What beans are you cooking today? These are my pinto beans. pic.twitter.com/yEPcu5VVLp
— Bix (@BixWeber) December 17, 2018
Diabetes is an expensive disease, both for society and for the individual. For the individual:
People with diagnosed diabetes incur average medical expenditures of ∼$16,750 per year, of which ∼$9,600 is attributed to diabetes. People with diagnosed diabetes, on average, have medical expenditures ∼2.3 times higher than what expenditures would be in the absence of diabetes.
– Economic Costs of Diabetes in the U.S. in 2017, Diabetes Care, May 2018
$10,000/year, just for your diabetes, not any other disease you may have. Some of that can be covered by insurance. Still, there are copays, coinsurances, deductibles (a $5000 deductible is ludicrous), out-of-network costs.
Why is diabetes costly? Because it impacts just about every system in the body, and because it requires ongoing care, likely for the rest of your life. Some things you buy when you have diabetes:
- Drugs (metformin and sulfonylureas to start then the more costly DDP4 inhibitors up to crazy-costly insulin).
- Healthcare visits and treatments (you’re supposed to see, besides a general practitioner, a diabetes educator, dietitian, endocrinologist, foot doctor, eye doctor, cardiologist, maybe kidney specialist, maybe mental health specialist, all at least yearly. Our patients complained that not a month went by that they weren’t in a doctors office.)
- Supplies and devices (meters, strips, lancets, syringes, monitors, pumps, special glasses, stockings, shoes, and over-the-counter drugs like Advil and antacids because diabetes makes your body ache/neuropathy and your stomach hurt/gastroparesis).
Before the Affordable Care Act (ACA also know as Obamacare) insurers could deny people with diabetes a policy, reject them outright, because they had a pre-existing condition. (Also … Did you have a stroke? Heart attack? Cancer? No policy for you!) Obamacare made that illegal. Trump campaigned on getting rid of Obamacare, getting rid of these protections for pre-existing conditions. It was a focal point of his campaign. People carried anti-Obamacare signs. Millions of people voted for Trump in the hopes he would abolish it. It looks like they may get their wish. A federal judge in Texas ruled that a provision of Obamacare is unconstitutional, so the whole thing would go away. I think I get why Republicans are so against protections for pre-existing conditions. It means insurers can go back to denying people coverage, increasing both their bottom lines and the pockets of those who invest in them.
While much of the cost of diabetes appears to fall on insurers (especially Medicare) and employers (in the form of reduced productivity at work, missed work days, and higher employer expenditures for health care), in reality such costs are passed along to all of society in the form of higher insurance premiums and taxes, reduced earnings, and reduced standard of living.
It behooves us, as a society, to care. To make default choices the healthiest choices. To improve school lunches so children have a leg up on their health. To study and then regulate the hundreds of chemicals that act as endocrine disruptors (EDs). To reduce pollution. To design safe walking paths in cities. To offer affordable housing. To reduce wealth inequality. To subsidize not just commodity crops like corn and soy, but fruits and vegetables, so more people can access them. To apply the standards of organic farming to all food crops (because pesticides act as endocrine disruptors and EDs have been shown to increase risk for diabetes). All of these things, and more!, would reduce the incidence of diabetes.
I’m so happy to see this.
Finding the Balance Between Benefits and Harms When Using Statins for Primary Prevention of Cardiovascular Disease: A Modeling Study, Annals Of Internal Medicine, 4 December 2018
A study published Monday is pushing back against the notion that up to 40 percent of Americans should be taking statin drugs to reduce the risk of heart disease. The study … argues that current medical guidelines haven’t adequately considered the risks from these widely used drugs.
“Some harms are mentioned, but it’s entirely unclear how they were considered when coming up with the recommendations,” says Milo Puhan, a physician and epidemiologist at the University of Zurich and senior author of the new study. “In our approach we very explicitly considered the harms.”
Anywhere from 50 to 200 healthy people need to take a statin daily to prevent a single heart attack for five years, so even small harms may outweigh the potential benefits, the Swiss scientists say.
