John Oliver, right on drug rep influence

It is amazing how powerful a free lunch is. And the data are real, that people tend to favor those who do nice things for them. That is why, despite new rules about the amount drug companies can give to doctors, or all the rules on disclosure, the pharma reps are always going to push the boundary to try to gain any advantage because it results in real world financial benefits to pharmaceutical companies.

Leave it to John Oliver to nail this. Reps are pervasive. They are influential. Their influence comes not necessarily from the right impulses of science and data, but from attractiveness and free food.

Since I’m a surgical resident, I am mostly immune to this kind of temptation. Not because I’m some kind of special human. Its because I only prescribe a tiny set of medications. In fact only really prescribe one type of drug – pain killers – because I’m a surgeon. I have no business screwing with people’s other meds. At the same time I get invitations to free dinners hosted by these companies designed to tempt even lowly residents like me into changing our prescribing practices. Oliver is right, these things happen.

My joy in this is, if I ever take up one of these offers, all I get is information about drugs I’ll never prescribe and an opportunity to antagonize drug reps, which I usually find entertaining. I have gone to them, gleefully, as I literally prescribe only 1-2 drugs ever, and they can tell me about whatever they want, it is totally irrelevant to me, and hey I get free food! Suckers. As a resident you search out free meals, it’s a matter of survival. If you bring a resident within arm’s reach of a shrimp platter it will be destroyed because we’re hungry and we feel the world owes us for all the other crap we have to endure.

So yes, this is a real. And while the idea there is a quid pro quo relationship is a wild exaggeration, we know, psychologically and because drug companies spend money on this that these tactics work. Money spent on advertising is effective. Money spent on wooing doctors to one prescription vs another will tempt enough to be profitable. I will show up and listen to a drug rep talk about their drug for a candy bar. The difference is, I prescribe almost no medications, so, at least in my case, it’s a losing investment for the reps. For most doctors who have to deal with these influences all the time, I’m sympathetic, it’s easier to listen to an attractive person bearing a free lunch than it is to independently investigate every new drug that is dropped on the market. And to be fair, this isn’t always a bad thing. We need to know about which products are out there and which are most effective for our patients. But a situation in which the drug company with the best reps, or the best market share, or saturation of the market, or whatever, wins, is not necessarily what is best for the patient.

There is a simple solution. Ban the practice of using drug reps and food. It’s not like pharmaceutical companies are selling placebos like herbal supplements. They aren’t devastated by the loss of advertisement. Usually what they’re doing is trying to push equivalent (but usually more expensive) medications, or gain market share for some slight advantage, or advertise some niche they think their drug should enjoy, or some off-label use that some physician should think a lot harder about before they decide it’s appropriate. We’ll still have access to the same meds, but the decisions will be based on things like journal articles, data and research. Instead of diverting money into advertising and drug reps bearing food (I am so jealous I’m not the type of doctor that gets all this free food), maybe they’ll spend the money on the research that bears results that should influence physicians in a legitimate fashion. If the only influence they have to bear is copies of peer-reviewed journal articles you will be sure docs are making these decisions based on the right information.

So let’s ban drug company practices which seek to influence physicians based on meals and perks rather than data. Let’s ban direct to consumer advertising too, because you know who is even easier to influence? The lay public who have little to no access or knowledge to interpret and understand the literature on appropriate treatments for illnesses. The United States is the only country that allows this, because basically every other country figured out long ago it is a terrible idea. Let’s stop all drug advertising period. If a drug company wants doctors to prescribe a drug, they should use the scientific literature to justify its use. Not free food, or stupid advertisements with animated bees, or smiling happy people pushing their kids on swings. Drug reps, if anything, should show up with papers, not sandwiches.

This is a gimme. While people shouldn’t overblow the effect here – most physicians have a great deal of skepticism to claims from reps and are very reluctant to change practice unless they provide good data – there is clearly some influence, and it’s not based on legitimate enticements, which are data, and the interests of our patients.

Antibiotics in Meat Do Lead to MRSA in Humans

I was extremely disturbed to see in the NYT’s letters a veterinarian’s defense of the practice of overuse of antibiotics in animals that suggested transmission of resistant organisms does not occur. Nonsense! It is abundantly clear that antibiotic use in animals results in resistant strains that then colonize humans. They are being recognized as the newest reservoir for strains of MRSA.

Unlike the GMO nonsense, this is a clear public health issue with a plausible (and demonstrated) mechanism of transmitted risk to humans. The author of the letter, Charles Hofacre, says two, wildly misleading things. For one, he suggests the antibiotics they are using are somehow substantively different from those in humans by saying, “About a third of livestock antibiotics used today are not used at all in human medicine.” Well, that means 2/3rds are the same and just because we don’t use the exact same antibiotics doesn’t mean they don’t share the exact same mechanism. If he’s trying to suggest resistance in livestock antibiotics isn’t relevant to human pathogens, he is just wrong, wrong, wrong. Second he says, “There is no proven link to antibiotic treatment failure in humans because of antibiotic use in animals for consumption — a critical point that is often missed. ” This is such a misleading statement I can’t believe an academic would say such a thing, as it assumes we’re just idiots. This suggests that there is not a transmission issue, or at least none of clinical relevance. But this is also wrong. There is extensive documentation of Methicillin-resistant Staph Aureus (MRSA) becoming more common in livestock, being transmitted to humans, and appearing in hospitals. There hasn’t been a “treatment failure”, because we still have antibiotics that work against MRSA, and MRSA is usually not pathogenic on its own without some failure of the host immune system, broken skin/non-sterile injection, surgery, chemo, etc. That doesn’t mean we should go around spreading MRSA! We have to start taking out the big guns to deal with MRSA infections when they do occur (we don’t treat colonization), and the more we expose these bacteria towards the better antibiotics, the more we’ll train them for resistance to those drugs. But it should be made clear, the transmission of resistant bacteria from farm animals to humans has been documented, just because the patients didn’t die doesn’t mean that there’s no problem here. This is just shameful.

