a mistake it is to piss off 51% of the population.
**Update: I also noticed from Lithwick’s article Virginia has enacted a personhood law saying life begins at conception. More idiocy. This is like Indiana legislating the value of pi = 3. It is unscientific and illogical. Life does not begin. It is continuous. There is no dead state between parents and offspring. Sperm are alive, eggs are alive, the fusion of the two is alive. Instead they are legislating what constitutes life that is important, or more likely “ensouled”. As a fundamentally philosophic/religious and ultimately arbitrary point, government has no business legislating such a thing. But legislating that life has a “beginning” is biologically ignorant.

Drug Shortages Reveal the Free Market is Failing Our Sickest Patients

**Update, the NYT has an editorial in their Sunday edition recommending the passage of two bills in congress requiring advanced notice from drug manufacturers in event of likely shortage.
i-1ae05c713060a45402a652d348e56148-pngHealth affairs discusses the increasingly frequent shortages of critical, life-saving, generic drugs. This is a serious problem that seems mostly limited to the U.S. healthcare system, and may adversely affect you or someone you know.

Many of the same drugs are not in such short and unpredictable supply in Europe, where in some cases they carry higher prices. This provides one major clue to the root cause: It’s the money.
Three of every four drugs on the US government’s shortage list were sterile injectable drugs, according to a report by HHS. For the most part, these are relatively low-cost generics. Simply put, most of those drugs are not very profitable to produce and sell, or supplies of them would not have dried up.
At an online presentation for journalists in November, Valerie Jensen, associate director of the FDA’s Drug Shortage Program, provided a casebook example. She mentioned the price of the tried-and-true sedative propofol, a lethal dose of which was found to have caused the death of singer Michael Jackson: The cost is forty-eight cents for a twenty-milliliter vial. “The older, sterile injectables are not economically attractive” for manufacturers to produce and market, Jensen said. Other generic drugs can have higher profit margins.

Propofol, one of the most frequently used drugs by anesthesiologists, is in increasingly short supply. I get emails from my hospital about which drugs are in short supply as physicians then try to ration these drugs for the most critical cases. In my own experience in the last year I’ve seen shortages of everything from injectable calcium gluconate (for electrolyte deficits), to levophed (a life-saving pressor used in critical care), metoclopramide (anti-nausea), and fentanyl (a powerful and useful short-acting narcotic). The FDA has a full list of recent shortages and it’s scary. Parents are having trouble finding drugs for their kids’ ADHD, vital chemotherapeutics like daunorubicin and doxorubicin are in short supply, dexamethasone (a powerful steroid), valium, digoxin (a staple of congestive heart failure and anti-arrhythmic treatment), diltiazem (hypertension and anti-arrhythmic), phenytoin (anti-epileptic also often used in acute brain injury), furosemide (an ubiquitous diuretic), haloperidol (anti-psychotic and sedative), isoniazid (a antibiotic used in TB), ketorolac (an excellent anti-inflammatory and analgesic), levofloxacin (a quinalone broad spectrum antibiotic), methotrexate (immune modulator), midazolam (a great short acting sedative), naltrexone (for reversing opioid overdose), vasopressin (another pressor) all are in short supply.
The drugs affected span all classes, what they have in common is they are all generic. Since there is too much competition in generics and too little profit margin, drug companies do not have a financial incentive to maintain adequate stocks to keep the drugs cheap and available. Shortages, if anything, increase profits because then the prices become artificially inflated.
Manufacturers, not surprisingly, blame the FDA, however the FDA hasn’t changed its standards despite increasing problems with shortages due to contamination or impurity. And that’s just for manufacturers in this country, fully 80% of the medications are produced, or active ingredients are produced, abroad. The main problem seems to be a concentration of production to a handful of companies that have adequate production capacity to compete in the generic market:

There is also a high level of concentration in US manufacturing for such drugs. That leaves little redundancy in the market as there would be for, say, generic statins. Three companies in particular–Hospira, Teva, and the Bedford Laboratories division of Boehringer Ingelheim–have been involved in selling 71 percent of the sterile injectable market by volume, the government says.7 All three have had manufacturing problems in the past two years.
With such consolidation as well as tight inventory management practices, the specialized manufacturers of injectable drugs lack the flexibility to adapt to manufacturing disruptions. If one plant shuts down, it may overburden the limited remaining competitors or choke off the supply entirely.

