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  • Mold Toxins in Cereals, Herbs, Spices, and Wine | NutritionFacts.org

    Most crops are contaminated with fungal mycotoxins, but some foods are worse than others.

    Oats can be thought of as “uniquely nutritious.” One route by which they improve human health is by providing prebiotics that “increase the growth of beneficial gut microbiota.” There are all manner of oats, ranging from steel-cut oats to, even better, intact oat groats (their form before being cut), all the way down to highly processed cereals, like Honey Nut Cheerios.

    “Rolling crushes the grain, which may disrupt cell walls and damage starch granules, making them more available for digestion.” This is bad because we want the starch to make it all the way down to our colon to feed our good gut bacteria. Grinding oats into oat flour to make breakfast cereals is even worse. When you compare blood sugar and insulin responses, you can see significantly lower spikes with the more intact steel-cut oats, as shown below and at 0:54 in my video Ochratoxin in Certain Herbs, Spices, and Wine.

    What about ochratoxin? As seen here and at 1:01 in my video, oats are the leading source of dietary exposure to this mold contaminant, but they aren’t the only source.

    There is a global contamination of food crops with mycotoxins, with some experts estimating as much as 25% of the world’s crops being affected. That statistic is attributed to the Food and Agriculture Organization of the United Nations, but it turns out the stat is bogus. It isn’t 25%. Instead, it may be more like 60% to 80%. “The high occurrence is likely explained by a combination of the improved sensitivity of analytical [testing] methods and the impact of climate change.”

    Spices have been found to have some of the highest concentrations of mycotoxins, but because they are ingested in such small quantities, they aren’t considered to be a significant source. We can certainly do our part to minimize our risk, though. For instance, we should keep spices dry after opening sealed containers or packages.

    What about dried herbs? In “Mycotoxins in Plant-Based Dietary Supplements: Hidden Health Risk for Consumers,” researchers found that milk thistle–based supplements had the highest mycotoxin concentrations. It turns out that humid, wet weather is needed during milk thistle harvest, which is evidently why they get so moldy. “Considering the fact that milk thistle preparations are mainly used by people who suffer from liver disease,” such a high intake of compounds toxic to the liver may present some concern.

    Wine sourced from the United States also appears to have particularly high levels. In fact, the single highest level found to date around the world is in a U.S. wine, but there’s contamination in wine in general. In fact, some suggest that’s why we see such consistent levels in people’s blood—perhaps because a lot of people are regular wine drinkers.

    Ochratoxin is said to be a kidney toxin with immunosuppressive, birth defect–causing, and carcinogenic properties. So, what about ochratoxin decontamination in wine? That is, removing the toxin? Ideally, we’d try to prevent the contamination in the first place, but since this isn’t always practical, there is increased focus on finding effective methods of detoxification of mycotoxins already present in foods. This is where yeast enters as “a promising and friendly solution,” because the mycotoxins bind to the yeast cell wall. The thought is that we could strain out the yeast. Another approach is to eat something like nutritional yeast to prevent the absorption.

    It works in chickens. Give yeast along with aflatoxin (another mycotoxin), and the severity of the resulting disease is diminished. However, using something like nutritional yeast as a binder “depends on stability of the yeast-mycotoxin complex through the passage of the gastrointestinal tract.” We know yeasts can remove ochratoxin in foods, but we didn’t have a clue if it would work in the gut until 2016. Yeast was found to bind up to 44% of the ochratoxin, but, in actuality, it was probably closer to only about a third, since some of the bindings weren’t stable. So, if you’re trying to stay under the maximum daily intake and you drink a single glass of wine, even if your bar snack is popcorn seasoned with nutritional yeast, you’d still probably exceed the tolerable intake. But what does that mean? How bad is this ochratoxin? We’ll find out next.

    Doctor’s Note

    This is the second video in a four-part series on mold toxins. The first one was Ochratoxin in Breakfast Cereals.

    Stay tuned for Should We Be Concerned About the Effects of Ochratoxin? and Should We Be Concerned About Aflatoxin?. You can also check: Friday Favorites: Should We Be Concerned About Ochratoxin and Aflatoxin?.

    Michael Greger M.D. FACLM

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  • Cheap insulin pens will soon be available through state-backed deal, Newsom announces

    SACRAMENTO — Gov. Gavin Newsom on Thursday announced a plan to offer $11 insulin pens through the state’s pharmaceutical venture.

    Beginning Jan. 1, consumers can purchase a five-pack of pens for a suggested price of $55, according to the governor’s office. The packs will be available to California pharmacies for $45.

    California is the first state in the nation to sell its own brand of generic prescription drugs as Newsom and other state leaders seek ways to drive down rising healthcare costs.

    Insulin users without health insurance today can pay $400 for a small vial.

    Newsom, in a statement Thursday, said that Californians shouldn’t “ration insulin or go into debt to stay alive.”

    “California didn’t wait for the pharmaceutical industry to do the right thing — we took matters into our own hands,” Newsom said.

    Officials hope the drug will lower costs across the board, not just for the consumers ultimately picking up the drug. Major drug companies have also cut prices on insulin, but critics contend those cost savings are passed on to other consumers.

    Earlier this week, Newsom signed legislation, Senate Bill 40, capping insulin co-pays at $35 for the first time in California.

    “This law ensures no family will be forced to choose between buying insulin and putting food on the table in California again,” the bill’s author, Sen. Scott Wiener (D-San Francisco), said in a statement.

    Newsom, who vowed to be the “healthcare governor” during his campaign, in 2020 unveiled a proposal for California to make its own line of generic drugs.

    Three years later, he announced a $50-million contract with the nonprofit generic drugmaker Civica to produce insulin under the state’s own label.

    Earlier this year, the state began selling Naloxone, a medication that blocks the effects of opioids, at below market prices.

    Dakota Smith

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  • Should You Take Statins?  | NutritionFacts.org

    How can you calculate your own personal heart disease risk to help you determine if you should start on a cholesterol-lowering statin drug?

    The muscle-related side effects from cholesterol-lowering statins “are often severe enough for patients to stop taking the drug. Of course, these side effects could be coincidental or psychosomatic and have nothing to do with the drug,” given that many clinical trials show such side effects are rare. “It is also possible that previous clinical trials”—funded by the drug companies themselves—“under-recorded the side effects of statins.” The bottom line is that there’s an urgent need to establish the true incidence of statin side effects.

    “What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?” That’s the title of a journal article that reports that, even in trials funded by Big Pharma, “only a small minority of symptoms reported on statins are genuinely due to the statins,” and those taking statins are significantly more likely to develop type 2 diabetes than those randomized to placebo sugar pills. Why? We’re still not exactly sure, but statins may have the double-whammy effect of impairing insulin secretion from the pancreas while also diminishing insulin’s effectiveness by increasing insulin resistance.

    Even short-term use of statins may “approximately double the odds of developing diabetes and diabetic complications.” As shown below and at 1:49 in my video Who Should Take Statins?, fewer people develop diabetes and diabetic complications off statins over a period of about five years than those who do develop diabetes while on statins. “Of more concern, this increased risk persisted for at least 5 years after statin use stopped.”

    “In view of the overwhelming benefit of statins in the reduction of cardiovascular events,” the number one killer of men and women, any increase in risk of diabetes, our seventh leading cause of death, would be outweighed by any cardiovascular benefits, right? That’s a false dichotomy. We don’t have to choose between heart disease and diabetes. We can treat the cause of both with the same diet and lifestyle changes. The diet that can not only stop heart disease, but also reverse it, is the same one that can reverse type 2 diabetes. But what if, for whatever reason, you refuse to change your diet and lifestyle? In that case, what are the risks and benefits of starting statins? Don’t expect to get the full scoop from your doctor, as most seemed clueless about statins’ causal link with diabetes, so only a small fraction even bring it up with their patients.

    “Overall, in patients for whom statin treatment is recommended by current guidelines, the benefits greatly outweigh the risks.” But that’s for you to decide. Before we quantify exactly what the risks and benefits are, what exactly are the recommendations of current guidelines?

    How should you decide if a statin is right for you? “If you have a history of heart disease or stroke, taking a statin medication is recommended, without considering your cholesterol levels.” Period. Full stop. No discussion needed. “If you do not yet have any known cardiovascular disease,” then the decision should be based on calculating your own personal risk. If you know your cholesterol and blood pressure numbers, it’s easy to do that online with the American College of Cardiology risk estimator or the Framingham risk profiler.

    My favorite is the American College of Cardiology’s estimator because it gives you your current ten-year risk and also your lifetime risk. So, for a person with a 5.8 percent risk of having a heart attack or stroke within the next decade, if they don’t clean up their act, that lifetime risk jumps to 46 percent, nearly a flip of the coin. If they improved their cholesterol and blood pressure, though, they could reduce that risk by more than tenfold, down to 3.9 percent, as shown below and at 4:11 in my video.

    Since the statin decision is based on your ten-year risk, what do you do with that number? As you can see here and at 4:48 in my video, under the current guidelines, if your ten-year risk is under 5 percent, then, unless there are extenuating circumstances, you should just stick to diet, exercise, and smoking cessation to bring down your numbers. In contrast, if your ten-year risk hits 20 percent, then the recommendation is to add a statin drug on top of making lifestyle modifications. Unless there are risk-enhancing factors, the tendency is to stick with lifestyle changes if risk is less than 7.5 percent and to move towards adding drugs if above 7.5 percent.

    Risk-enhancing factors that your doctor should take into account when helping you make the decision include a bad family history, really high LDL cholesterol, metabolic syndrome, chronic kidney or inflammatory conditions, or persistently high triglycerides, C-reactive protein, or LP(a). You can see the whole list here and at 4:54 in my video.

    If you’re still uncertain, guidelines suggest you consider getting a coronary artery calcium (CAC) score, but even though the radiation exposure from that test is relatively low these days, the U.S. Preventive Services Task Force has explicitly concluded that the current evidence is insufficient to conclude that the benefits outweigh the harms.