Antibiotic resistance has existed since before we even used antibiotics and will only get worse the more we train the organisms to grow in the presence of antibiotics. These genes for resistance aren’t “new”, but not all bacteria carry them because there is an energy cost associated with production of proteins, and if it doesn’t benefit their survival, those bacterial strains wasting energy will become less common. If we constantly create a selective pressure on bacteria to maintain resistance genes, we are going to increase the proportion of bacteria that carry resistance, and thus the resistant organisms we are exposed to. Then, as we have to use more and more powerful antibiotics to address resistance, we create additional selective pressure on the organisms to carry more and better resistance genes (not all beta-lactamases are created equal), and as they mutate to become more effective, those effective resistance strains will eventually mutate into bacteria for which we have no therapeutic option. These are already starting to emerge as those who followed reports of the MDR-klebs outbreak at NIH know.

In my GMO thread I used the analogy that the beta-lactamase used for genetic modification of organisms by molecular biologists is like a “sharpened stick” it can use against weaker penicillins. This is why those resistance genes aren’t a danger for humans. They’ve been around forever anyway, all the bacteria that are going to carry them already do so we don’t even bother using weaker penicillins on those types of infections, and they can’t beat our stronger beta-lactam drugs like the anti-staph and extended-spectrum beta lactams. The multiple-resistance and pan-resistance bugs that we are finding in our ICUs are the “multiple nuclear warhead” bugs because they beat multiple classes of drugs as well as our extended-spectrum drugs. We’ve created these bugs by the steady application of selective pressure with exposure of the organisms to progressively more powerful antibiotics. The continued injudicious use of antibiotics in animals will invariably lead to the same phenomenon, just all over the place in communities and the workplace rather than just in the ICU. We are going to see a higher prevalence of resistant bacteria, those bacteria will mutate their resistance genes to become more and more effective, they’re already crossing over to humans and hospitals, and we’re going to have to use our big guns more which will speed up the loss of our antibacterials’ efficacy.

Some caveats. One, this represents more of a threat for farm workers than consumers, as MRSA is not carried in the meat itself, although it will likely contaminate the meat at higher frequency (this has indeed been shown) as the prevalence increases from slaughterhouse contamination. MRSA usually colonizes the outside of the animal, the nares, etc., not the inside of the animal. Two, standard practices of food handling will also decrease, but not eliminate our risk. Cooking meat and washing hands with soap after meat handling (which should be your standard practice) kills MRSA. Don’t prepare hamburger then pick your nose people. Clean surfaces on which meat has been prepared etc. However, the packaging, your cutting board, your trash can, all are likely to get contaminated if the meat was surface contaminated. Three, realize MRSA is not pathogenic in normal healthy people. But, something as simple as a cut can introduce staph and create a serious infection. Staph is everywhere, and the human body generally has no problem handling it. But when those defenses are down, MRSA reduces our therapeutic options. You don’t want that. Fourth, this is just one bug we may be exposed to, we’re also training the animals e. coli and enterobacter to become resistant too, and with poor food prep and exposure, you can get colonized with these bugs as well.

From a public-health standpoint it’s important that we reduce the prevalence of resistant bacteria we’re exposed to, so fewer of our infections will require the big-gun antibiotics. There is good news though, and we shouldn’t just develop a fatalistic attitude towards this problem. As we stop the overuse of antibiotics, selective pressure on the bacteria will cause some of them to shed the resistance genes, and there won’t be a reason for the bacteria to maintain and improve their antibiotic resistance genes. Without consistent exposure to antibiotics, they have far less selective pressure to produce proteins and maintain plasmids that provide them no advantage. While the resistance genes will still be out there (always have, always will), we can still benefit from common-sense measures that decrease their prevalence, and thus our individual risk of exposure to resistant organisms. And, the less we have to take out the big guns to treat infections, the fewer multiply-resistant organisms we’ll see.

There Are Legitimate Criticisms of Obamacare – Hospitals Should not be Penalized for Readmissions

Crazy ranting about impending socialism/fascism aside, there are legitimate critiques to be made of Obamacare. One policy in particular that raises my ire is penalizing hospitals over performance metrics and penalizing readmissions in particular. The way it works is, patients are admitted to the hospital, treated, and eventually discharged, but a indicator of failure of adequate care is if that patient then bounces back, and is readmitted shortly after their hospitalization:

Under the new federal regulations, hospitals face hefty penalties for readmitting patients they have already treated, on the theory that many readmissions result from poor follow-up care.

It makes for cheaper and better care in the long run, the thinking goes, to help patients stay healthy than to be forced to readmit them for another costly hospital stay.