It’s hard to estimate the effects of these shortages, I don’t have good data on the damage done nationwide, only my personal experience. In particular, I remember during an ICU rotation running out of levophed, an incredibly important pressor that helps patients who are in shock from becoming fatally hypotensive.
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Two great obesity articles from the NYT and what they mean for you

A few weeks ago Tara Parker Pope wrote The Fat Trap for the NYT and once I read it I started sending it to other doctors I know. It is a great summary on the current knowledge of why we get fat, and more importantly for those of us that already are tipping the scales, why is it so damn hard to take that weight back off. (I’ll discuss Young, Obese and Getting Weight Loss Surgery nearer the end)

Beginning in 2009, he and his team recruited 50 obese men and women. The men weighed an average of 233 pounds; the women weighed about 200 pounds. Although some people dropped out of the study, most of the patients stuck with the extreme low-calorie diet, which consisted of special shakes called Optifast and two cups of low-starch vegetables, totaling just 500 to 550 calories a day for eight weeks. Ten weeks in, the dieters lost an average of 30 pounds.
At that point, the 34 patients who remained stopped dieting and began working to maintain the new lower weight. Nutritionists counseled them in person and by phone, promoting regular exercise and urging them to eat more vegetables and less fat. But despite the effort, they slowly began to put on weight. After a year, the patients already had regained an average of 11 of the pounds they struggled so hard to lose. They also reported feeling far more hungry and preoccupied with food than before they lost the weight.

Who among us can’t identify with that story? If you can’t you’ve been thin all your life and can go suck an egg. But for those that have carried extra pounds it’s part of the yo-yo routine of dieting. But why is this? Were we permanently programmed for a preset weight and will feel as though were starving below it? If this is the case, why is obesity increasing now, in the last 20 years? The answer suggested is more subtle, but the fascinating thing is, your body’s set weight might be a real thing. It’s just not programmed from birth.
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Are Patients in Universal Healthcare Countries Less Satisfied?

ResearchBlogging.orgA dishonest campaign has started against healthcare reform in this country and the first shot has come from Conservatives for Patients Rights (CPR), a group purporting to show that patients in universal health systems suffer from government interference in health care. To bolster their argument, they have a pile of anecdotes from people around the world who have suffered at the hands of evil government-run systems. The problem, of course, is that anecdotes are not data, it is impossible to determine the veracity or reasonableness of these claims, and there is no way, ethically or practically, to respond to claims against doctors in these systems.

And should we be surprised? Every other country in the industrialized world has universal healthcare. Some are government run, single payer systems, others are mixtures of private and public funding to guarantee universal coverage. I would be shocked if you couldn’t find a few people to provide testimonials about how they’re angry at their coverage. After all, Michael Moore made an entire movie about such testimonials against our system.

So what do we do? How do we find out the truth when the ideologues and financially interested parties have started a campaign to muddy the water with anecdotal attacks?

We look at the data of course. And surprise, surprise it doesn’t support CPR’s assertions that our system couldn’t stand some improvement.

During the next couple of weeks, I think we should talk about what healthcare looks like here in the US and around the world. Rather than a few horror stories, let’s take an in-depth look at what’s happening in universal systems, and whether or not we should consider a change.

Let’s start with an examination of some data from the literature on different experiences people have with these healthcare systems.
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Obesity – A new study and what it means to be a “healthy weight”

ResearchBlogging.orgIn response to the conversation on “Obesity, Evolution and Delayed Gratification” on the main page and Razib’s coverage of a fascinating new study on the relationship to the lactase gene and obesity, I thought now would be a good time to write about an important new study that helps define the boundaries of what normal and healthy weights are in humans.

This study, entitled Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies is a whopper of a meta-analysis. That is, a study that increases the power of other similar studies by combining their results so that, in this case, data from hundreds of thousands of patients can be aggregated. Meta-analyses have their flaws, and I criticize them frequently when poorly-done or poor-quality studies end up being averaged-in with the results of better-designed studies, but this one is large enough and thorough enough that its results should not be dismissed.