The most common side effect of these drugs is muscle pain, which usually goes away if patients stop taking the medicines. People taking statins are also at a higher risk of developing diabetes, which is harder to reverse.
He also finds that benefits fade compared with harms as people get older. “The elderly do not benefit as much as previous studies might have thought,” he says.
“One size doesn’t fit it all,” he concludes. “That’s a very important message.”
Puhan says, based on his assessment, perhaps 15 to 20 percent of older adults should be taking statins – far less than the 30 or 40 percent suggested by current medical guidelines.
“I think for me, as a physician,” says Ilana Richman, an internist at the Yale School of Medicine, “this kind of data suggests that if we give more weight to the potential for adverse events, then maybe it’s reasonable to hold off for lower-risk patients.”
She co-wrote an editorial about the paper and came away from it thinking that doctors need to spend more time talking about the plusses and minuses of statin treatment, personalizing their recommendations more than they do now. She says it’s a challenge to convey these sophisticated concepts in the short amount of time doctors have to spend with their patients.
Yet that kind of dialog is increasingly the expectation. In mid-November, the American Heart Association and American College of Cardiology published new guidelines calling for more nuanced conversations around who would most benefit from statins.
No one should be taking a drug or other therapy without a healthcare worker sitting down with them and discussing the risks and side effects. Sitting down with them and talking, not handing them a pamphlet. The decision to take a drug, ultimately, should be a made by the patient or their designated spokesperson. No patient should be coerced or ridiculed for their decision. This is called patient-centered care:
” … providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.”
I have to put this out there because I just saw another article, this one on NPR, that promotes the consumption of animal food – meat, dairy and eggs – to get enough protein. Vegans, it says, may need protein supplements! (The first is from a dietitian, the second from the article’s author.)
Vegans can benefit from protein supplements since they do not eat animal-based protein sources like meat, dairy or eggs.
Bottom line, if you think you need more protein in your diet, consider these questions: Are you are an extreme athlete; are you recovering from injury or surgery; or are you 60 years or older? If so, adding high protein foods like eggs and meat products to your diet can be beneficial.
These statements are not true. Vegans get enough protein without taking a protein supplement. People over 60 and athletes do not need to add animal foods to their diets to be healthy. Vegan diets are not inadequate. Not only are they adequate, they benefit the environment and reduce risk for many chronic diseases. It’s not me saying all this; it’s the group of people who certify dietitians:
Position of the Academy of Nutrition and Dietetics: Vegetarian Diets, Journal of the Academy of Nutrition and Dietetics, 2016
It is the position of the Academy of Nutrition and Dietetics that appropriately planned vegetarian, including vegan, diets are healthful, nutritionally adequate, and may provide health benefits for the prevention and treatment of certain diseases.
These diets are appropriate for all stages of the life cycle, including pregnancy, lactation, infancy, childhood, adolescence, older adulthood, and for athletes.
Plant-based diets are more environmentally sustainable than diets rich in animal products because they use fewer natural resources and are associated with much less environmental damage.
Vegetarians and vegans are at reduced risk of certain health conditions, including ischemic heart disease, type 2 diabetes, hypertension, certain types of cancer, and obesity. Low intake of saturated fat and high intakes of vegetables, fruits, whole grains, legumes, soy products, nuts, and seeds (all rich in fiber and phytochemicals) are characteristics of vegetarian and vegan diets that produce lower total and low-density lipoprotein cholesterol levels and better serum glucose control. These factors contribute to reduction of chronic disease.
Vegetarian, including vegan, diets typically meet or exceed recommended protein intakes, when caloric intakes are adequate.
Protein needs at all ages, including those for athletes, are well achieved by balanced vegetarian diets.
The misconception that plant-based diets lack adequate protein continues, even among educated, credentialed healthcare workers. It’s exasperating.
Right here in the prestigious and if I may say conservative Journal of the American Medical Association is an article challenging the practice of giving seasonal flu shots. How about that.