So hospitals call patients within 48 hours of discharge to find out how they are feeling. They arrange patients’ follow-up appointments with doctors even before a patient leaves. And they have redoubled their efforts to make sure patients understand what medicines to take at home.

Seems reasonable, right? These are things that are part of good medical care; good follow up, clarity with prescriptions, etc. It should be the responsibility of hospitals to get patients plugged into the safety net, assign social workers, and make sure patients won’t fail because they lack resources at home. However, the problem arises when the ideal of punishing readmissions as “failures” crashes into the reality of the general failure of our social safety net:

But hospitals have also taken on responsibilities far outside the medical realm: they are helping patients arrange transportation for follow-up doctor visits, get safe housing or even find a hot meal, all in an effort to keep them healthy.

“There’s a huge opportunity to reduce the cost of medical care by addressing these other things, the social aspects,” said Dr. Samuel Skootsky, chief medical officer of the U.C.L.A. Faculty Practice Group and Medical Group.

Medicare, which monitors hospitals’ compliance with the new rules, says nearly two-thirds of hospitals receiving traditional Medicare payments are expected to pay penalties totaling about $300 million in 2013 because too many of their patients were readmitted within 30 days of discharge. Last month, the agency reported that readmissions had dropped to 17.8 percent by late last year from about 19 percent in 2011.

But increasingly, health policy experts and hospital executives say the penalties, which went into effect in October, unfairly target hospitals that treat the sickest patients or the patients facing the greatest socioeconomic challenges. They say a hospital’s readmission rate is not a clear measure of the quality of care it provides, noting that hospitals with higher mortality rates may also have fewer returning patients.

“Dead patients can’t be readmitted,” Dr. Henderson said.

This is a problem with the careless application of rewards and penalties tied to medical outcomes. While I think it’s a healthy response that hospitals are taking on more of the social work that formerly would have been the arena of government programs, there is another defense mechanism used when government creates perverse incentives in health care. When you create payment incentives for good outcomes, you run the risk of patient selection, discrimination, and fraud. My favorite paper on this topic comes from the British NHS, and their attempt to reward physicians based on better clinical outcomes. My advice with this paper (and with most papers frankly) is to ignore what the authors say about their data (and the amazing success of their program!) and just look at the data for yourself. What they found with rewarding physicians based on health metrics was that doctors that treated the young, healthy, and rich did well, those with more patients, poorer patients, and older patients did more poorly. Finally, physicians that filed lots of “exception reports” to eliminate all their poorly-performing patients did great (yay, fraud!).

Metrics are good for identifying problems, but the mistake is the assumption that poor performance at a metric has everything to do with the physicians or the hospitals, or that slapping a penalty on poor performance will fix the problem. Sometimes, you’re studying society, not medical care. Incentive structures that put the burden on hospitals to take care of the most basic needs of their patients are going to penalize those hospitals that take care of the neediest, sickest, oldest patients, and reward those who treat insured, wealthy, younger, and fewer patients. Worse, if you penalize hospitals for taking care of difficult patient populations, I can predict the outcome. More bogus (and occasionally dangerous) transfers, more patients dumped on public and university hospitals, and all the other tricks of patient selection private hospitals can engage in to avoid getting stuck with the economic losses. That is, patients who are really sick, really poor, really old, and most in need of care will get transferred, obstructed, and dumped. Hospitals that are referral centers, major university and public hospitals that can’t refuse or transfer problem patients, will end up with the disproportionate amount of the penalties because they are often the healthcare providers of last resort. Not surprisingly, the early data already shows this is happening:

The second important development was the release of data on who will be penalized: two thirds of eligible U.S. hospitals were found to have readmission rates higher than the CMS models predicted, and each of these hospitals will receive a penalty. The number of hospitals penalized is much higher than most observers would have anticipated on the basis of CMS’s previous public reports, which identified less than 5% of hospitals as outliers. In addition, there is now convincing evidence that safety-net institutions (see graphsProportion of Hospitals Facing No Readmissions Penalty (Panel A) and Median Amount of Penalty (Panel B), According to the Proportion of Hospital’s Patients Who Receive Supplemental Security Income.), as well large teaching hospitals, which provide a substantial proportion of the care for patients with complex medical problems, are far more likely to be penalized under the HRRP.3 Left unchecked, the HRRP has the potential to exacerbate disparities in care and create disincentives to providing care for patients who are particularly ill or who have complex health needs, particularly if the penalties are larger than hospitals’ margins for caring for these patients.

It would be unfortunate if in the course of creating incentives for better care, we fall into the same old trap of punishing those who take care of the neediest. What we need instead is to acknowledge one major source of bad outcomes is a broken social-safety net. We can’t just keep creating these unfunded mandates that put all the onus of taking care of the uninsured, the poor and elderly on hospitals, and punish the centers that already carry the largest social burdens with responsibility for the failure of our nation to take care of its own. Unfortunately, our answer to problems like these is always to create one more shell game that hides the real, unavoidable costs of taking care of people by shifting it around. This will just result in higher bills on the insured, more crazy chargemaster fees, overburdened public and university hospitals, and ultimately, a system of regressive taxation.

New homebirth statistics show it's way too dangerous, and Mike Shermer on liberal denialism

Two links today for denialism blog readers, both are pretty thought provoking. The first, from Amy Tuteur, on the newly-released statistics on homebirth in Oregon. It seems that her crusade to have the midwives share their mortality data is justified, as when they were forced to release this data in Oregon, planned homebirth was about 7-10 times more likely to result in neonatal mortality than planned hospital birth.