    Michael Greger M.D. FACLM

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  • Coloradans can get updated COVID vaccines, but insurance might not cover the shots

    Anyone 6 months and older who wants a COVID-19 shot in Colorado can now get one, but the vaccine will only be free for those with the right insurance — at least for now.

    Initially, pharmacies couldn’t administer the updated shots in Colorado unless a patient had a prescription. The state allows pharmacists to administer vaccines recommended by the Centers for Disease Control and Prevention’s advisory committee, but not other shots.

    Dr. Ned Calonge, chief medical officer for the state health department, responded by issuing a standing order — essentially, a prescription for every resident – allowing them to get vaccinated at retail pharmacies.

    But that order doesn’t guarantee insurance will cover the shots or that pharmacies will choose to stock them. Last year, fewer than half of people over 65 nationwide received an updated COVID-19 shot, with uptake dropping further in younger age groups, raising questions about whether health care providers will believe demand is high enough to justify buying the vaccine.

    “The standing order provides accessibility. It doesn’t necessarily provide availability,” Calonge said Tuesday.

    The Colorado Division of Insurance issued a draft rule last week that would require state-regulated plans to cover COVID-19 vaccines without out-of-pocket costs for people of any age, assuming the division passes it as written. Insurance cards from state-regulated plans typically have CO-DOI printed in the lower left corner.

    The state’s rule doesn’t apply to federally regulated plans, which account for about 30% of employer-sponsored insurance plans in Colorado, Calonge said. Typically, however, those plans try to offer competitive benefits, since they mostly serve large employers, he said.

    “My hope would be they would want to keep up with other insurers,” he said.

    This isn’t the first time that people on state-regulated plans have had benefits not guaranteed for people with federally regulated insurance.

    Colorado capped the cost of insulin and epinephrine shots to treat severe allergic reactions in state plans, but couldn’t require the same for plans the state doesn’t oversee. In those cases, it offered an “affordability program” requiring manufacturers to supply the medication at a lower cost for people who aren’t covered by the state caps, Medicare or Medicaid.

    At least two Colorado insurers surveyed by The Denver Post said all of their plans will cover COVID-19 vaccines, while others hedged.

    Select Health, which sells Medicare and individual marketplace plans in Colorado, said its plans currently cover COVID-19 vaccines without out-of-pocket costs for everyone. Kaiser Permanente Colorado said in a message to members that it will pay for the shot for anyone 6 months or older.

    Donna Lynne, CEO of Denver Health, said the health system’s insurance arm is waiting on clarification about when it should cover the vaccines. Denver Health Medical Plan offers multiple plan types, some state-regulated and some under federal rules, she said.

    “It’s less of a decision on our part than understanding what the health department and the insurance department are saying,” she said. “You can’t have one insurance company saying they are doing it and one saying they aren’t doing it.”

    Anthem said it considers immunizations “medically necessary” if the American Academy of Pediatrics, American Academy of Family Physicians or the CDC’s vaccine advisory committee has recommended them, but didn’t specify whether it would charge out-of-pocket costs for medically necessary vaccines.

    If those bodies stated that certain people could get a particular vaccine — but not that they should — Anthem would decide about coverage “on an individual basis,” its website said. The other groups have recommended the shots for people over 18 or under 2, with the option for healthy children in between to get a booster if their parents wish.

    The state’s Medicaid program is still waiting for guidance from federal authorities about whose vaccines it can cover, according to the Colorado Department of Health Care Policy and Financing, and Medicare isn’t yet paying for the shots.

    For most of the COVID-19 vaccines’ relatively brief existence, they were free and recommended for everyone 6 months and older. In 2024, the federal government stopped paying for them, which meant uninsured people no longer could be sure they could get the shot without paying.

    Almost all insurance plans still were required to pay for the shots, though, because the CDC’s Advisory Committee on Immunization Practices recommended them.

    In previous years, the committee recommended updated shots within days of the U.S. Food and Drug Administration approving them. In late August, the FDA approved the updated vaccines for people over 65 and those with one of about 30 conditions increasing their risk of severe disease, including asthma, obesity and diabetes.

    Doctors still could prescribe the vaccine “off-label” to healthy people, in the same way that they prescribe adult medications for children when an alternative specifically approved for kids isn’t available.

    This year, however, the committee won’t meet until Thursday, and may not recommend the shots when it does. Secretary of Health and Human Services Robert F. Kennedy Jr. dismissed all of the committee’s members earlier this year and replaced them with new appointees, most of whom oppose COVID-19 vaccines.

    Meg Wingerter

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  • Nearly half of people with diabetes don’t know they have it, new study finds

    (CNN) — When was the last time you had your blood sugar checked? It might be worth looking into, a new study says.

    Forty-four percent of people age 15 and older living with diabetes are undiagnosed, so they don’t know they have it, according to data analysis published Monday in the journal The Lancet Diabetes & Endocrinology.

    The study looked at data from 204 countries and territories from 2000 to 2023 in a systematic review of published literature and surveys. The findings at the global level are for people age 15 and older.

    “The majority of people with diabetes that we report on in the study have type 2 diabetes,” said Lauryn Stafford , the lead author of the study.

    Around 1 in 9 adults live with diabetes worldwide, according to the International Diabetes Foundation. In the United States, 11.6% of Americans have diabetes, according to 2021 data from the American Diabetes Association.

    “We found that 56% of people with diabetes are aware that they have the condition,” said Stafford, a researcher for the Institute for Health Metrics and Evaluation. “Globally, there’s a lot of variation geographically, and also by age. So, generally, higher-income countries were doing better at diagnosing people than low- and middle-income countries.”

    Younger people don’t know they have diabetes

    People under 35 years were much less likely to be diagnosed if they had diabetes than people in middle age or older. Just “20% of young adults with diabetes were aware of their condition,” Stafford said.

    Routine screenings aren’t promoted as much for young adults as for older adults. Many larger organizations, like the American Diabetes Association, suggest annual routine screenings for adults 35 and older.

    “You can survive with elevated glucose levels for many, many years,” Stafford said. “People end up getting diagnosed with diabetes only at the point where they have complications,” which are more common in older adults.

    Depending on how long a person has had diabetes before it’s discovered, the health impacts may vary.

    “Diagnosing diabetes early is important because it allows for timely management to prevent or delay long-term complications such as heart disease, kidney failure, nerve damage, and vision loss,” said Rita Kalyani, chief scientific and medical officer at the American Diabetes Association. She was not involved in the study.

    Around one-third of adults are diagnosed with diabetes later than their earliest symptom, according to a 2018 study.

    What symptoms should you look for?

    “Symptoms of diabetes include increased thirst or hunger, frequent urination, blurry vision, unexpected weight loss, and fatigue. However, in the early stages, most people with diabetes are asymptomatic, which highlights the importance of screening and diagnosis,” said Kalyani, a professor of medicine in the division of endocrinology, diabetes and metabolism at Johns Hopkins University.

    If you experience any of these symptoms or have a history of diabetes in your family, experts recommend you get a glucose screening.

    Globally, in 2023, about 40% of people with treated diabetes were getting optimal results and lowering their blood sugar, said Stafford. That’s why it’s important that future efforts focus on ensuring that more people receive and follow proper treatment post-diagnosis.

    That only 4 in 10 patients were seeing optimal results was surprising, as several well-established treatments, including insulin, Metformin and other drugs like GLP-1s, are available.

    People with diabetes likely also have other health issues, such as hypertension or chronic kidney disease, which can make treatment complex, Stafford added.

    Can you prevent diabetes?

    It depends.

    While there is no known way to prevent type 1 diabetes, there are many ways to prevent the more common form of type 2 diabetes.

    Reducing the amount of red and processed meats you eat can help lower your risk of type 2 diabetes, as previously reported by CNN. You could do this with a Mediterranean diet or by introducing more plant-based foods to your meals.

    In addition, limit the amount of ultraprocessed foods you eat, adding more whole foods, like fruits and nuts, instead.

    Incorporating physical activity into your regular routine can also decrease your risk of developing not only diabetes but also other chronic diseases. Fast walking for at least 15 minutes a day is just one form of exercise you can do.

    “I think, ultimately, if we can also focus more on the risk factors for developing diabetes — preventing people from needing to be diagnosed in the first place — that is also critical,” Stafford said.

    Gina Park and CNN

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  • Treat Type 1 Diabetes with a Plant-Based Diet?  | NutritionFacts.org

    Treat Type 1 Diabetes with a Plant-Based Diet?  | NutritionFacts.org

    Is it possible to reverse type 1 diabetes if caught early enough?

    The International Journal of Disease Reversal and Prevention has already had its share of miraculous disease reversals with a plant-based diet. For instance, one patient began following a whole food, plant-based diet after having two heart attacks in two months. Within months, he experienced no more chest pain, controlled his cholesterol, blood pressure, and blood sugars, and also lost 50 pounds as a nice bonus. Yet, the numbers “do not capture the patient’s transformation from feeling like a ‘dead man walking’ to being in command of his health with a new future and life.” 

    I’ve previously discussed cases of reversing the autoimmune inflammatory disease psoriasis and also talked about lupus nephritis (kidney inflammation). What about type 1 diabetes, an autoimmune disease we didn’t think we could do anything about? In contrast to type 2 diabetes, which is a lifestyle disease that can be prevented and reversed with a healthy enough diet and lifestyle, type 1 diabetes is an autoimmune disease in which our body attacks our pancreas, killing off our insulin-producing cells and condemning us to a life of insulin injections—unless, perhaps, it’s caught early enough. If a healthy enough diet is started early enough, might we be able to reverse the course of type 1 diabetes by blunting that autoimmune inflammation?

    As I discuss in my video Type 1 Diabetes Treatment: A Plant-Based Diet, we know that patients with type 1 diabetes “may be able to reduce insulin requirements and achieve better glycemic [blood sugar] control” with healthier diets. For example, children and teens were randomized to a nutritional intervention in which they increased the whole plant food density of their diet—meaning they ate more whole grains, whole fruits, vegetables, legumes (beans, split peas, chickpeas, and lentils), nuts, and seeds. Researchers found that the more whole plant foods, the better the blood sugar control.

