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

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

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    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. 

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    Michael Greger M.D. FACLM

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  • Testing the Keto Diet Theory  | NutritionFacts.org

    Testing the Keto Diet Theory  | NutritionFacts.org

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    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. 

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    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

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    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.

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    Benjamin M. Adams

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  • Water Shortage Forcing More Golf Courses To Use Insulin

    Water Shortage Forcing More Golf Courses To Use Insulin

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    SACRAMENTO, CA—In an effort to abide by emergency conservation measures issued by the State Water Resources Control Board, golf courses in California have been forced to use insulin to maintain their fairways and greens, sources confirmed Friday. “Unfortunately, the state’s restrictions on water usage have left us with no choice but to buy up all the available insulin and dump it on the grass,” said Pebble Beach CEO David Stivers, who added that despite the high price tag, insulin was transparent and mostly liquid, making it a workable backup option for hydrating the four renowned golf courses his company operates on the Monterey Peninsula. “We know there are some secondary medical uses for the substance and that it’s in high demand. But it’s imperative that something goes into our sprinkler system and water features, so it will have to do. As other courses have found themselves in the same situation, we’ve had to purchase every ounce of the stuff on the world market to insure our golfers can tee off, without interruption, for years to come. We’re all making sacrifices here to help relieve the water shortage, so diabetics will simply have to learn to go without.” At press time, Stivers announced that his golf courses would also be replenishing their sand traps with 60,000 tons of powdered baby formula.

    This Week’s Most Viral News: August 4, 2023

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  • California announces plan to produce $30 insulin

    California announces plan to produce $30 insulin

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    California Gov. Gavin Newsom announced Saturday that the state has launched a 10-year partnership with a drug maker to produce insulin for its residents at a significantly lower cost.

    The state plans to sell insulin at a cost of $30 for a 10-milliliter vial, Newsom said in a press conference Saturday near Los Angeles. The insulin will be manufactured by Civica Rx, a nonprofit drug company. The product is not expected on store shelves until at least next year. 

    “Thank you for being willing to disrupt the market,” Newsom said. “Thank you for being willing to save lives without fear of failure, but more importantly without money being your motivator.” 

    Gavin Newsom
    Dr. Tanya Spirtos, M.D., president-elect of the California Medical Association, left, speaks briefly with California Governor Gavin Newsom, right, following a press conference in Downey, California. Newsom announced that the state has launched a partnership with a company to produce affordable insulin. March 18, 2023. 

    Francine Orr / Los Angeles Times via Getty Images


    Back in July 2022, Newsom announced that he had approved a budget that allocated $100 million for California to make its own insulin.

    Many questions remain, however. The state and Civica have yet to locate a California-based manufacturing facility. Regulatory approvals will be needed. It’s possible competitors could slash their prices and undercut the state product.

    This also comes after several major insulin manufacturers recently announced that they will be slashing prices too. Eli Lilly and Novo Nordisk said this month they will lower the cost of insulin by up to 70% and 75%, respectively.

    Eli Lilly said it would automatically cap out-of-pocket insulin costs at $35 for insured individuals, and expand its Insulin Value Program.

    Anthony Wright, executive director of Health Access California, a statewide consumer health care advocacy group, welcomed Newsom’s announcement, saying efforts by California and others to develop a competing generic are likely a factor in getting insulin manufacturers to cut their prices.

    Still, there are obstacles.

    “The work to develop a generic, get FDA approval and set up manufacturing will take real time,” Wright said in an email. “There may even be more time in the effort to get doctors to prescribe the drug, insurers and (pharmacy benefit managers) to include it on their formularies and patients and the public to accept and ask for it.”

    There could be other risks. State analysts have warned that California’s entry into the market could prompt other manufacturers to reduce the availability of their drugs, a potential unintended consequence.

    Even with the challenges of entering a competitive, established market, Newsom said taxpayers would have “very ample protections.”

    If for whatever reason the deal didn’t work out to the state’s benefit, “there’s all kinds of provisions that would allow us to … pull out,” he said.