I’m sure Tuteur won’t mind me stealing her figure and showing it here (original source of data is Judith Rooks testimony):

Oregon homebirth neonatal mortality statistics, from the Skeptical OB.

Armed with data such as these, it needs to become a point of discussion for both obstetricians and midwives that out of hospital births have a dramatically-higher neonatal mortality, and this is worse for midwives without nursing training (the DEM or direct-entry-midwives). It’s their body and their decision, but this information should be crucial to informing women as to whether or not they should take this risk. It also is only a reflection of neonatal mortality, one could also assume it speaks to higher rates of morbidity as well, as longer distances and poorer recognition of fetal distress and complications will lead to worse outcomes when the child survives. It should be noted this data is also consistent with nationwide CDC data on homebirth DEMs, and actually better than midwife data for some states like Colorado.

The second article worth pointing out today (even though it’s old) is from Michael Shermer in Scientific American on the liberal war on science. Regular readers know that I’m of the belief there isn’t really a difference between left and right-wing ideology on acceptance of science, it just means they just reject different findings that collide with their ideology.

The left’s war on science begins with the stats cited above: 41 percent of Democrats are young Earth creationists, and 19 percent doubt that Earth is getting warmer. These numbers do not exactly bolster the common belief that liberals are the people of the science book. In addition, consider “cognitive creationists”—whom I define as those who accept the theory of evolution for the human body but not the brain. As Harvard University psychologist Steven Pinker documents in his 2002 book The Blank Slate (Viking), belief in the mind as a tabula rasa shaped almost entirely by culture has been mostly the mantra of liberal intellectuals, who in the 1980s and 1990s led an all-out assault against evolutionary psychology via such Orwellian-named far-left groups as Science for the People, for proffering the now uncontroversial idea that human thought and behavior are at least partially the result of our evolutionary past.

There is more, and recent, antiscience fare from far-left progressives, documented in the 2012 book Science Left Behind (PublicAffairs) by science journalists Alex B. Berezow and Hank Campbell, who note that “if it is true that conservatives have declared a war on science, then progressives have declared Armageddon.” On energy issues, for example, the authors contend that progressive liberals tend to be antinuclear because of the waste-disposal problem, anti–fossil fuels because of global warming, antihydroelectric because dams disrupt river ecosystems, and anti–wind power because of avian fatalities. The underlying current is “everything natural is good” and “everything unnatural is bad.”

Whereas conservatives obsess over the purity and sanctity of sex, the left’s sacred values seem fixated on the environment, leading to an almost religious fervor over the purity and sanctity of air, water and especially food.

I’m worried that Shermer has confused liberal Luddism with denialism, and I would argue some anti-technology skepticism is healthy and warranted. While I agree that the anti-GMO movement does delve into denialist waters with regularity, these are not good examples he has chosen. One needs to be cautious with technology, and it’s a faith-based assumption that technology can solve all ills. I’m with Evgeny Morozov on this one, the assumption there is (or should be) a technological fix for every problem has become almost a religious belief system. Appropriately including the potential perils of a technology in its cost-benefit analysis is not a sign of being anti-science. Even overblowing specific risks because of individual values isn’t really anti-science either. It might be anti-human to put birds before human needs as with wind turbines, but no one is denying that wind turbines generate electricity. And while liberals may be overestimating the risk of say, nuclear waste generation over carbon waste generation (guess which is a planet-wide problem!), it doesn’t mean they don’t think nuclear power works or is real. They just have an arguably-skewed risk perception, which is an established problem in cases of ideological conflict with science or technology. There is also reasonable debate to be had over the business-practices of corporations (Monsanto in his example), which need and deserve strong citizen push-back and regulation to prevent anti-competitive or abusive behavior.

Anti-science requires the specific rejection of data, the scientific method, or strongly-supported scientific theory due to an ideological conflict, not because one possesses superior data or new information. I don’t think Shermer actually listed very good examples of this among liberals. If you’re going to talk about GMO denialism, don’t complain about people fighting with Monsanto, talk about how anti-GMO advocates make up crazy claims about the foods (see natural news for example) such as that they cause autism, or cancer. And even then it’s difficult to truly say this is a completely liberal form of denialism as Kahan’s work shows again, there is a pretty split ideological divide on GMO.

I agree that liberals are susceptible to anti-science and the mechanism is the same – ideological conflict with scientific results. However, the liberal tendency towards skepticism of technology is healthy in moderation, and anti-corporatism is not automatically anti-science. In an essay that was striving to say we must be less ideological and more pragmatic, Shermer has wrongly lumped in technological skepticism, and anti-corporatism with science denial.

Bittman changes his tune on Sugar Study, while Mother Jones Doubles Down

There’s been an interesting edit in Marc Bittman’s sugar post, as he has now changed his tune on the PLoS one sugar study, now Bittman acknowledges obesity too is important. That was big of him, it is after all, the most important factor. Maybe my angry letter to the editor had an effect, but he’s grudgingly changed this statement:

In other words, according to this study, obesity doesn’t cause diabetes: sugar does.