    The fact that more whole fruits were associated “with better glycemic [blood sugar] control has important clinical implications for nutrition education” in those with type 1 diabetes. We should be “educating them on the benefits of fruit intake, and allaying erroneous concerns that fruit may adversely affect blood sugar.”

    The case series in the IJDRP, however, went beyond proposing better control of just their high blood sugars, the symptom of diabetes, but better control of the disease itself, suggesting the anti-inflammatory effects of whole healthy plant foods “may slow or prevent further destruction of the beta cells”—the insulin-producing cells of the pancreas—“if dietary intervention is initiated early enough.” Where did this concept come from?

    A young patient. Immediately following diagnosis of type 1 diabetes at age three, a patient began a vegetable-rich diet and, three years later, “has not yet required insulin therapy…and has experienced a steady decline in autoantibody levels,” which are markers of insulin cell destruction. Another child, who also started eating a healthier diet, but not until several months after diagnosis, maintains a low dose of insulin with good control. And, even if their insulin-producing cells have been utterly destroyed, individuals with type 1 diabetes can still enjoy “dramatically reduced insulin requirements,” reduced inflammation, and reduced cardiovascular risk, which is their number one cause of death over the age of 30. People with type 1 diabetes have 11 to 14 times the risk of death from cardiovascular disease compared to the general population, and it’s already the top killer among the public, so it’s closer to 11 to 14 times more important for those with type 1 diabetes to be on the only diet and lifestyle program ever proven to reverse heart disease in the majority of patients—one centered around whole plant foods. The fact it may also help control the disease itself is just sugar-free icing on the cake.

    All this exciting new research was presented in the first issue of The International Journal of Disease Reversal and Prevention. As a bonus, there’s a companion publication called the Disease Reversal and Prevention Digest. These are for the lay public and are developed with the belief I wholeheartedly share that “everyone has a right to understand the science that could impact their health.” You can go behind the scenes and hear directly from the author of the lupus series, read interviews from luminaries like Dean Ornish, see practical tips from dietitians on making the transition towards a healthier diet, and enjoy recipes. 

    The second issue includes more practical tips, such as how to eat plant-based on a budget, and gives updates on what Dr. Klaper is doing to educate medical students, what Audrey Sanchez from Balanced is doing to help change school lunches, and how Dr. Ostfeld got healthy foods served in a hospital. (What a concept!) And what magazine would be complete without an article to improve your sex life? 

    The journal is free, downloadable at IJDRP.org, and its companion digest, available at diseasereversaldigest.com, carries a subscription fee. I am a proud subscriber.

    Want to learn more about preventing type 1 diabetes in the first place? See the related posts below.

    Michael Greger M.D. FACLM

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  • Irregular Meals, Night Shifts, and Metabolic Harms  | NutritionFacts.org

    Irregular Meals, Night Shifts, and Metabolic Harms  | NutritionFacts.org

    What can shift workers do to moderate the adverse effects of circadian rhythm disruption?

    Shift workers may have higher rates of death from heart disease, stroke, diabetes, dementia, and cardiovascular disease, as well as higher rates of death from cancer. Graveyard shift, indeed! But, is it just because they’re eating out of vending machines or not getting enough sleep? Highly controlled studies have recently attempted to tease out these other factors by putting people on the same diets with the same sleep—but at the wrong time of day. Redistributing eating to the nighttime resulted in elevated cholesterol and increases in blood pressure and inflammation. No wonder shift workers are at higher risk. Shifting meals to the night in a simulated night-shift protocol effectively turned about one-third of the subjects prediabetic in just ten days. Our bodies just weren’t designed to handle food at night, as I discuss in my video The Metabolic Harms of Night Shifts and Irregular Meals.

    Just as avoiding bright light at night can prevent circadian misalignment, so can avoiding night eating. We may have no control over the lighting at our workplace, but we can try to minimize overnight food intake, which has been shown to help limit the negative metabolic consequences of shift work. When we finally do get home in the morning, though, we may disproportionately crave unhealthy foods. In one experiment, 81 percent of participants in a night-shift scenario chose high-fat foods, such as croissants, out of a breakfast buffet, compared to just 43 percent of the same subjects during a control period on a normal schedule.

    Shiftwork may also leave people too fatigued to exercise. But, even at the same physical activity levels, chronodisruption can affect energy expenditure. Researchers found that we burn 12 to 16 percent fewer calories while sleeping during the daytime compared to nighttime. Just a single improperly-timed snack can affect how much fat we burn every day. Study subjects eating a specified snack at 10:00 am burned about 6 more grams of fat from their body than on the days they ate the same snack at 11:00 pm. That’s only about a pat and a half of butter’s worth of fat, but it was the identical snack, just given at a different time. The late snack group also suffered about a 9 percent bump in their LDL cholesterol within just two weeks.

    Even just sleeping in on the weekends may mess up our metabolism. “Social jetlag is a measure of the discrepancy in sleep timing between our work days and free days.” From a circadian rhythm standpoint, if we go to bed late and sleep in on the weekends, it’s as if we flew a few time zones west on Friday evening, then flew back Monday morning. Travel-induced jet lag goes away in a few days, but what might the consequences be of constantly shifting our sleep schedule every week over our entire working career? Interventional studies have yet put it to the test, but population studies suggest that those who have at least an hour of social jet lag a week (which may describe more than two-thirds of people) have twice the odds of being overweight. 

    If sleep regularity is important, what about meal regularity? “The importance of eating regularly was highlighted early by Hippocrates (460–377 BC) and later by Florence Nightingale,” but it wasn’t put to the test until the 21st century. A few population studies had suggested that those eating meals irregularly were at a metabolic disadvantage, but the first interventional studies weren’t published until 2004. Subjects were randomized to eat their regular diets divided into six regular eating occasions a day or three to nine daily occasions in an irregular manner. Researchers found that an irregular eating pattern can cause a drop in insulin sensitivity and a rise in cholesterol levels, as well as reduce the calorie burn immediately after meals in both lean and obese individuals. The study participants ended up eating more, though, on the irregular meals, so it’s difficult to disentangle the circadian effects. The fact that overweight individuals may overeat on an irregular pattern may be telling in and of itself, but it would be nice to see such a study repeated using identical diets to see if irregularity itself has metabolic effects.

    Just such a study was published in 2016: During two periods, people were randomized to eat identical foods in a regular or irregular meal pattern. As you can see in the graph below and at 4:47 in my video, during the irregular period, people had impaired glucose tolerance, meaning higher blood sugar responses to the same food.

    They also had lower diet-induced thermogenesis, meaning the burning of fewer calories to process each meal, as seen in the graph below and at 4:55 in my video.

    The difference in thermogenesis only came out to be about ten calories per meal, though, and there was no difference in weight changes over the two-week periods. However, diet-induced thermogenesis can act as “a satiety signal.” The extra work put into processing a meal can help slake one’s appetite. And, indeed, “lower hunger and higher fullness ratings” during the regular meal period could potentially translate into better weight control over the long term. 

    The series on chronobiology is winding down with just two videos left in this series: Shedding Light on Shedding Weight and Friday Favorites: Why People Gain Weight in the Fall.

    If you missed any of the other videos, see the related posts below. 
     

    Michael Greger M.D. FACLM

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  • Faulty insulin pump tech led to hundreds of injuries, prompting app ecall

    Faulty insulin pump tech led to hundreds of injuries, prompting app ecall

    Insulin prices capped for millions, but not all qualify


    Insulin prices capped for millions, but not all qualify

    02:20

    More than 200 people with diabetes were injured after technology defect caused their insulin pump to unexpectedly shut down, according to the Food and Drug Administration.

    The software glitch has prompted the recall of more than 85,000 versions of a mobile app, called t:connect and developed by Tandem Diabetes Care, the FDA noted on Wednesday. 

    The Apple iOS-based software recall involves Version 2.7 of the mobile app, which works with the t:slim X2 insulin pump with Control-IQ technology. The issue can cause the app to continuously crash and restart, draining the pump’s battery. 

    A shutdown of the pump suspends the delivery of insulin, which can result in hyperglycemia or even ketoacidosis, a potentially life-threatening condition that can require hospitalization or intervention by a medical professional. Tandem urged patients and physicians who use the device to update the app to version 2.7.1 or later as soon as possible.

    As of April 15, there have been 224 reported injuries and no reports of death, according to the notice posted by the FDA.

    Roughly 38 million people in the U.S. have diabetes, according to the Centers for Disease Control and Prevention. Diabetes can cause health complications including blindness, kidney failure, heart disease, stroke, and loss of toes, feet or legs. 

    Kate Gibson

    Kate Gibson is a reporter for CBS MoneyWatch in New York.

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  • How Healthy Are Ancient Grains?  | NutritionFacts.org

    How Healthy Are Ancient Grains?  | NutritionFacts.org

    Ancient types of wheat, like kamut, are put to the test for inflammation, blood sugar, and cholesterol control. 

    The number one killer in the United States and around the world is what we eat. As you can see in the graph below and at 0:15 in my video Friday Favorites: Are Ancient Grains Healthier?, our diet kills millions more than tobacco. What are the five most important things we can do to improve our diets, based on the single most comprehensive global study of the health impact of nutrition? Eat less salt, eat more nuts, eat more non-starchy vegetables, eat more fruit, and, finally, eat more whole grains. 
    Any particular type of whole grains? What about so-called ancient grains? Are they any better than modern varieties? For instance, what about kamut, described as “mummy wheat” and supposedly unearthed from an Egyptian tomb?

    After WWII, the wheat industry selected particularly high-yielding varieties for pasta and bread. Over the past few years, though, some of the more ancient grains—“defined as those species that have remained unchanged over the last hundred years” despite agricultural revolutions—have been reintroduced to the market.

    As you can see below and at 1:13 in my video, nutritionally, kamut and einkorn wheat, which is the oldest wheat, have more eyesight-improving yellow carotenoid pigments, such as lutein and zeaxanthin, compared to modern bread and pastry wheat, because the pigments have been bred out of the bread intentionally. People want their white bread white, but modern pasta flour (durum wheat) maintains much of that yellow nutritional hue. 