    According to state documents, the proposed program could save many patients between $2,000 and $4,000 a year. In addition, lower costs could result in substantial savings because the state buys the product every year for the millions of people on its publicly funded health plans.

    Just days ago, President Biden said his administration is focused “intensely” on lowering health care costs, including pressuring pharmaceutical companies to lower the costs of insulin. Legislation enacted last year capped copayments for insulin at $35 per month for Medicare beneficiaries. Biden has proposed extending that cap to all Americans.

    The state of California also is exploring the possibility of bringing other drugs to market, including the overdose medication Naloxone. The drug, available as a nasal spray and in an injectable form, is considered a key tool in the battle against a nationwide overdose crisis.

    “We are not stopping here,” Newsom said.

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  • Eli Lilly Slashed Insulin Prices. This Starts a Race to the Bottom.

    Eli Lilly Slashed Insulin Prices. This Starts a Race to the Bottom.

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    Bram Sable-Smith and Samantha Young

    When drugmaker Eli Lilly announced Wednesday it will slash the list price for some of its insulin products following years of criticism from lawmakers and activists that the price of the lifesaving hormone had become unaffordable, the news raised questions about what will happen to other efforts to provide low-cost insulin.

    Civica, a nonprofit drugmaker based in Utah, for example, has said it plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Eli Lilly’s generic insulin.

    In December, billionaire entrepreneur Mark Cuban said his new company, the Mark Cuban Cost Plus Drug Co., planned to sell low-cost insulin. And California is poised to launch an ambitious program to manufacture its own brand of the hormone, as well as generics of other high-priced prescription drugs.

    Drug pricing experts welcomed the Eli Lilly news, predicting the move won’t undercut those efforts. And these other initiatives to bring lower-cost insulin to market, in turn, would put pressure on Eli Lilly to keep its prices down. Together these will help, not hamper, what could become a race to the bottom on insulin prices.

    “The more competition, the more stable this solution will be so that five to 10 years from now the prices won’t go up again,” said Dr. Vincent Rajkumar, a Mayo Clinic oncologist who has been a critic of high drug costs.

    The pressure could cause further ripples. Following Eli Lilly’s news, Sen. Bernie Sanders (I-Vt.) sent letters to the two other major insulin makers, Sanofi and Novo Nordisk, calling on them to follow suit.

    People with diabetes, especially those with Type 1 who need the drug to survive, will benefit. Yet even while some of Eli Lilly’s persistent critics praised the move, they noted work remains to make insulin widely affordable.

    “Additional competition and other accountability moves are still incredibly necessary because the companies can raise their list price again at any time,” said Elizabeth Pfiester, founder of T1International, a nonprofit that advocates for people with diabetes. “That’s why the government also needs to regulate insulin manufacturers to hold them accountable.”

    Cuban’s company did not respond to requests for comment on how the Eli Lilly cuts might affect its efforts. But Civica’s plan remains unchanged following the news, said spokesperson Debbi Ford.

    “From the beginning, we have said we are not entering medicine markets for market share,” Ford said. “We are participating for market impact.”

    Democratic California Gov. Gavin Newsom tweeted Wednesday that “sky high prices for insulin have put it out of reach for too many” and his state will manufacture its “OWN insulin and ensure all who need access to this medicine” can afford it.

    “Now, Eli Lilly is lowering their cost,” Newsom wrote. “Let’s keep it up.”

    Last year, California lawmakers approved $100 million for the state to contract for cheaper insulin and make the lifesaving drug, cutting out drugmakers and go-between companies that add to the price consumers pay. Newsom has said that California’s insulin would be available “at a cheaper price, close to at cost.” Officials haven’t said when the state’s insulin will be available, though, or exactly how much it will cost.

    “California’s goal was to get competition into the market however they can manage it,” said Robin Feldman, a professor at the University of California College of the Law-San Francisco who studies the insulin market. “If California’s entry results in bringing prices down from other manufacturers, that will be a good thing.”

    Eli Lilly’s price cuts apply to what it described as its “most commonly prescribed” insulins, but Feldman noted those are older insulin products. Although California officials haven’t released details about which insulin products would be included in its program, Feldman said she expects the state will offer a variety to cover the market.