To:

In other words, according to this study, it’s not just obesity that can cause diabetes: sugar can cause it, too, irrespective of obesity. And obesity does not always lead to diabetes.

The second sentence is totally unnecessary. Of course obesity doesn’t always cause diabetes, or heart attack or whatever. Nor do cigarettes always cause lung cancer. Nor does sugar intake always lead to obesity or diabetes. But obesity is the primary cause of type two diabetes, just as cigarettes are the primary cause of lung cancer, and who knows what sugar is doing.

Mother Jones, sadly, has decided to double down, calling the PLoS One study the “Best. Diet. Study. Ever.” It’s not, of course. It’s merely interesting and suggestive of an effect. It is not nearly proof of causation. They also laud the Mediterranean diet study (maybe it was supposed to be the Best. Study. Ever.?), however, they again show they’re not actually reading these papers because if you read our coverage of the study you’d know they didn’t actually study the Mediterranean diet! In a case of the blind leading the blind, they quote Bittman’s misinformed piece on the Mediterranean diet study

Let’s cut to the chase: The diet that seems so valuable is our old friend the “Mediterranean” diet (not that many Mediterraneans actually eat this way). It’s as straightforward as it is un-American: low in red meat, low in sugar and hyperprocessed carbs, low in junk. High in just about everything else — healthful fat (especially olive oil), vegetables, fruits, legumes and what the people who designed the diet determined to be beneficial, or at least less-harmful, animal products; in this case fish, eggs and low-fat dairy.

This is real food, delicious food, mostly easy-to-make food. You can eat this way without guilt and be happy and healthy. Unless you’re committed to a diet big on junk and red meat, or you don’t like to cook, there is little downside

Except for one critical fact. The subjects assigned to the Mediterranean diet did not have lower consumption of red meat, sugar and hyperprocessed carbs, or other junk! If you look at the supplementary data, you see that the subjects took the positive recommendations of the diet (olive oil, nuts, fish), and more or less ignored the negative recommendations (less meat, less spreadable fats/butter, less baked goods). If you look at figures like supplementary S6, the study groups did not change their diets in these categories relative to the controls, so the effects on their cardiovascular events relative to controls aren’t likely to be from the diet recommendations. When there were changes relative to baseline, even when statistically significant, the changes were tiny.

The participants in this study actually had a very high fat intake, about 35-40% of calories across all groups. And while there was a statistically-significant decrease in cardiovascular events like stroke and heart attack in both study groups (Med + olive oil, Med + nuts), only one arm of the so-called Mediterranean diet (Med + Olive oil) had a non-significant decrease in mortality, while the other arm (Med + Nuts) had a similar curve compared to the “do nothing” control. My interpretation of this, and it’s fine to be critical of it, is that this isn’t that meaningful. If anything, the only variable correlating with decrease in mortality was excess olive oil consumption (> 4 tbsp/day), not the Mediterranean diet. Either that, or eating nuts cancels out the beneficial effects of the diet on mortality.

This is why people always dump on nutrition science when it appears to change every 10 years. Results get overblown, and when the inevitable regression towards the mean occurs, we get blamed for it. The reality is, the press coverage of science is extremely poor, and there is not adequate critical analysis and presentation of results to their audience.

Don't Switch to the Mediterranean Diet Just Yet

The New York Times made big news with reports that the New England Journal of Medicine study on the beneficial effects of the Mediterranean diet showed it could dramatically reduce the rates of heart attack and stroke. But this study has major issues that bear directly on whether or not physicians should make new recommendations about dietary intake of fats like olive oil, or whether patients should adopt the diet as a whole. Let’s talk about the trial.

First of all, this is a randomized, controlled trial, in which 7447 men and women between 55 and 80 years of age who had major risk factors for cardiovascular disease such as diabetes, obesity, smoking, hyperlipidemia etc., were divided evenly between 3 groups, one which received recommendations on a “low fat” diet, and two in which there was extensive counseling on the Mediterranean combined with either a ready free supply of extra-virgin olive oil, or alternatively a variety of nuts.

The primary end points being studied was the combined number of heart attacks, strokes, and death, and over the course of about 5 years of study about 288 such events occurred. If you combine all three of these end points together, and evaluate their frequency between the groups you find 96 of these end points occurred in the “Mediterranean diet with extra-virgin olive oil” or 3.8% of the group, 83 occurred in the Mediterranean diet with nuts for 3.4% of that population, and 109 in the control group for 4.4% of the controls.

But before anyone takes these results to heart, we have to recognize major flaws with the study design, and the populations that comprised these three groups. First, the rate of primary events was surprisingly low for such a high risk group, and because the study was stopped early, absurdly for “ethical reasons”, the number of events is quite low. For the life of me I can’t think of what that ethics committee was thinking. These results are not that dramatic. Further, the “low fat” diet was very ineffectually enforced or counseled, to the point that midway through the study the authors revised the protocol to include more counseling sessions. Evaluating the supplementary data, specifically table S7, you see this control group was in no way on a low fat diet. They still were consuming 37-39% of their calories from fat! “Low fat” should have 10-15% of calories from fats, so basically, everyone ignored the diet. Further, all of the groups consumed a similar amount of total fat, mono and poly-unsaturated fats, and even a used olive oil as their main culinary fat. All groups consumed (see table S5) a similar amount of red meat (forbidden from all diets), butter, soda, baked goods, etc. The places where there seemed to be more dramatic differences were in olive oil consumption (about 50% of controls had > 4 tbsp a day, vs 80% of the “nuts” group and about 90% of the “extra-virgin olive oil group), wine consumption (modest at about 30% in diet groups vs 25% in “low fat” control), nuts (crazy high at 90% in nuts group, vs 40% and 20% in “olive oil” and “low fat”, as well as modest elevation of the amount of fish, fruits and vegetables in the Mediterranean groups. Further, some of these differences, such as the consumption of alcohol, fruits and vegetables, was higher in the Mediterranean groups at baseline (notice no mean change in table S6) so the groups may have started out in a different place.