    As you can see in the graph below and at 1:41 in my video, modern wheat may have less lutein, but it tends to have more vitamin E, as seen in the graph below and at 1:45. Based on straight vitamin and mineral concentrations, it’s pretty much a wash. Both modern and primitive kinds of wheat have a lot of each, but primitive wheats do have more antioxidant capacity, likely due to their greater polyphenol content, as you can see in the graph below and at 2:00 in my video. To know if that makes any difference, though, we have to put it to the test. 

    If you expose human liver cells to digested bread made out of ancient grains (kamut and spelt), heritage kinds of wheat, or modern strains, then expose the cells to an inflammatory stimulus, the modern wheat strains seem less able to suppress the inflammation, as you can see in the graphs below and at 2:09 in my video. The investigators conclude that even though these different grains seem to be very similar nutritionally, they appear to exert different effects on human cells, “confirming the potential health benefits of ancient grains.” 
    That was in a petri dish, though. What about people? If ancient kinds of wheat are better at suppressing inflammation, what if you took people with irritable bowel syndrome (IBS) and randomized them to receive six weeks of wheat products made out of modern wheat or ancient wheat—in this case, kamut? Same amount of wheat, just different types. If there is no difference between the wheats, there’d be no difference in people’s symptoms, right? But, when study participants in the control group were switched to the ancient wheat kamut, they experienced less abdominal pain, less frequent pain, less bloating, more satisfaction with stool consistency, and less interference with their quality of life, compared to the modern wheat. So, after switching to the ancient wheat, they had “a significant global improvement in the extent and severity of symptoms related to IBS…”

    What about liver inflammation? The liver function of those with nonalcoholic fatty liver disease randomized to eat kamut improved, compared to those eating the same amount of regular wheat, suggesting kamut is superior, as you can see below and at 3:47 in my video.

    People with diabetes, had better cholesterol and better insulin sensitivity on the same ancient grain, as shown below and at 3:57.

    And those with heart disease? They had better blood sugar control and better cholesterol, as shown below and at 4:03. 

    And, people without overt heart disease had better artery function, as you can see below and at 4:06 in my video.

    The bottom line is that findings derived from human studies suggest that ancient wheat products are more anti-inflammatory and may improve things like blood sugar control and cholesterol. “Given that the overall number of human interventional trials conducted to date are numerically insufficient, it is not possible to definitively conclude that ancient wheat varieties are superior to all commercial, modern wheat counterparts in reducing chronic disease risk.” However, the best available data do suggest they’re better for us.  

    Regardless of what type of wheat you may eat, a word to the wise: Don’t eat the plastic bread-bag clip. A 45-year-old man presented with bloody stools, and his CT scan showed the offending piece of plastic from his bag of bread, as you can see below and at 4:53 in my video. When the patient was questioned, he “admitted to habitually eating quickly without chewing properly.” 

    Whole grains—ideally intact ones and ancient and modern varieties alike—are an integral part of my Daily Dozen checklist, the healthiest of healthy things I encourage everyone to try to fit into their daily routines.  

    Whole grains are especially good for our microbiome. Learn more in the related posts below.  What about gluten? Also, see the related posts below. 

    Michael Greger M.D. FACLM

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  • What the Science Says About Time-Restricted Eating  | NutritionFacts.org

    What the Science Says About Time-Restricted Eating  | NutritionFacts.org

    Are there benefits to giving yourself a bigger daily break from eating? 
     
    The reason many blood tests are taken after an overnight fast is that meals can tip our system out of balance, bumping up certain biomarkers for disease, such as blood sugars, insulin, cholesterol, and triglycerides. Yet, as you can see in the graph below and at 0:20 in my video Time-Restricted Eating Put to the Test, fewer than one in ten Americans may even make it 12 hours without eating. As evolutionarily unnatural as getting three meals a day is, most of us are eating even more than that. One study used a smartphone app to record more than 25,000 eating events and found that people tended to eat about every three hours over an average span of about 15 hours a day. Might it be beneficial to give our bodies a bigger break? 

    Time-restricted feeding is “defined as fasting for periods of at least 12 hours but less than 24 hours,” and this involves trying to confine caloric intake to a set window of time, typically ranging from 3 to 4 hours, 7 to 9 hours, or 10 to 12 hours a day, which results in a daily fast lasting 12 to 21 hours. When mice are restricted to a daily feeding window, they gain less weight even when fed the same amount as mice “with ad-lib access.” Rodents have such high metabolisms, though, that a single day of fasting can starve away as much as 15 percent of their lean body mass. This makes it difficult to extrapolate from mouse models. You don’t know what happens in humans until you put it to the test. 
     
    The drop-out rates in time-restricted feeding trials certainly appear lower than most prolonged forms of intermittent fasting, suggesting it’s more easily tolerable, but does it work? Researchers found that when people stopped eating from 7:00 p.m. to 6:00 a.m. for two weeks, they lost about a pound each week compared to no time restriction. Note that “there were no additional instructions or recommendations on the amount or type of food consumed,” and no gadgets, calorie counting, or record-keeping either. The study participants were just told to limit their food intake to the hours of 6:00 a.m. and 7:00 p.m., a simple intervention that’s easy to understand and put into practice. 
     
    The next logical step? Put it to the test for months instead of just weeks. Obese men and women were asked to restrict eating to the eight-hour window between 10:00 a.m. and 6:00 p.m. Twelve weeks later, they had lost nearly seven pounds, as you can see in the graph below and at 2:18 in my video. This deceptively simple intervention may be operating from several different angles. People not only tend to eat more food later in the day, but eat higher fat foods later in the day. By eliminating eating in the late-evening hours, one removes prime-time snacking on the couch, a high-risk time for overeating. And, indeed, during the no-eating-after-7:00-p.m. study, the subjects were inadvertently eating about 250 fewer calories a day. Then, there are also the chronobiological benefits of avoiding late-night eating. 

    I did a whole series of videos about the role our circadian rhythms have in the obesity epidemic, how the timing of meals can be critical, and how we can match meal timing to our body clocks. Just to give you a taste: Did you know that calories eaten at dinner are significantly more fattening than the same number of calories eaten at breakfast? See the table below and at 3:08 in my video. 

    Calories consumed in the morning cause less weight gain than the same calories eaten in the evening. A diet with a bigger breakfast causes more weight loss than the same exact diet with a bigger dinner, as you can see in the graph below and at 3:21 in my video, and nighttime snacks are more fattening than the same snacks if eaten in the daytime. Thanks to our circadian rhythms, metabolic slowing, hunger, carbohydrate intolerance, triglycerides, and a propensity for weight gain are all things that go bump in the night.  


    What about the fasting component of time-restricted feeding? There’s already the double benefit of getting fewer calories and avoiding night-time eating. Does the fact that you’re fasting for 11 or 16 hours a day play any role, considering the average person may only make it about 9 hours a day without eating? How would you design an experiment to test that? What if you randomized people into two groups and had both groups eat the same number of calories a day and also eat late into the evening, but one group fasted even longer, for 20 hours? That’s exactly what researchers at the USDA and National Institute of Aging did. 
     
    Men and women were randomized to eat three meals a day or fit all of those same calories into a four-hour window between 5:00 p.m. and 9:00 p.m., then fast the rest of the day. If the weight-loss benefits from the other two time-restricted feeding studies were due to the passive calorie restriction or avoidance of late-night eating, then, presumably, both of these groups should end up the same because they’re both eating the same amount and they’re both eating late. That’s not what happened, though. As you can see below and at 4:49 in my video, after eight weeks, the time-restricted feeding group ended up with less body fat, nearly five pounds less. They got about the same number of calories, but they lost more weight. 

    As seen below and at 5:00 in my video, a similar study with an eight-hour eating window resulted in three more pounds of fat loss. So, there does seem to be something to giving your body daily breaks from eating around the clock.


    Because that four-hour eating window in the study was at night, though, the participants suffered the chronobiological consequences—significant elevations in blood pressure and cholesterol levels—despite the weight loss, as you can see below and at 5:13 in my video. The best of both worlds was demonstrated in 2018: early time-restricted feeding, eating with a narrow window earlier in the day, which I covered in my video The Benefits of Early Time-Restricted Eating. 


    Isn’t that mind-blowing about the circadian rhythm business? Calories in the morning count less and are healthier than calories in the evening. So, if you’re going to skip a meal to widen your daily fasting window, skip dinner instead of breakfast. 

    If you missed any of the other videos in this fasting series, check out the related videos below. 

    Michael Greger M.D. FACLM

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  • 2/21: CBS Evening News

    2/21: CBS Evening News

    2/21: CBS Evening News – CBS News


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    Alabama hospital pauses IVF treatment after embryo ruling; Insulin still unaffordable to some after price caps

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  • Drugmakers hiking prices for more than 700 medications, including Ozempic and Mounjaro

    Drugmakers hiking prices for more than 700 medications, including Ozempic and Mounjaro

    Fighting rising prescription drug costs


    Fighting rising prescription drug costs

    07:59

    Pharmaceutical companies are hiking prices for more than 700 medications, including popular weight-loss drugs Ozempic and Mounjaro, industry research shows.

    The average price increase at year start was about about 4.5%, the analysis from 46 Brooklyn found. That represents a slightly slower pace compared with the five prior years, when drug prices rose about 5% each year on average, the data shows. 

    Among the noteworthy increases are Ozempic and Mounjaro, two drugs that belong to a class of medications called GLP-1 agonists. While these drugs are designed to help diabetics regulate their blood sugar, they’ve also been found to be effective weight-loss drugs, prompting non-diabetics to seek out the drugs in order to slim down. As a result, these drugs have been in greater demand, leading to shortages. 

    The price of Ozempic, which is manufactured by Novo Nordisk, rose 3.5% to $984.29 for a month’s supply, while Eli Lilly’s Mounjaro rose 4.5% to about $1,000 for a month’s worth of the medication, the 46 Brooklyn data shows.