Officials and professional societies treat influenza as a major public health threat for which the annual vaccine offers a safe and effective solution. In this article, I challenge these basic assumptions. I show that there is no good evidence that vaccines reduce serious complications of influenza, the outcomes the policy is meant to address.
Moreover, promotional messages conflate “influenza” (disease caused by influenza viruses) with “flu” (a syndrome with many causes, of which influenza viruses appear to be a minor contributor). This lack of precision causes physicians and potential vaccine recipients to have unrealistic assumptions about the vaccine’s potential benefit, and impedes dissemination of the evidence on nonpharmaceutical interventions against respiratory diseases.
In addition, there are potential vaccine-related harms, as unexpected and serious adverse effects of influenza vaccines have occurred. I argue that decisions surrounding influenza vaccines need to include a discussion of these risks and benefits.
Nearly every influential professional society has endorsed the Centers for Disease Control and Prevention (CDC) recommendation of influenza vaccine for all people 6 months and older. Beyond reviewing the vaccines’ contraindications, why might a practicing physician want to do their own homework on the benefits and risks of influenza vaccines? The answer is that the disease is less fearful than advertised, the vaccines are less beneficial than believed, and the harms of vaccines are not easily dismissed.
First, influenza vaccines have a zero chance of benefitting most recipients, since the majority of Americans do not annually contract influenza. A recent Cochrane systematic review found that between 33 and 100 healthy adults would need to be vaccinated to avoid the onset of influenza symptoms in 1 individual.
Furthermore, decisions over influenza vaccination should be considered in the context of the likely case that the public assumes that so called flu shots are designed to prevent “flu” and its complications. However “flu,” better known as influenza-like illness, while arguably a very patient-centered and clinically relevant syndrome, has hundreds of known and unknown causes, of which influenza is just one. A reanalysis of the placebo and do-nothing arms of 88 vaccine studies suggested that the proportion of influenza-like illness caused by influenza is on average 7%. While promotional materials typically refer to influenza as “flu,” potential vaccine recipients should be educated about the distinction and its relevance to influenza vaccine performance against outcomes they wish to avoid.
Second, a key objective of influ enza vaccine campaigns today (and in decades past) is to reduce mortality or serious complications of influenza, particularly among the elderly population, in which most of the serious outcomes occur. However despite more than 50 years of recommended use in the elderly, it remains unclear if the vaccine can deliver those benefits. In the last 4 decades, just 1 randomized controlled trial has successfully assessed influenza vaccines in the elderly population living in the community, but only 10% of participants were 75 years or older, and the trial was underpowered to detect differences in hospitalization or mortality. Officials at the CDC have thus supported their policy by citing evidence from published, nonrandomized retrospective cohort studies, which have reported “large reductions in hospitalizations and deaths among the vaccinated elderly” – including a 48% reduction in all-cause mortality. The problem is that if such effects were real, the historical increase in vaccine uptake among the elderly population should readily have resulted in decreased total winter mortality, but it has not. As other researchers have demonstrated in studies that found similarly massive reductions in mortality, particularly during months when influenza was not circulating, and the CDC now acknowledges, the retrospective studies may be heavily confounded by healthy user bias(the tendency for healthier people to be more likely than less healthy people to get vaccinated. Given current poor vaccine performance, influenza does not deserve to be called a “vaccine-preventable disease.”
Third, evidence is lacking to support the expectation that vaccination of healthy health care workers will reduce the spread of influenza and its complications to particularly vulnerable elderly patients. While multiple published studies report impressive benefits in such scenarios (including 2 cited by the CDC in support of its recommendation of health care worker vaccination, a Cochrane review of these studies noted that their results defy logic: the vaccine appeared to reduce death from all causes but not death from influenza. The Cochrane reviewers judged the studies to be “at high risk of bias,” and concluded that there is “no evidence that only vaccinating healthcare workers prevents laboratory-proven influenza, pneumonia, and death from pneumonia in elderly residents in long-term care facilities.”
BETTER THAN NOTHING?