What does this mean? First of all, we have to reject the notion that this study compared Mediterranean diet to “low fat” diet. This was a study of basically no diet intervention versus increasing your intake of fish, nuts and/or olive oil. Otherwise, there didn’t appear to be compliance with the negative suggestions of the Mediterranean diet, to decrease red mean intake, baked goods, dairy, etc. The participants basically took the recommended items and increased them in their diets, but didn’t exclude any of the “discouraged” items. This is very interesting, but to call it the “Mediterranean diet” is misleading. In reality, it’s diet supplementation with olive oil, nuts and fish.

Second, the final results, while they sound impressive (30% reduction in combined primary end points!) are actually not as important as some of the less-emphasized findings. For this we have to evaluate the secondary endpoint, which happens to be the one we really care about – all cause mortality. They could not show a difference in mortality! So while you might be less likely to have a heart attack or stroke, you’re no less likely to die. This is why I’m so confused they ended the study early. This is really the only end point that matters, and it was unchanged at the interval at which the ethics committee decided this study had to be stopped for efficacy. Why did they do this? The evidence is suggestive that with more participants, the Mediterranean diet + olive oil might have diverged a bit and shown a benefit compared to the do nothing “low fat” control, but this didn’t reach significance.

What have we learned? Compared to other Spanish folks between the ages of 55 and 80, all with cardiovascular risk factors, those that added olive oil, nuts, and fish to their diet had fewer cardiovascular events, but no difference in their mortality compared with people that did nothing to change their diet.

Why did this make the front page of the New York Times? Let’s show a little bit more critical analysis of findings, and not just swallow the PR.

No, It's Not the Sugar – Bittman and MotherJones have overinterpreted another study

Diet seems to be all over the New York Times this week, with an oversell of the benefits of the Mediterranean diet, and now Mark Bittman, everyone’s favorite food scold, declaring sugar is the culprit for rising diabetes. His article is based on this interesting new article in PLoS One and begins with this wildly-inaccurate summary:

Sugar is indeed toxic. It may not be the only problem with the Standard American Diet, but it’s fast becoming clear that it’s the major one.

A study published in the Feb. 27 issue of the journal PLoS One links increased consumption of sugar with increased rates of diabetes by examining the data on sugar availability and the rate of diabetes in 175 countries over the past decade. And after accounting for many other factors, the researchers found that increased sugar in a population’s food supply was linked to higher diabetes rates independent of rates of obesity.

In other words, according to this study, obesity doesn’t cause diabetes: sugar does.

No! Not even close. I hate to repeat his misstatement, because I’d hate to reinforce this as a new myth, but it’s critical to see his full mistake here. This is a wildly inaccurate summary of the authors’ findings, and one they don’t even endorse in their discussion. Bittman has actually just said “obesity doesn’t cause diabetes”, and now has proven himself a deluded fool.

Let’s talk about this paper. This is what is called an “ecological study”, which means it studies populations as a whole, rather than individual patients. Using data from the United Nations Food and Agricultural Organization, the International Diabetes Federation, and various economic indicators from the World Bank, the authors compared populations of whole countries, in particular the prevalence of diabetes correlated to other factors such as GDP, urbanization, age, obesity, and availability of certain varieties of food like sugar, meat, fibers, cereals and oil. Using the rise, or fall, of diabetes prevalence over the last decade in various countries, they correlated this increase with increasing availability of sugar, obesity, urbanization, aging populations etc., and found a few interesting things. For one, increases in GDP, overweight and obesity, tracked significantly with increasing diabetes prevalence. But interestingly, when those factors were controlled for, increasing availability of sugar also tracked linearly with increasing diabetes prevalence, and the longer the duration of the exposure, the worse it got.

However, this does not mean that “obesity doesn’t cause” diabetes, if anything, it’s further support for the exact opposite. While a correlative study can’t be a “smoking gun” for anything, the data in this paper supports increasing modernization/GDP, obesity, and sugar availability are all correlated with higher diabetes prevalence. Even if the sugar relationship is causal, which is no guarantee, the increase in sugar availability could only explain 1/4 of the increase in diabetes prevalence. Obesity is still the main cause of diabetes, which can be demonstrated on an individual level by increases in weight resulting in loss of glycemic control, and subsequent weight loss results in return of euglycemia. In particular, the results of studies of bariatric surgery, in both restrictive and bypass procedures, weight loss is accompanied by improvement in diabetes. The attempts of toxin paranoids like Bittman to reclassify sugar as a diabetes-causing agent, and to dismiss obesity as a cause, are highly premature.

Mother Jones, has a slightly more balanced read, but it still oversells the results.

This is a correlation, of course, and correlation does not always equal causation. On the other hand, it’s an exceptionally strong correlation.