    Eli Lilly didn’t immediately return a request for comment. In a statement to CBS MoneyWatch, Novo Nordisk said that it “increases the list price of some of our medicines each year in response to changes in the health care system, market conditions and the impact of inflation.”

    Prices are increasing this year for many other widely used drugs:

    • Autoimmune disease medication Enbrel rose 5%
    • Pain medication Oxycontin rose 9%
    • Blood thinner Plavix rose 4.7%
    • Antidepressant Wellbutrin rose 9.9%

    “Technically, most brand prescription drug list price increases occur in either January or July each year, but the greatest number take place in January (and thus, January gets all the attention),” 46 Brooklyn wrote in a blog post about the drug increases. “By our counts, since 2018, more than 60% of all brand drug list price increases that occur throughout the course of each year are implemented in the month of January.”

    46 Brooklyn’s analysis may not reflect what a patient ultimately pays for a drug. Their analysis is based on the wholesale acquisition cost, which is the price that drugmakers charge to wholesalers that distribute the drugs to pharmacies. Patients may pay less due to insurance coverage as well as rebates and other discounts.

    Novo Nordisk said its list price isn’t representative of what most insured patients pay out of pocket. “That’s because after we set the list price, we negotiate with the companies that pay for our medicines (called payers) to ensure our products remain on their formularies so patients have access to our medicines,” the company said. “These payers then work directly with health insurance companies to set prices and co-pay amounts.”

    Where drug prices are dropping

    Not all medications saw price hikes, with the analysis finding that about two dozen medications dropped sharply in price at year start, including some popular insulin products. The high cost of insulin has drawn attention from the Biden administration and health policy experts, with the Human Rights Watch terming its pricing in the U.S. as a human rights violation. 

    The decline in insulin prices comes after Medicare, the insurance program for people 65 and older, capped the monthly price of insulin at $35. That prompted some drugmakers to slash the cost of insulin for a broader group of patients. The price of Novo Nordisk insulin products, sold under the Novolog brand name, declined 75% compared with a year earlier, the analysis found. 

    Other medications that saw price cuts include:

    • Erectile dysfunction drug Cialis dropped 19%
    • Antidepressant Prozac declined 18%
    • Chronic obstructive pulmonary disease medication Advair declined 22% to 60%, depending on the formulation

    While the decreases impact a small number of drugs compared with the hundreds that saw price hikes, they are nevertheless “truly remarkable from a historical perspective,” 46 Brooklyn noted. 

    “This phenomenon is particularly noteworthy due to the nature of the drugs that underwent decreases, primarily comprising historically high-utilization products such as insulins, asthma/COPD inhalers, and central nervous system (CNS) drugs,” the group noted.

    Aimee Picchi

    Aimee Picchi is the associate managing editor for CBS MoneyWatch, where she covers business and personal finance. She previously worked at Bloomberg News and has written for national news outlets including USA Today and Consumer Reports.

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  • Restricting Calories for Longevity?  | NutritionFacts.org

    Restricting Calories for Longevity?  | NutritionFacts.org

    Though a bane for dieters, a slower metabolism may actually be a good thing.

    We’ve known for more than a century that calorie restriction can increase the lifespan of animals, and metabolic slowdown may be the mechanism. That could be why the tortoise lives ten times longer than the hare. Rabbits can live for 10 to 20 years, whereas “Harriet,” a tortoise “allegedly collected from the Galapagos Islands by Charles Darwin, was estimated to be about 176 years old when she died in 2006.” Slow and steady may win the race. 
     
    As I discuss in my video The Benefits of Calorie Restriction for Longevity, one of the ways our body lowers our resting metabolic rate is by creating cleaner-burning, more efficient mitochondria, the power plants that fuel our cells. It’s like our body passes its own fuel-efficiency standards. These new mitochondria create the same energy with less oxygen and produce less free radical “exhaust.” After all, when our body is afraid famine is afoot, it tries to conserve as much energy as it can. 
     
    Indeed, the largest caloric restriction trial to date found metabolic slowing and a reduction in free radical-induced oxidative stress, both of which may slow the rate of aging. The flame that burns twice as bright burns half as long. But, whether this results in greater human longevity is an unanswered question. Caloric restriction is often said “to extend lifespan in every species studied,” but that isn’t even true of all strains within a single species. Two authors of one article, for instance, don’t even share the same view: One doesn’t think calorie restriction will improve human longevity at all, while the other suggests that a 20 percent calorie restriction starting at age 25 and sustained for 52 years could add five years onto your life. Either way, the reduced oxidative stress would be expected to improve our healthspan. 
     
    Members of the Calorie Restriction Society, self-styled CRONies (for Calorie-Restricted Optimal Nutrition), appear to be in excellent health, but they’re a rather unique, self-selected group of individuals. You don’t really know until you put it to the test. Enter the CALERIE study, the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy, the first clinical trial to test the effects of caloric restriction. 
     
    Hundreds of non-obese men and women were randomized to two years of 25 percent calorie restriction. They only ended up achieving half that, yet they still lost about 18 pounds and three inches off their waists, wiping out more than half of their visceral abdominal fat, as you can see in the graph below and at 2:47 in my video. 

    That translated into significant improvements in cholesterol levels, triglycerides, insulin sensitivity, and blood pressure, which you can see in the graph below and at 2:52 in my video. Eighty percent of those who were overweight when they started were normal-weight by the end of the trial, “compared with a 27% increase in those who became overweight in the control group.” 

    In the famous Minnesota Starvation Study that used conscientious objectors as guinea pigs during World War II, the study subjects suffered both physically and psychologically, experiencing depression, irritability, and loss of libido, among other symptoms. The participants started out lean, though, and had their calorie intake cut in half. The CALERIE study ended up being four times less restrictive, only about 12 percent below baseline calorie intake, and enrolled normal-weight individuals, which in the United States these days means overweight on average. As such, the CALERIE trial subjects experienced nothing but positive quality-of-life benefits, with significant improvements in mood, general health, sex drive, and sleep. They only ended up eating about 300 fewer calories a day than they had eaten at baseline. So, they got all of these benefits—the physiological benefits and the psychological benefits—just from cutting about a small bag of chips’ worth of calories from their daily diets. 
     
    What happened at the end of the trial, though? As researchers saw in the Minnesota Starvation Study and in calorie deprivation experiments done on Army Rangers, as soon as the subjects were released from restriction, they tended to rapidly regain the weight and sometimes even more, as you can see below and at 4:18 in my video. 

    The leaner they started out, the more their bodies seemed to drive them to overeat to pack back on the extra body fat, as seen in the graph below and at 4:27 in my video. In contrast, after the completion of the CALERIE study, even though their metabolism was slowed, the participants retained about 50 percent of the weight loss two years later. They must have acquired new eating attitudes and behaviors that allowed them to keep their weight down. After extended calorie restriction, for example, cravings for sugary, fatty, and junky foods may actually go down. 
    This is part of my series on calorie restriction, intermittent fasting, and time-restricted eating. See related videos below.

    Michael Greger M.D. FACLM

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  • Keto Diets and Diabetes  | NutritionFacts.org

    Keto Diets and Diabetes  | NutritionFacts.org

    Ketogenic diets are put to the test for diabetes reversal. 
     
    As you can see at the start of my video Does a Ketogenic Diet Help Diabetes or Make It Worse?, ketogenic diets can lower blood sugars better than conventional diets. So much so, in fact, that there is a keto product company that claims ketogenic diets can “reverse” diabetes. However, they are confusing the symptom (high blood sugars) with the disease (carbohydrate intolerance). People with diabetes can’t properly handle carbohydrates, and this manifests as high blood sugars. Clearly, if you stick to eating mostly fat, your blood sugars will stay low, but you may be actually making the underlying disease worse at the same time. 
     
    We’ve known for nearly a century that if you put people on a ketogenic diet, their carbohydrate intolerance can skyrocket within just two days. Below and at 0:46 in my video, you can see a graph from the study showing the blood sugar response two days after eating sugar. On a high-carb diet, blood sugar response is about 90 mg/dL. But, the blood sugar response to the same amount of sugar after a high-fat diet is about 190 mg/dL, nearly double. The intolerance to carbohydrates skyrocketed on a high-fat diet. 

    After one week on an 80 percent fat diet, you can quintuple your blood sugar spike in reaction to the same carb load compared to a week on a low-fat diet, as you can see in the graph below and at 1:12 in my video. 

    Even a single day of excessive dietary fat intake can do it, as you can see in the graph below and at 1:26 in my video. If you’re going in for a diabetes test, having a fatty dinner the night before can adversely affect your results. Just one meal high in saturated fat can make carbohydrate intolerance, the cause of diabetes, worse within four hours. 


    Given enough weight loss by any means, whether from cholera or bariatric surgery, type 2 diabetes can be reversed, but a keto diet for diabetes may not just be papering over the cracks, but actively throwing fuel on the fire. 
     
    I’ve been trying to think of a good metaphor. It’s easy to come up with things that just treat the symptoms without helping the underlying disease, like giving someone with pneumonia aspirin for their fever instead of antibiotics. However, a keto diet for diabetes is worse than that because it may treat the symptoms while actively worsening the disease. It may be more like curing the fever by throwing that pneumonia patient out into a snow bank or “curing” your amputated finger by amputating your hand. One of the co-founders of masteringdiabetes.org suggested it’s like a CEO who makes their bad bottom line look better by borrowing tons of cash. The outward numbers look better, but on the inside, the company is just digging itself into a bigger hole. 
     
    Do you remember The Club, that popular car anti-theft device that attaches to the steering wheel and locks it in place so the steering column can only turn a few inches? Imagine you’re in a car at the top of a hill with the steering wheel locked. Then, the car starts rolling down the hill. What do you do? Imagine there’s also something stuck under your brake pedal. The keto-diet equivalent response to this situation is who cares if you’re barreling down into traffic with a locked steering wheel and no brakes—just stick to really straight deserted roads without any stop signs or traffic lights. If you do that, problem solved! The longer you go, the more speed you’ll pick up. If you should hit a dietary bump in the road or start to veer off the path, the consequences could get more and more disastrous over time. However, if you stick to the keto straight and narrow, you’ll be a-okay! In contrast, the non-keto response would be to just unlock the steering wheel and dislodge whatever’s under your brake. In other words, fix the underlying problem instead of just whistling past—and then into—the graveyard. 
     