    “It’s not aimed at any one company or any one drug,” she said. “It’s aimed at making affordable insulin available to market and putting pressure on other companies.”

    Washington and Maine are also exploring ways to bring cheap insulin to consumers, and large insurance companies pledged millions in an agreement with Civica to manufacture cheaper insulin.

    The cadre of newcomers aim to break open the insulin market because three pharmaceutical companies — Eli Lilly and Co., Sanofi, and Novo Nordisk — have long dominated the U.S. insulin supply and allowed their prices to escalate. The price of one of Eli Lilly’s products, for example, rose from $21 to $255 per vial between 1996 and 2016.

    St. Louis University law professor Dr. Michael Sinha said Eli Lilly may have seen a threat from the discount insulin initiatives.

    “This might be a response to some of those initiatives and the looming threat of really steep losses in terms of market share,” Sinha said.

    University of California-San Diego pharmaceutical professor Inmaculada Hernández offered another possible reason for the price cut: changes to how drugs are paid for by Medicaid.

    Beginning in 2024, Hernández said, drugmakers could be on the hook to pay fees, known as rebates, to Medicaid for drugs like insulin that have had steep price hikes. By lowering the list price of insulin, Eli Lilly could avoid those costs, Hernández said.

    Hernández said that understanding the incentives behind Eli Lilly’s decision to cut list prices could help lower the price of other drugs that patients have trouble affording. If the makers of those other drugs also slash their list prices ahead of 2024, it could show the effectiveness of the new federal policy. If they don’t, it might underscore the importance of factors unique to insulin like public pressure by politicians and activists or market competition from initiatives like California’s.

    This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

    KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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    Bram Sable-Smith and Samantha Young

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  • Eli Lilly and Company Is Lowering Insulin Prices | Entrepreneur

    Eli Lilly and Company Is Lowering Insulin Prices | Entrepreneur

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    Drug manufacturer Eli Lilly and Company, one of the major three in the U.S. that sells insulin, said it would cut prices by significant amounts and increase the ability to access one of its programs that limits costs out of pocket for insulin to $35 a month.

    “Lilly is taking these actions to make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system that may keep them from getting affordable insulin,” the company wrote in the Wednesday press release.

    The cost of insulin has been a major issue in the U.S., a country that generates 50% of revenue from insulin despite making up just 15% of the worldwide market, per a 2015 study published in The Journal of the American Medical Association (JAMA) Network. Insulin manufacturers in the U.S., have been, as one 2020 study put it, “insulated” from competition due to regulatory barriers and intellectual property issues.

    People have died while rationing insulin they could not afford. List prices of insulin from 2007 to 2018 increased by 262%, per a study published in the JAMA in 2020. Over eight million people need insulin to survive, per the American Diabetes Association.

    Eli Lilly and Company faced controversy in November 2022 when, in the wake of Elon Musk’s purchase of Twitter and overhaul of the verification process, an account posing as the company Tweeted insulin would be free, sending the company’s stock plunging.

    Related: Eli Lilly Stock Plummets After Parody Twitter Account Says Insulin is Now Free

    On Wednesday, the company said it would take several actions to reduce insulin prices. Its non-branded insulin, Insulin Lispro Injection’s list price will be cut to $25 per vial.

    Humalog and Humulin’s list prices will go down by 70% by the fourth quarter of 2023, it added. The company further said the newer drug Rezvoglar would cost $92 for a five-pack, effective April 1, 2023.

    Finally, the company outlined how it will limit out-of-pocket costs: “Effective immediately, Lilly will automatically cap out-of-pocket costs at $35 at participating retail pharmacies for people with commercial insurance using Lilly insulin,” the company wrote.

    However, according to the footnote, the company says this will be at the “majority of retail pharmacies.” It will not cover people who are on federal government insurance programs due to “government restrictions” (but the law already does require that people who have Medicare Part D, Medicare’s prescription drug benefit, pay no more than $35 a month for insulin, as the company noted).