Well, that’s another overstatement. Want to see a picture?

http://www.plosone.org/article/fetchObject.action?uri=info:doi/10.1371/journal.pone.0057873.g002&representation=PNG_M

Article Source: The Relationship of Sugar to Population-Level Diabetes Prevalence: An Econometric Analysis of Repeated Cross-Sectional Data

Basu S, Yoffe P, Hills N, Lustig RH (2013) The Relationship of Sugar to Population-Level Diabetes Prevalence: An Econometric Analysis of Repeated Cross-Sectional Data. PLoS ONE 8(2): e57873. doi:10.1371/journal.pone.0057873

Figure 2. Adjusted association of sugar availability (kcal/person/day) with diabetes prevalence (% adults 20–79 years old).

I wonder what the R-squared is on that line fit. Now, consider a comparison with obesity rates by diabetes prevalence:

Figure 1. Relationship between obesity and diabetes prevalence rates worldwide.

Obesity prevalence is defined as the percentage of the population aged 15 to 100 years old with body mass index greater than or equal to 30 kg/meters squared, from the World Health Organization Global Infobase 2012 edition. Diabetes prevalence is defined as the percentage of the population aged 20 to 79 years old with diabetes, from the International Diabetes Federation Diabetes Atlas 2011 edition. Three-letter codes are ISO standard codes for country names.
doi:10.1371/journal.pone.0057873.g001

Hmm, they didn’t fit a line here, but I can bet the fit would be better. Diabetes strongly correlates with BMI, this has been shown time and again using national survey data like NHANES or SHIELD. And before people start whining about BMI as an imperfect measure of obesity, it is perfectly appropriate for studies at a population level, and other metrics such as waist size, hip/waist ratios etc., all show the same thing. Diabetes risk increases linearly with BMI, with as many as 30% of people with BMI > 40 having diabetes, and further, we know from cohort and interventional studies that weight loss results in decreased diabetes. Much of this data is correlative as well (with the exception of the weight-loss studies), and the study that would prove this for certain – dividing people into diets providing excess fat, vs sugar, vs mixed calories, vs controls, with resultant measurement of diabetes rates, would be unethical. Either way, declaring sugar the enemy is both incomplete, and premature. While this paper provides interesting correlative evidence for increased sugar availability increasing diabetes prevalence, it is still subject to risk of confounding errors, it is correlative, and the link does not explain away other known causes of type II diabetes such as obesity. It is a warning however, and we should dedicate more study towards determining if sugar consumption (rather than mere availability) is an independent risk factor for type II diabetes.

Bittman has wildly overstated the case made by this article. He should retract his claims, and the title and false claims should be corrected by the editors. This is a terrible misrepresentation of what this study shows.

Dr. Oz is an increasingly dangerous promoter of denialism and quackery

I’m very disturbed to see the amount of exposure that Dr. Oz has credulously given to gay conversion therapy quacks. Via Ed I read Warren Throckmorton’s coverage of the disaster on Oz’s show, with the reversion therapists lying and contradicting their own previous statements about the therapy, what it accomplishes, and their philosophy of sexual orientation. Worse, those brought on to counter the misinformation were given no time to address all the falsehoods, all the while the gay conversion therapy quacks were represented as being of equivalent expertise.

It’s unfortunate that even as we’re seeing success in having gay conversion therapy banned as quackery in some states, professional cranks like Oz are undermining the process of educating people about homosexuality. Homosexuality is not a disorder, has not been considered such by legitimate professionals for almost 40 years now, and does not need treatment. It is also not the fault of the parents, the individual, or a moral failing. Attempts to “repair” people that are homosexual have been studied, they are unsuccessful and only cause harm. It is a sign of progress that California is taking steps to ban this therapy in regards to minors as forcing quackery on those who can not protect themselves from it. Reversion therapy is not legitimate medical therapy and is harmful. As stated in the CNN article:

But the psychiatric organization [the APA] — which is the world’s largest of its kind, with more than 36,000 members — determined, in fact, that reparative therapy poses a great risk, including increasing the likelihood or severity of depression, anxiety and self-destructive behavior for those undergoing therapy. Therapists’ alignment with societal prejudices against homosexuality may reinforce self-hatred already felt by patients, the association says.

“The longstanding consensus of the behavioral and social sciences and the health and mental health professions is that homosexuality per se is a normal and positive variation of human sexual orientation,” the association says.

We know that the lack of acceptance of a child who is homosexual puts the child at much greater risk of depression, other mental illness and suicide.

We should heed ERV’s warning, do not go on the Dr. Oz show, even if you think it’s to set the record straight. He won’t give fair time to the actual credible scientists or experts, he’ll just trot out the psychics, and quacks, and frauds, and maybe allow a soundbite at the end to contradict an entire hour of misinformation.

This might represent a truism in general about professionals on television. Television is entertainment, and the need to entertain routinely contaminates the delivery of factual information. Oz might have started with some actual legitimacy, but the need to put on a show, day after day, eventually will compromise your ability to maintain standards of professionalism. Oz has now sunk so low as to be irredeemable. This is homophobia disguised as medicine, and it is despicable for a medical professional to promote it uncritically on television.