    The reason keto proponents claim they can “reverse” diabetes is they can successfully wean type 2 diabetics off their insulin. That’s like faith-healing someone out of the need for a wheelchair by making them stay in bed the rest of their life. No need for a wheelchair if you never move. Their carbohydrate intolerance isn’t gone. Their diabetes isn’t gone. In fact, it could be just as bad or even worse. Type 2 diabetes is reversed when you are weaned off insulin while eating a normal diet like everyone else. Then and only then do you not have diabetes anymore. A true diabetes reversal diet, as you can see below and at 4:58 in my video, is practically the opposite of a ketogenic diet: getting diabetics off their insulin within a matter of weeks by eating more than 300 grams of carbs a day! 
    The irony doesn’t stop there. One of the reasons people with diabetes suffer such nerve and artery damage is due to an inflammatory metabolic toxin known as methylglyoxal, which forms at high blood sugar levels. Methylglyoxal is the most potent creator of advanced glycation end products (AGEs), which are implicated in degenerative diseases—from Alzheimer’s and cataracts to kidney disease and strokes, as you can see below and at 5:31 in my video. 

    You get AGEs in your body from two sources: You can eat them preformed in your diet or make them internally from methylglyoxal if you have high blood sugar levels. On a keto diet, one would expect high exposure to preformed AGEs, since they’re found concentrated in animal-derived foods high in fat and protein, but we would expect less internal, new formation due to presumably low levels of methylglyoxal, given lower blood sugars from not eating carbs. Dartmouth researchers were surprised to find more methylglyoxal! As shown in the graph below and at 6:11 in my video, a few weeks on the Atkins diet led to a significant increase in methylglyoxal levels. Those in active ketosis did even worse, doubling the level of this glycotoxin in their bloodstream. 

    It turns out that high sugars may not be the only way to create this toxin, as you can see below and at 6:24 in my video. One of the ketones you make on a ketogenic diet is acetone (known for its starring role in nail polish remover). Acetone does more than just make keto dieters fail breathalyzer tests, “feel queasy and light-headed, and develop what’s been described as ‘rotten apple breath.’” Acetone can oxidize in the blood to form acetol, which may be a precursor for methylglyoxal.

    That may be why keto dieters can end up with levels of this glycotoxin as high as those with out-of-control diabetes, which can cause the nerve damage and blood vessel damage you see in diabetics. That’s another way keto dieters can end up with a heart attack. The irony of treating diabetes with a ketogenic diet may extend beyond just making the underlying diabetes worse, but by mimicking some of the disease’s dire consequences. 

    This is part of a seven-video series on keto, which you can find in related videos below.

    I also recently tackled diabetes.

    Michael Greger M.D. FACLM

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  • Muscle Shrinkage and Bone Loss on Keto Diets?  | NutritionFacts.org

    Muscle Shrinkage and Bone Loss on Keto Diets?  | NutritionFacts.org

    Ketogenic diets have been found to undermine exercise efforts and lead to muscle shrinkage and bone loss. 
     
    An official International Society of Sports Nutrition position paper covering keto diets notes the “ergolytic effect” of keto diets on both high- and low-intensity workouts. Ergolytic is the opposite of ergogenic. Ergogenic means performance-boosting, whereas ergolytic means performance-impairing. 
     
    For nonathletes, ketosis may also undermine exercise efforts. Ketosis was correlated with increased feelings of “perceived exercise effort” and “also significantly correlated to feelings of ‘fatigue’ and to ‘total mood disturbance,’” during physical activity. “Together, these data suggest that the ability and desire to maintain sustained exercise might be adversely impacted in individuals adhering to ketogenic diets for weight loss.” 
     
    You may recall that I’ve previously discussed that shrinkage of measured muscle mass among CrossFit trainees has been reported. So, a ketogenic diet may not just blunt the performance of endurance athletes, but their strength training as well. As I discuss in my video Keto Diets: Muscle Growth and Bone Density, study participants performed eight weeks of the battery of standard upper and lower body training protocols, like bench presses, pull-ups, squats, and deadlifts, and there was no surprise. You boost muscle mass—unless you’re on a keto diet, in which case there was no significant change in muscle mass after all that effort. Those randomized to a non-ketogenic diet added about three pounds of muscle mass, whereas the same amount of weight lifting on the keto diet tended to subtract muscle mass by about 3.5 ounces on average. How else could you do eight weeks of weight training and not gain a single ounce of muscle on a ketogenic diet? Even keto diet advocates call bodybuilding on a ketogenic diet an “oxymoron.” 
     
    What about bone loss? Sadly, bone fractures are one of the side effects that disproportionately plague children placed on ketogenic diets, along with slowed growth and kidney stones. Ketogenic diets may cause a steady rate of bone loss as measured in the spine, presumed to be because ketones are acidic, so keto diets can put people in what’s called a “chronic acidotic state.” 
     
    Some of the case reports of children on keto diets are truly heart-wrenching. One nine-year-old girl seemed to get it all, including osteoporosis, bone fractures, and kidney stones, then she got pancreatitis and died. Pancreatitis can be triggered by having too much fat in your blood. As you can see in the graph below and at 2:48 in my video, a single high-fat meal can cause a quintupling of the spike in triglycerides in your bloodstream within hours of consumption, which can put you at risk for inflammation of the pancreas.  

    The young girl had a rare genetic disorder called glucose transporter deficiency syndrome. She was born with a defect in ferrying blood sugar into her brain. That can result in daily seizures starting in infancy, but a ketogenic diet can be used as a way to sneak fuel into the brain, which makes a keto diet a godsend for the 1 in 90,000 families stricken with this disorder.

    As with anything in medicine, it’s all about risks versus benefits. As many as 30 percent of patients with epilepsy don’t respond to anti-seizure drugs. Unfortunately, the alternatives aren’t pretty and can include brain surgery that implants deep electrodes through the skull or even removes a lobe of your brain. This can obviously lead to serious side effects, but so can having seizures every day. If a ketogenic diet can help with seizures, the pros can far outweigh the cons. For those just choosing a diet to lose weight, though, the cost-benefit analysis would really seem to go the other way. Thankfully, you don’t need to mortgage your long-term health for short-term weight loss. We can get the best of both worlds by choosing a healthy diet, as I discussed in my video Flashback Friday: The Weight Loss Program That Got Better with Time.
     
    Remember the study that showed the weight loss was nearly identical in those who had been told to eat the low-carb Atkins diet for a year and those told to eat the low-fat Ornish diet, as seen below and at 4:18 in my video? The authors concluded, “This supports the practice of recommending any diet that a patient will adhere to in order to lose weight.” That seems like terrible advice. 

    There are regimens out there like “The Last Chance Diet which consisted of a low-calorie liquid formula made from leftover byproducts from a slaughterhouse [that] was linked to approximately 60 deaths from cardiovascular-related events.” An ensuing failed lawsuit from one widower laid the precedent for the First Amendment protection for those who produce deadly diet books. 

    It’s possible to construct a healthy low-carb diet or an unhealthy low-fat one—a diet of cotton candy would be zero fat—but the health effects of a typical low-carb ketogenic diet like Atkins are vastly different from a low-fat plant-based diet like Ornish’s. As you can see in the graph below and at 5:26 in my video, they would have diametrically opposed effects on cardiovascular risk factors in theory, based on the fiber, saturated fat, and cholesterol contents of their representative meal plans. 

    And when actually put to the test, low-carb diets were found to impair artery function. Over time, blood flow to the heart muscle itself is improved on an Ornish-style diet and diminished on a low-carb one, as shown below and at 5:44 in my video. Heart disease tends to progress on typical weight-loss diets and actively worsens on low-carb diets, but it may be reversed by an Ornish-style diet. Given that heart disease is the number one killer of men and women, “recommending any diet that a patient will adhere to in order to lose weight” seems irresponsible. Why not tell people to smoke? Cigarettes can cause weight loss, too, as can tuberculosis and a meth habit. The goal of weight loss is not to lighten the load for your pallbearers. 

     
    For more on keto diets, see my videos on the topic. Interested in enhancing athletic performance? Check out the related videos below. 

    Michael Greger M.D. FACLM

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  • The Safety of Keto Diets  | NutritionFacts.org

    The Safety of Keto Diets  | NutritionFacts.org

    What are the effects of ketogenic diets on nutrient sufficiency, gut flora, and heart disease risk? 

    Given the decades of experience using ketogenic diets to treat certain cases of pediatric epilepsy, a body of safety data has accumulated. Nutrient deficiencies would seem to be the obvious issue. Inadequate intake of 17 micronutrients, vitamins, and minerals has been documented in those on strict ketogenic diets, as you can see in the graph below and at 0:14 in my video Are Keto Diets Safe?. 

    Dieting is a particularly important time to make sure you’re meeting all of your essential nutrient requirements, since you may be taking in less food. Ketogenic diets tend to be so nutritionally vacuous that one assessment estimated that you’d have to eat more than 37,000 calories a day to get a sufficient daily intake of all essential vitamins and minerals, as you can see in the graph below and at 0:39 in my video. 


    That is one of the advantages of more plant-based approaches. As the editor-in-chief of the Journal of the American Dietetic Association put it, “What could be more nutrient-dense than a vegetarian diet?” Choosing a healthy diet may be easier than eating more than 37,000 daily calories, which is like putting 50 sticks of butter in your morning coffee. 
     
    We aren’t just talking about not reaching your daily allowances either. Children have gotten scurvy on ketogenic diets, and some have even died from selenium deficiency, which can cause sudden cardiac death. The vitamin and mineral deficiencies can be solved with supplements, but what about the paucity of prebiotics, the dozens of types of fiber, and resistant starches found concentrated in whole grains and beans that you’d miss out on? 
     