    The company said people without insurance “can continue to go to InsulinAffordability.com and immediately download the Lilly Insulin Value Program savings card to receive Lilly insulins for $35 per month.”

    Insulin companies have faced lawsuits over the price of insulin, but Eli Lilly maintains the average out-of-pocket cost for someone purchasing insulin is $21.80, per The New York Times.

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    Gabrielle Bienasz

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  • Biosimilars May Finally Stop the Rocketing Cost of Insulin

    Biosimilars May Finally Stop the Rocketing Cost of Insulin

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    Oct. 26, 2022 – Trapper Haskins, a 45-year-old musician with type 1 diabetes, says the price of insulin is a constant stressor in his life. The Nashville resident takes two types of insulin daily and sometimes must ration the medicine because his insurance plan caps how much of the pricey drug he can receive each month. Insulin “isn’t like a high blood pressure medication,” he says. “Some days you need more, and then you get to the end of the month and you’re afraid you’ll run out.” 

    Research shows that among people with type 1 and type 2 diabetes, about one in four must ration their supplies due to cost. In general, most people with diabetes need two or three vials of insulin a month. Each vial can cost hundreds of dollars, meaning patients’ costs could easily reach $1,000 a month.  

    “The price of insulin has tripled in the last 10 years, and it’s creating a national crisis,” says Lizheng Shi, PhD, a professor of health policy at Tulane University in New Orleans.          .

    There are 1.5 million people with type 1 diabetes in the U.S. who can’t buy their own insulin and are entirely dependent on it to keep their blood sugar in a safe range. The vast majority of people with diabetes, some 37 million, have type 2 diabetes, which usually results in the use of blood sugar-reducing medications until insulin is introduced later on because the body no longer responds to its own. 

    The high cost of insulin is largely due to a lack of competition and too few makers of the current products, says Shi. One of the best hopes for more affordable insulin is to increase market competition and drive down prices with the introduction of so-called biosimilar drugs, which are highly similar versions of the original biologic medications – and typically far less expensive. 

    Creating Competition in the Market 

    In July 2021, the FDA approved the first biosimilar product that could be used interchangeably with current insulin products. Called Semglee, it’s a long-acting insulin analog and the generic form of Lantus, the world’s leading basal insulin, whose patent expired in 2016. Semglee, which is made by the drug company Mylan, is now available under some 2022 insurance plans and is approved for patients with type 1 and type 2 diabetes. But Semglee isn’t inexpensive – it’s around $133 per vial without insurance. Some versions of Lantus retail for more than $300. 

    The introduction of insulin biosimilars won’t bring major price cuts anytime soon,  says Jing Luo, MD, an assistant professor of medicine at the University of Pittsburgh. One reason, he says, is that it takes years for drugmakers to develop  the expertise and capacity to scale up production of biosimilars. Still, Luo is optimistic that we’ll get there in the next 2-3 years, and once we do, it could mean insulin would cost 10 times less. 

    Luo cites  the work of the nonprofit Civica Rx. In March, the organization announced it would produce large-scale generic insulin in an effort to drive down cost. 

    The company will produce three forms of insulin to be used interchangeably with Lantus, Humalog, and Novolog. The products will be sold for no more than $30 a vial. They’ve already started building their manufacturing plant in Petersburg, VA, and will have products available for purchase by 2024, pending FDA approval.

    Additionally, the state of California plans to produce its own generic insulin. The state is investing $50 million to make biosimilar insulin products and another $50 million to build a manufacturing facility. 

    Not Soon Enough

    But for many, price cuts aren’t happening fast enough. Allison Bailey of Ames, IA, who has type 1 diabetes, says that it can feel daunting sometimes to find a way to pay, but she couldn’t survive without the life-saving medication. At times, it’s cost her up to $500 to fill her prescription. Bailey was eventually able to adjust her prescription to a less expensive insulin, but the 35-year-old graphic designer says her insurance coverage still takes up a sizable chunk of her monthly expenses.