What this study describes is the mortality, and causes of mortality, one observes when one sorts people by body mass index. Body mass index also has it’s flaws but it is a useful, if imperfect method of describing one’s relative contribution of body fat to their total mass. It is calculated by taking and individual’s body weight in kilograms and dividing by the square of their height in meters. “Normal” is defined between 18.5-25, overweight is 25-30, and obese is greater than 30. These numbers do not describe all people well, and you may be an exception to these predictions. This usually occurs if you have a large amount of muscle mass relative to your height, so Arnold Schwarzenegger would be obese according to these scales. However, most people are not Arnold Schwarzenegger and the scale fits, it’s better not to let the perfect spoil the good. One must also remember that it would be unethical to design a study in which we prospectively made people overweight or obese, since we suspect that will cause poor health, so this is necessarily a correlative study of BMI and health. But this information combined with what we know about mechanisms of cardiovascular disease, diabetes, etc., makes a lot of sense, and I believe in the context of the literature we can make a safe assumption the effects we see are causal.

Overall what the study suggests is that the current 18.5-25 recommended BMI is probably about right, BMI of 25-30 marginally increases morbidity and mortality, and BMIs much greater than 30 significantly shorten one’s life. The reason I like this study is that they have aggregated such a huge data set, they demonstrate a clear dose-response curve between obesity and mortality, and they’ve done a better job than most in teasing out the relationship between health, weight, smoking and other co-morbidities at all BMIs.

Let’s take a look at some of the data.
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What should a national health care system look like?

I was pleased to see president Obama deliver this address yesterday:

I was even more pleased because he has gathered the traditional opponents of healthcare reform around him and has convinced them to commit to reform in the US system. This is a positive sign. However, I’m concerned because, as with all political debates that challenge a dominant ideology – in this case free-market fundamentalism – we will soon see the denialists come out of the woodwork to disparage any attempt at achieving reforms that may result in universal health care coverage. This has, in fact, already begun, and typical of the tactics they selectively mention the British NHS. If you care to read a balanced article on the history and function of the NHS, you’ll probably agree it is wrongly demonized. What you will also see is that the denialists will ignore a few key facts which include:

1. The United States is the last industrialized nation that lacks a universal healthcare system. Once again, thanks to obstructive policies led by the free market fundamentalists, the US is trailing the rest of the world.
2. The US spends more per capita on healthcare than any other nation in the world.
3. Despite spending more, we get less. We have tens of millions who are uncovered – which does not mean they do not receive healthcare at all. They instead are treated in ERs, urgent care centers, or receive substandard care, and the state ends up picking up the bill anyway. So even without a planned universal health care system, you end up picking up the (higher) bill because the state has a vested interest in protecting hospitals from the economic collapse that would occur if they had to pick up the tab on every impoverished patient who doctors are ethically and legally obligated to treat.
4. Many national healthcare systems work. We will not hear about this from the ideologues who will soon harangue us with cherry-picked horror stories of long wait times and underfunded hospitals. You will likely not hear about Sweden or Italy or France, and I promise you will never hear them talk about Australia. For them to do so would be to admit to defeat of their fundamental premise that universal health care can not work.
5. Failures of national health systems are not related to universality but instead are due to chronic underfunding by government. If the British spent as much per capita as we did, they wouldn’t have the shortfalls in manpower and beds that they do.

We will of course hear a lot of chest thumping from the thick-browed morons about how the US is already perfect and can not learn anything from the rest of the world. We will hear how every other system in the world is imperfect, and that is why any reform is impossible. We will hear how this will lead to communism and socialism despite the fact that every other industrialized nation in the world has universal healthcare and amazingly they didn’t all go commy. In short, we are about to hear a bunch of denialist garbage designed to delay, to obstruct, to block, and drag down any meaningful action in healthcare.

But before that happens, let’s have a more balanced discussion on what a universal healthcare system could look like in the US.

Any discussion of changes in the US medical system must begin with a statement of principles guiding reforms in the system. Let’s start with some of the principles I would include, and I think most of us could agree on:
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