    Not surprisingly, constipation is very common on keto diets. As I’ve reviewed before, starving our microbial self of prebiotics can have a whole array of negative consequences. Ketogenic diets have been shown to “reduce the species richness and diversity of intestinal microbiota,” our gut flora. Microbiome changes can be detected within 24 hours of switching to a high-fat, low-fiber diet. A lack of fiber starves our good gut bacteria. We used to think that dietary fat itself was nearly all absorbed in the small intestine, but based on studies using radioactive tracers, we now know that about 7 percent of the saturated fat in a fat-rich meal can make it down to the colon. This may result in “detrimental changes” in our gut microbiome, as well as weight gain, increased leaky gut, and pro-inflammatory changes. For example, there may be a drop in beneficial Bifidobacteria and a decrease in overall short-chain fatty acid production, both of which would be expected to increase the risk of gastrointestinal disorders. 
     
    Striking at the heart of the matter, what might all of that saturated fat be doing to our heart? If you look at low-carbohydrate diets and all-cause mortality, those who eat lower-carb diets suffer “a significantly higher risk of all-cause mortality,” meaning they live, on average, significantly shorter lives. However, from a heart-disease perspective, it matters if it’s animal fat or plant fat. Based on the famous Harvard cohorts, eating more of an animal-based, low-carb diet was associated with higher death rates from cardiovascular disease and a 50 percent higher risk of dying from a heart attack or stroke, but no such association was found for lower-carb diets based on plant sources.  
     
    And it wasn’t just Harvard. Other researchers have also found that “low-carbohydrate dietary patterns favoring animal-derived protein and fat sources, from sources such as lamb, beef, pork, and chicken, were associated with higher mortality, whereas those that favored plant-derived protein and fat intake, from sources such as vegetables, nuts, peanut butter, and whole-grain bread, were associated with lower mortality…” 
     
    Cholesterol production in the body is directly correlated to body weight, as you can see in the graph below and at 3:50 in my video. 

    Every pound of weight loss by nearly any means is associated with about a one-point drop in cholesterol levels in the blood. But if we put people on very-low-carb ketogenic diets, the beneficial effect on LDL bad cholesterol is blunted or even completely neutralized. Counterbalancing changes in LDL or HDL (what we used to think of as good cholesterol) are not considered sufficient to offset this risk. You don’t have to wait until cholesterol builds up in your arteries to have adverse effects either; within three hours of eating a meal high in saturated fat, you can see a significant impairment of artery function. Even with a dozen pounds of weight loss, artery function worsens on a ketogenic diet instead of getting better, which appears to be the case with low-carb diets in general.  

    For more on keto diets, check out my video series here. 

    And, to learn more about your microbiome, see the related videos below.

    Michael Greger M.D. FACLM

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  • Can You Sustain Weight Loss on Ketosis?  | NutritionFacts.org

    Can You Sustain Weight Loss on Ketosis?  | NutritionFacts.org

    Might the appetite-suppressing effects of ketosis improve dietary compliance? 

    The new data are said to debunk “some, if not all, of the popular claims made for extreme carbohydrate restriction,” but what about ketones suppressing hunger? In a tightly controlled metabolic ward study where the ketogenic diet made things worse, everyone ate the same number of calories, but those on a keto diet lost less body fat. But, out in the real world, all of those ketones might spoil your appetite enough that you’d end up eating significantly less overall. On a low-carb diet, people end up storing 300 more calories of fat every day. Outside of the laboratory, though, if you were in a state of ketosis, might you be able to offset that if you were able to sustainably eat significantly less? 
     
    Paradoxically, as I discuss in my video Is Weight Loss on Ketosis Sustainable?, people may experience less hunger on a total fast compared to an extremely low-calorie diet. This may be thanks to ketones. In this state of ketosis, when you have high levels of ketones in your bloodstream, your hunger is dampened. How do we know it’s the ketones? If you inject ketones straight into people’s veins, even those who are not fasting lose their appetite, sometimes even to the point of getting nauseated and vomiting. So, ketones can explain why you might feel hungrier after a few days on a low-calorie diet than on a total zero-calorie diet—that is, a fast. 
     
    Can we then exploit the appetite-suppressing effects of ketosis by eating a ketogenic diet? If you ate so few carbs to sustain brain function, couldn’t you trick your body into thinking you’re fasting and get your liver to start pumping out ketones? Yes, but is it safe? Is it effective? 
     
    As you can see below and at 1:58 in my video, a meta-analysis of 48 randomized trials of various branded diets found that those advised to eat low-carb diets and those told to eat low-fat ones lost nearly identical amounts of weight after a year.

    Obviously, high attrition rates and poor dietary adherence complicate comparisons of efficacy. The study participants weren’t actually put on those diets; they were just told to eat in those ways. Nevertheless, you can see how even just moving in each respective direction can get rid of a lot of CRAP (which is Jeff Novick’s acronym for Calorie-Rich And Processed foods). After all, as you can see in the graph below and at 2:37 in my video, the four largest calorie contributors in the American diet are refined grains, added fats, meat, and added sugars. 

    Low-carb diets cut down on refined grains and added sugars, and low-fat diets tend to cut down on added fats and meat, so they both tell people to cut down on donuts. Any diet that does that already has a leg up. I figure a don’t-eat-anything-that-starts-with-the-letter-D diet could also successfully cause weight loss if it caused people to cut down on donuts, danishes, and Doritos, even if it makes no nutritional sense to exclude something like dill. 

    The secret to long-term weight-loss success on any diet is compliance. Diet adherence is difficult, though, because any time you try to cut calories, your body ramps up your appetite to try to compensate. This is why traditional weight-loss approaches, like portion control, tend to fail. For long-term success, measured not in weeks or months but in years and decades, this day-to-day hunger problem must be overcome. On a wholesome plant-based diet, this can be accomplished thanks in part to calorie density because you’re just eating so much food. On a ketogenic diet, it may be accomplished with ketosis. In a systematic review and meta-analysis entitled “Do Ketogenic Diets Really Suppress Appetite,” researchers found that the answer was yes. Ketogenic diets also offer the unique advantage of being able to track dietary compliance in real-time with ketone test strips you can pee on to see if you’re still in ketosis. There’s no pee stick that will tell you if you’re eating enough fruits and veggies. All you have is the bathroom scale. 

    Keto compliance may be more in theory than practice, though. Even in studies where ketogenic diets are being used to control seizures, dietary compliance may drop below 50 percent after a few months. This can be tragic for those with intractable epilepsy, but for everyone else, the difficulty in sticking long-term to ketogenic diets may actually be a lifesaver. I’ll talk about keto diet safety next. 

    The keto diet is in contrast to a diet that would actually be healthful to stick to. See, for example, my video series on the CHIP program here. 
     
    This was the fourth video in a seven-part series on keto diets. If you haven’t yet, be sure to watch the others listed in the related videos below. 

    Michael Greger M.D. FACLM

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  • Can You Lose Weight on a Keto Diet?  | NutritionFacts.org

    Can You Lose Weight on a Keto Diet?  | NutritionFacts.org

    Let’s dive into ketogenic diets and their $33-billion gimmick. 

    The carbohydrate–insulin model of obesity, the underlying theory that ketogenic diets have some sort of metabolic advantage, has been experimentally falsified. Keto diet proponents’ own studies showed the exact opposite: Ketogenic diets actually put you at a metabolic disadvantage and slow the loss of body fat. How much does fat loss slow down on a low-carb diet?  

    As I discuss in my video Keto Diet Results for Weight Loss, if you cut about 800 calories of carbohydrates from your diet a day, you lose 53 grams of body fat a day. But if you cut the same number of fat calories, you lose 89 grams of fat a day. Same number of calories cut, but nine butter pats’ worth of extra fat melting off your body each day on a low-fat diet, compared to a low-carb one. Same number of calories, but about 80 percent more fat loss when you cut down on fat instead of carbs. You can see a graph of these results below and at 1:07 in my video. The title of the study speaks for itself: “Calorie for Calorie, Dietary Fat Restriction Results in More Body Fat Loss Than Carbohydrate Restriction in People with Obesity.” 

    Just looking at the bathroom scale, though, would mislead you into thinking the opposite. After six days on the low-carb diet, study subjects lost four pounds. On the low-fat diet, they lost less than three pounds, as you can see in the graph below and at 1:40 in my video. So, according to the scale, it looked like the low-carb diet wins hands down. You can see why low-carb diets are so popular. What was happening inside their bodies, however, tells the real story. The low-carb group was losing mostly lean mass—water and protein. This loss of water weight helps explain why low-carb diets have “been such a persistent theme for authors of diet books and such ‘cash cows’ for publishers,” going back more than the last 150 years. That’s their secret. As one weight-loss expert noted, “Rapid water loss is the $33-billion diet gimmick.” 

    When you eat carbohydrates, your body bulks up your muscles with glycogen for quick energy. Eat a high-carbohydrate diet for three days, and you may add about three pounds of muscle mass onto your arms and legs, as you can see below and at 2:34 in my video. Those glycogen stores drain away on a low-carb diet and pull water out with it. (The ketones also need to be flushed out of the kidneys, pulling out even more water.) On the scale, that can manifest as four more pounds coming off within ten days, but that “was all accounted for by losses in total body water”—that is water loss. 

    The bottom line: Keto diets just don’t hold water. 

    The thrill of seeing the pounds come off so quickly on the scale keeps many coming back to the low-carb altar. When the diet fails, the dieters often blame themselves, but the intoxication of that initial, rapid weight loss may tempt them back, like getting drunk again after forgetting how terrible the last hangover was. This has been dubbed the “false hope syndrome.” “The diet industry thrives for two reasons—big promises and repeat customers,” something low-carb diets were built for, given that initial, rapid water loss. 