It is tempting to think that vaccination still represents an intervention whose benefit — even if smaller than thought and based on poor-quality evidence — is still better than nothing. Even among groups that have acknowledged the aforementioned facts I listed, many remain supportive of CDC’s universal vaccination policy. But this position necessarily makes light of potential vaccine-related harms.
Cochrane reviews have noted serious deficiencies in safety outcome reporting in published influenza vaccine trials, suggesting a lack of understanding of the true safety profile of influenza vaccines that hampers an ability to weigh potential benefits against harms. While Guillain-Barre Syndrome* has been the most widely discussed influenza vaccine-related harm following its dramatic appearance during the 1976 “swine flu” scare, it is not the only risk associated with influenza vaccine. In 2009, Australia suspended its universal vaccination program for children younger than 5 years because of a surge in febrile convulsions following vaccination (1 in 110 children). Also in 2009, cases of narcolepsy following vaccination in adolescents were reported in Finland and Sweden. Official inquiries into these events have confirmed influenza vaccine’s role in all 3 countries, with the precise biological mechanisms still not understood. In Canada, epidemiologic investigations indicate that persons who received a seasonal influenza vaccine in 2008 had an increased risk of acquiring “pandemic” H1N1 in 2009 (perhaps by inhibiting antibodies relevant to heterosubtypic immunity) — important considering H1N1 vaccine generally arrived past most epidemic peaks. These events received scant coverage in the American scientific and lay presses.
The adverse events of 2009 arguably only came to light because their incidence was approximately 10 times the background rate, and surveillance systems were heightened because of concerns over H1N1. We must always remember that influenza vaccines are biologics, and biologic manufacturing is messy, with risks of contamination far in excess of drug production. For biologics produced anew each year, these unfortunate events demonstrate that good past experience is not necessarily predictive of future vaccine safety.
Other researchers have reported that annual influenza vaccination hampers development of CD8 T-cell immunity in children.
At a societal level, successful public health campaigns are only possible (and ethical) with the cooperation and buy-in of the public they serve. But as current influenza vaccine campaigns are based on information asymmetries — in which the public’s understanding of potential vaccine benefit and potential harms is incompatible with the evidence — the public trust is risked by a continuation of the status quo.
THE GOOD NEWS
Lost amidst the hum of annual influenza vaccine campaigns is the basic fact that influenza vaccines target a disease that is, for most people, self-limiting. While unpleasant, today, tragedies are rare. And for those who wish to be proactive, systematic reviews of nonpharmaceutical interventions largely based on studies of severe acute respiratory syndrome — have shown impressive evidence that measures like handwashing and wearing masks and gowns reduce the incidence of respiratory diseases. Large head-to-head trials comparing vaccines against measures such as handwashing are needed.
To summarize, the evidence that influenza represents a threat of public health proportions is questionable, the evidence that influenza vaccines reduce important patient-centered outcomes such as mortality is unreliable, the assumption that past influenza vaccine safety is predictive of future experience is unsound, and nonpharmaceutical interventions to manage influenza-like illness exist.
* Guillain-Barre Syndrome – A condition in which the immune system attacks the nerves. Results in pain, weakness, and loss of function.
I did not know there was such an array of harms, documented harms, associated with the flu shot. What harms have occurred, are occurring, that are not documented? Why don’t healthcare workers who recommend the vaccine discuss the full extent of risks? Do they know them? Who is in charge of making sure they know them? My trust in the CDC has been ratcheted down a few notches.
Stressful but a rather touching ending.
I’ve been researching the history of the influenza vaccine, particularly its effectiveness. I have to tell you, I’m surprised and disturbed. I also have to tell you that I’m not an anti-vaxxer. I believe in vaccination. It eradicated smallpox. It has almost eradicated polio. Vaccination is good. That’s how I went into this.
On to my findings. All of the quotations below are from this analysis by Peter Doshi:
Trends in Recorded Influenza Mortality: United States, 1900–2004, American Journal of Public Health, May 2008
1. Deaths from influenza declined over the 20th century. That reduction occurred before widespread use of vaccination and has been attributed to improved living conditions after World War II.