Abortion can be lifesaving

While I realize Joe Walsh lost his election bid, it is still worth emphasizing that his infamous statements about abortion are false, especially considering efforts like those in Ohio to pass a “heartbeat bill”. Abortion is sometimes necessary to save the life of the mother. Via the Irish Times we hear the sad story of a woman being allowed to get sicker and sicker, while a non-viable but “living” fetus kills her.

“The doctor told us the cervix was fully dilated, amniotic fluid was leaking and unfortunately the baby wouldn’t survive.” The doctor, he says, said it should be over in a few hours. There followed three days, he says, of the foetal heartbeat being checked several times a day.

“Savita was really in agony. She was very upset, but she accepted she was losing the baby. When the consultant came on the ward rounds on Monday morning Savita asked if they could not save the baby could they induce to end the pregnancy. The consultant said, ‘As long as there is a foetal heartbeat we can’t do anything’.

“Again on Tuesday morning, the ward rounds and the same discussion. The consultant said it was the law, that this is a Catholic country. Savita [a Hindu] said: ‘I am neither Irish nor Catholic’ but they said there was nothing they could do.

At this point the story is mostly upsetting because of the pain and distress the patient was undergoing for a nonviable fetus. But in the next sentence the story goes from describing mere horrific, dangerous medical care and patient abuse to total medical incompetence and wrongful death:

“That evening she developed shakes and shivering and she was vomiting. She went to use the toilet and she collapsed. There were big alarms and a doctor took bloods and started her on antibiotics.

If this timeline is correct, this sounds like “rigors”, a classic sign of impending sepsis. Her collapse is concerning for impending septic shock. One of the most important factors in preventing worsening sepsis after infection, per the Surviving Sepsis guidelines, is source control. That is, if there is a source for the sepsis – a foreign body, and infected wound, etc., it needs to be removed/drained so that the condition doesn’t worsen. This, in addition to being common sense, is medically imperative to prevent the worsening of symptoms.

However, for the sake of a non-viable fetus in the midst of a miscarriage, source control was ignored, and the patient proceeded to worsen and die.

At lunchtime the foetal heart had stopped and Ms Halappanavar was brought to theatre to have the womb contents removed. “When she came out she was talking okay but she was very sick. That’s the last time I spoke to her.”

At 11 pm he got a call from the hospital. “They said they were shifting her to intensive care. Her heart and pulse were low, her temperature was high. She was sedated and critical but stable. She stayed stable on Friday but by 7pm on Saturday they said her heart, kidneys and liver weren’t functioning. She was critically ill. That night, we lost her.”

This appears to be death from a critical delay in source control, in the face of septic shock. Removal of the fetus should have occurred emergently when she presented with signs and symptoms of sepsis in order to save her life. This was not done, and she almost certainly died as a result of this delay.

Maternal mortality in pregnancy is very rare thanks to modern medicine. However, when ideology trumps medically-appropriate care we turn back the clock to when women died routinely in childbirth.

Dr. Amy Tuteur calls out the homebirth movement for denialism

I’ve been lurking at the Skeptical OB for a while and enjoying Amy Tuteur’s very effective criticism of some of the extremes of the homebirth movement. I had noticed that among some advocates of homebirth that were proposing risky behavior for pregnant mom’s that conflict with the literature that it appears to be a movement rife with denialists who promote the valorization of ignorance in Dr. Tuteur’s words. Mostly their problems seem to be with accepting there is a real, measureable increase in risk with homebirth, and rejecting the very real health benefits that medical physicans offer in preventing fetal and maternal mortality. She summarizes the argument for homebirth-advocacy-as-denialism here and my heart was warmed that she used our 5 criteria for identifying denialist argumentation.

I’ll also point out she has some really compelling posts I’ve read in the last few weeks that are worth a look for anyone who is considering homebirth using a CPM rather than an OB/Gyn. See:

Humbled by Birth
Latest in homebirth deaths plus a near miss
Homebirth midwife requirements “tightened” to include high school diploma
Yes it is your fault that your baby died at homebirth
and
even more homebirth deaths– in particular I was jumping up and down angry when I read about people describing their childrens deaths from group B strep! What the hell! This is imminently preventable, treatable, and such an example of an obvious preventable death I nearly fell out of my chair.

Dr. Tuteur does an excellent job of providing compelling data, experience, and examples of why this movement is bad for mothers and bad for babies. Denialism can kill. There are very real advantages to appropriate prenatal screening and testing offered by OB’s, and very real problems that can occur even with “low risk” births that may result in the death of an infant or the mother. People can argue about homebirth and rejecting medicine as a choice, but you can’t argue that this is risky behavior that is resulting in preventable deaths. The idea that a high-school dropout with a CPM certification (requiring passing a test and attending a handful of births) can offer the same level of experience and safety as an OB/GYN that has training in hundreds of deliveries, is a medical doctor, can perform prenatal risk assessment and screening, and has the ability to surgically rescue in an emergency is ludicrous. In my very limited OB experience as a medical student I’ve seen “low risk” go to “potential disaster” and the life of the baby and possibly the mother be saved by interventions as simple as fetal heart monitoring and ready access to an operating suite. These stories of people being in labor for 48 hours and delivering dead infants are very distressing because we can avoid this! It’s like choosing non-sterile surgery over anti-septic surgery because bacteria are natural. Why ignore decades of research, experience and the obvious improvement in perinatal and maternal mortality that obstetrics has provided over the last century?