    What we care about is body fat. In six days, the low-fat diet extracted a total of 80 percent more fat from the body than the low-carb diet. It’s not just one study either. As you can see below and at 3:54 in my video, you can look at all of the controlled feeding trials where researchers compared low-carb diets to low-fat ones, swapping the same number of carb calories for fat calories or vice versa. If a calorie is just a calorie, then all of the studies should have crossed that zero line in the middle, straddling “favors low-fat diet” and “favors low-carb diet,” and indeed six did. One study showed more fat loss on a low-carb diet, but every other study favored the low-fat diet—more loss of body fat eating the same number of calories. When you put all of the studies together, we’re talking 16 more grams of daily body fat lost on the low-fat diets. That’s like four more pats of butter melting off your body on a daily basis. Less fat in the mouth means less fat on the hips, even when you’re taking in the same number of calories. 

    This is the third installment of my seven-part series on keto diets. 

    This keto research came from the deep dive I took for my book How Not to Diet. (All proceeds I receive from my books are donated to charity.) You can learn more about How Not to Diet and order it here. Also please feel free to check out some of my popular weight-loss videos in related videos below. 

    Michael Greger M.D. FACLM

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  • Testing the Keto Diet Theory  | NutritionFacts.org

    Testing the Keto Diet Theory  | NutritionFacts.org

    Do low-carb and ketogenic diets have a metabolic advantage for weight loss? 

    When you don’t eat enough carbohydrates, you force your body to burn more fat. “However, this rise in fat oxidation [burning] is often misconstrued as a greater rate of net FM [fat-mass] reduction” in the body, ignoring the fact that, on a ketogenic diet, your fat intake shoots up, too. What happens to your overall body fat balance? You can’t empty a tub by widening the drain if you’re opening the faucet at the same time. Low-carb advocates had a theory, though, the “carbohydrate–insulin model of obesity,” which I discuss in my video Keto Diet Theory Put to the Test.  

    Proponents of low-carb diets, whether a ketogenic diet or a more relaxed form of carbohydrate restriction, suggested that decreased insulin secretion would lead to less fat storage, so even if you were eating more fat, less of it would stick to your frame. We’d burn more and store less, the perfect combination for fat loss—or so the theory went. To their credit, instead of just speculating about it, they decided to put it to the test. 

    Gary Taubes formed the Nutrition Science Initiative (NuSI) to sponsor research to validate the carbohydrate–insulin model. He’s the journalist who wrote the controversial 2002 New York Times Magazine article “What If It’s All Been a Big Fat Lie?” which attempted to turn nutrition dogma on its head by arguing in favor of the Atkins diet with its bunless bacon cheeseburgers based on the carbohydrate–insulin model. (Much of Nina Teicholz’s book The Big Fat Surprise is simply recycled from Taubes’ earlier work.)  

    In response, some of the very researchers Taubes cited to support his thesis accused him of twisting their words. One said, “The article was incredibly misleading…I was horrified.” Said another, “He took this weird little idea and blew it up, and people believed him…What a disaster.” It doesn’t matter what people say, though. All that matters is the science. 

    Taubes attracted $40 million in committed funding for his Nutrition Science Initiative to prove to the world that you could lose more body fat on a ketogenic diet. NuSI contracted noted researcher Kevin Hall from the National Institutes of Health to perform the study. Seventeen overweight or obese men were effectively locked in what’s called a metabolic ward for two months to allow researchers total control over their diets. For the first month, they were placed on a typical high-carbohydrate diet (50 percent carbs, 35 percent fat, 15 percent protein), then were switched to a low-carb ketogenic diet (only 5 percent of calories from carbohydrates and 80 percent fat) for the second month. Both diets had the same number of daily calories. So, if a calorie is a calorie when it comes to weight loss, there should be no difference in body fat loss on the regular diet versus the ketogenic diet. If Taubes was right, though, if fat calories were somehow less fattening, then body fat loss would become accelerated on a keto diet. Instead, in the very study funded by the Nutrition Science Initiative, researchers found that body fat loss slowed during the ketogenic diet. 

    Why do people think the keto diet works if it actually slows fat loss? Well, as you can see in the graph below and at 3:40 in my video, if you looked only at the readings on bathroom scales, the ketogenic diet would seem like a smashing success. Participants went from losing less than a pound a week on the regular diet during the first two weeks of the study to losing three and a half pounds within seven days after switching to the ketogenic diet. What was happening inside their bodies, however, told a totally different story: Their rate of body fat loss was slowed by more than half. So, most of what they were losing was just water weight. It’s presumed the reason they started burning less fat on a ketogenic diet was because, without the preferred fuel of carbohydrates, their bodies started burning more of their own protein—and that’s exactly what happened. Switching to a ketogenic diet made them lose less fat mass and more fat-free mass. Indeed, they lost more lean mass. That may help explain why the leg muscles of CrossFit trainees placed on a ketogenic diet may shrink as much as 8 percent. The vast lateralis, the biggest quad muscle in your leg, shrunk in thickness by 8 percent on a ketogenic diet. 

    Yes, the study subjects started burning more fat on the ketogenic diet, but they were also eating so much more fat on the keto diet that they ended up retaining more fat in their body, despite the lower insulin levels. This is “diametrically opposite” to what the keto crowd predicted, and this is from the guy Nutrition Science Initiative paid to support its theory. In science-speak, “the carbohydrate–insulin model failed experimental interrogation.” 

    In light of this “experimental falsification” of the low-carb theory, the Nutrition Science Initiative effectively collapsed but, based on its tax returns, not before Taubes and his co-founder personally pocketed millions of dollars in compensation. 

    This is the second installment in my seven-part series on keto diets. In case you missed them, check out the other related videos below.  

    The more things change, the more they stay the same. I created a whole website about the Atkins Diet, but, sadly, people keep falling into the low-carb trap. You can find some of my older videos on low-carb diets listed below. 

    Michael Greger M.D. FACLM

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  • Bernie Sanders Demands Probe of Proposal To Patent Taxpayer-Funded Cancer Drug | High Times

    Bernie Sanders Demands Probe of Proposal To Patent Taxpayer-Funded Cancer Drug | High Times

    Sen. Bernie Sanders is once again keeping drug makers in check, suggesting that people living with cancer are being preyed on by greedy interests.

    On Monday, Sanders demanded a Department of Health-led investigation into a proposal to grant a company with an exclusive patent license for cancer treatment and methods, produced with public resources and a potential conflict of interest.

    The sexually transmitted infection Human papillomavirus (HPV) can lead to six types of cancer and most cervical cancer, the National Cancer Institute (NCI) reports. It can be dormant for years or cause genital warts or worse. Last month, National Institutes of Health (NIH) proposed granting Kingston, New Jersey-based Scarlet TCR a patent for a T-cell therapy for HPV, which has undergone a Phase I trial and has a Phase II trial scheduled to conclude in 2025.

    There’s no cure for HPV, but drug developers are examining T-cell therapies to combat HPV and the cancers it leads to, including Scarlet TCR. Sometimes they’re gene-engineered. (CBD is also being explored for its potential to inhibit cervical cancer cells.) 

    There’s a problem though. The patent proposal and the company’s ties to an ex-government employee and other inconsistencies were revealed in an Oct. 18 report by The American Prospect. The NIH quietly applied to be granted “an exclusive patent for a cancer drug, potentially worth hundreds of millions or even billions of dollars, to an obscure company staffed by one of its former employees,” The American Prospect reports.

    Sanders, chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, demanded a probe of the patent proposal in an Oct. 23 letter to Christi Grimm, who is inspector general of the U.S. Department of Health and Human Services. The HELP committee also announced Sander’s open letter on Oct. 23.

    Sanders suggested the NIH is allowing a company to take advantage of a life-saving cancer drug.

    “I am growing increasingly alarmed that not only has the NIH abdicated its authority to ensure that the new drugs it helps develop are reasonably priced, it may actually be exceeding its authority to grant monopoly licenses to pharmaceutical companies that charge the American people, by far, the highest prices in the world for prescription drugs,” Sanders wrote. “One particularly egregious example has recently been brought to my attention that I believe demands your immediate attention.”

    Sanders argued that the NIH should be doing more to lower the cost of drug therapy.

    “There does not appear to be anything reasonable and necessary about granting a monopoly for a treatment that was invented, manufactured and tested by the NIH, is already in late stage trials and could potentially enrich a former NIH employee who was one of the major government researchers of this treatment,” Sanders wrote. “Based on current law and the best interest of U.S. taxpayers who paid for this cancer therapy, it would seem to make more sense for the NIH to offer non-exclusive licenses so that multiple manufacturers can produce this important cancer therapy at reasonable and affordable prices. The apparent abuse of the system by the NIH with respect to the exclusive patent license for this cancer therapy is so egregious that it has been characterized as a ‘how-to-become-a-billionaire program run by the NIH.’”

    “If accurate,” Sanders wrote, “that would be absolutely unacceptable. The NIH should be doing everything within its authority to lower the outrageously high price of prescription drugs. It should not be granting a monopoly on a promising taxpayer-funded therapy that could cost hundreds of thousands of dollars for cancer patients in a way that appears to exceed its statutory authority.”

    The American Prospect story pointed out that the NIH offering an exclusive license for a cancer treatment to a company with no website or SEC filings staffed by a former NIH employee

    More Ethical Drug Research

    There is historical precedence on life-saving drugs or therapies that didn’t need a patent: On Jan. 23, 1923, Sir Frederick G. Banting, James B. Collip, and Charles Best, discoverers of insulin, were awarded U.S. patents on insulin and the methods used. They all sold these patents to the University of Toronto for $1 each. Banting said, “Insulin does not belong to me, it belongs to the world.” 

    While things have changed and the price of insulin skyrocketed, new efforts are being made by the drug’s top three makers to make insulin affordable once again.

    When the polio vaccine was found to be 90% effective, its discoverer wasn’t in it for the money. On April 12, 1955, Edward R. Murrow asked Jonas Salk who owned the patent to the polio vaccine. “Well, the people, I would say,” Salk responded. “There is no patent. Could you patent the sun?”

    In today’s pharmaceutical world, some of those values are lost.

    Benjamin M. Adams

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