Influenza death rates dropped sharply around the end of World War II (1944–1945).
Another thing you can see in this chart, besides the reduction in deaths after WWII is that there were lots of regular flu seasons that were worse than pandemics.
The inability of influenza vaccination to explain the clear downward trend in recorded influenza mortality during the 20th century suggests that these other factors* may play an important role in historical influenza epidemiology.
* Living conditions, public health measures, physiological status, and access to improved treatments (e.g., antibiotics and antiviral agents)
2. Lots of people (health professionals, researchers, you and I) have said, and continue to say, that it’s the flu when it isn’t, or when we don’t know.
For most of the 20th century, influenza continued to be reported on death certificates despite the absence of laboratory confirmation of influenza virus infection.
Between 1999 and 2001, there was positive confirmation of influenza virus for fewer than 10% of deaths recorded as caused by influenza.
It is plausible that many cases and deaths from other (i.e., noninfluenza) ILIs (influenza-like illnesses) are being misclassified as influenza, particularly when they occur during the winter season.
3. Remember in this post where I quoted Cochrane as saying that over 200 viruses cause influenza-like illness? Well, the CDC keeps track of them, some of them, but they are not inclined to make that information public:
Viral circulation data on influenza as well as other viruses such as respiratory syncytial virus and rhinovirus may be helpful in an analysis of influenza’s impact on mortality, because these viruses often co-circulate with influenza. The CDC maintains such historical viral circulation data through programs such as the National Respiratory and Enteric Virus Surveillance System. Two attempts were made to obtain such data for analysis; however, the CDC responded that such data are only provided on condition of co-authorship, which I refused.
4. A pandemic, which we have been trained to think is a death knell, may not cause any more deaths than the regular seasonal flu (as we saw in that chart above).
The considerable similarity in mortality seen in pandemic and non-pandemic influenza seasons challenges common beliefs about the severity of pandemic influenza.
Many nonpandemic seasons were more deadly than subsequent pandemics.
Pandemic years were difficult to distinguish from nonpandemic seasons.
5. This is notable.
In the 1918–1919 pandemic, which stands out for its high mortality rate, although perhaps 10% to 15% of deaths were attributed to acute respiratory distress syndrome, many if not most of fatal cases are believed to have occurred because of secondary bacterial complications. Had no other aspect of modern medicine but antibiotics been available in 1918, there seems good reason to believe that the severity of this pandemic would have been far reduced.
6. Here’s what I was looking for. Does the flu shot reduce flu deaths? Behold:
Historical influenza mortality data contain many relevant implications for influenza vaccination campaigns. The overall decline in influenza-attributed mortality over the 20th century cannot be the result of influenza vaccination, because vaccination did not become available until the 1940s and was not widely used until the late 1980s. This rapid decline, which commenced around the end of World War II, points to the possibility that social changes led to a change in the ecology of influenza viruses.
Recent research suggests that vaccination is an unlikely explanation of mortality trends. A 2005 US National Institutes of Health study of over 30 influenza seasons “could not correlate increasing vaccination coverage after 1980 with declining mortality rates in any age group.
One study concluded that “evidence from systematic reviews shows that inactivated vaccines have little or no effect on the effects measured.”
7. Yet, the CDC is upping the fear ante for some reason, along with that the high-octane campaign to get vaccinated.
The top jagged line in the chart below are the deaths CDC said we would experience from flu. The bottom line is what we actually experienced – considerably less than projected. How can there be such a discrepancy between these lines? Year after year?
Also note from the graphs in this post that vaccination took off in the early 1990s and by 2009 over 40% of adults had been vaccinated. But the line for deaths from influenza remains pretty steady.
8. Why the high death estimates?
It is also important to recognize that commercial interests may be inflating the perceived impact of influenza and other infectious “pandemics.”
Commercial interests! It’s hard not to be cynical.
I totally thought that the flu vaccine had been reducing deaths, a lot more than it is? I’m having a hard time reconciling this data with my preconceptions about the flu vaccine.