    The introduction of biosimilars has not driven down the price of insulin fast enough for patients like Bailey, says Robert A. Gabbay, MD, PhD, chief science and medical officer at the American Diabetes Association. That’s why the association is pushing legislation to bring down insulin prices. It lobbied hard to establish a $35-per-month Medicare price cap that will go into effect in 2023. Now it’s focused its efforts on expanding the caps to private insurers, a move that was voted down by Republicans in Congress as part of the Inflation Reduction Act. 

    “We want to see some transparency in pricing; right now, everyone just points fingers at each other and we don’t know who’s to blame,” Gabbay says. 

    But people with diabetes like Haskins and Bailey agree that competition from biosimilars and price caps could help bring down what they view as the exorbitant prices for medications they need. “I’m lucky I have insurance, but for those who don’t, it’s often a life-or-death situation,” says Haskins

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  • Lowering the Cost of Insulin Could Be Deadly

    Lowering the Cost of Insulin Could Be Deadly

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    When I heard that my patient was back in the ICU, my heart sank. But I wasn’t surprised. Her paycheck usually runs short at the end of the month, so her insulin does too. As she stretches her supply, her blood sugar climbs. Soon the insatiable thirst and constant urination follow. And once her keto acids build up, her stomach pains and vomiting start. She always manages to make it to the hospital before the damage reaches her brain and heart. But we both worry that someday, she won’t.

    The Inflation Reduction Act, passed last month, aims to help people like her by lowering the cost of insulin across America. Although efforts to expand protections to privately insured Americans were blocked in the Senate, Democrats succeeded in capping expenses for the drug among Americans on Medicare at $35 a month, offering meaningful savings for our seniors, some of whom will save hundreds of dollars a month thanks to the measure. In theory, the policy (and similar ones at the state level) will help the estimated 25 percent of Americans on insulin who have been forced to ration the drug because of cost, and will prevent some of the 600 annual American deaths from diabetic ketoacidosis, the fate from which I’m trying to save my patient.

    Indeed, laws capping co-payments for insulin are welcome news both financially and medically to patients who depend on the drug for survival. However, in their current version, such laws might backfire, leading to even more diabetes-related deaths overall.

    How could that be true? Thanks to the development of new drugs, insulin’s role in diabetes treatment has been declining over the past decade. It remains essential to the small percent of patients with type 1 diabetes, including my patient. But for the 90 percent of Americans with diabetes who have type 2, it should not routinely be the first-, second-, or even third-line treatment. The reasons for this are many: Of all diabetes medications, insulin carries the highest risk of causing dangerously low blood sugar. The medication most commonly comes in injectable form, so administering it usually means painful needle jabs. All of this effort is rewarded with (usually unwanted) weight gain. Foremost and finally, although insulin is excellent at tamping down high blood sugar—the hallmark of diabetes and the driver of some of its complications—it is not as impressive as other medications at mitigating the most deadly and debilitating consequences of the disease: heart attacks, kidney disease, and heart failure.

    Read: People are clamoring to buy old insulin pumps

    Large clinical trials have shown that two newer classes of diabetes medicines, SGLT2 inhibitors and GLP-1 receptor agonists, outperform alternatives (including insulin) in reducing the risk of these disabling or deadly outcomes. Giving patients these drugs instead of older options over a period of three years prevents, on average, one death for about every 100 treated. And SGLT2 inhibitors and GLP-1 receptor agonists pose less risk of causing dangerously low blood sugar, generally do not require frequent injections, and help patients lose weight. Based on these data, the American Diabetes Association now recommends SGLT2 inhibitors and GLP-1 receptor agonists be used before insulin for most patients with type 2 diabetes.

    When a young person dies from diabetic ketoacidosis because they rationed insulin, the culprit is clear. But when a patient with diabetes dies of a heart attack, the absence of an SGLT2 inhibitor or GLP-1 receptor agonist doesn’t get blamed, because other explanations abound: their uncontrolled blood pressure, the cholesterol medication they didn’t take, the cigarettes they continued to smoke, bad genes, bad luck. But every year, more than 1,000 times more Americans die of heart disease than DKA, and of those 700,000 deaths, a good chunk are diabetes-related. (The exact number remains murky.) Diabetes is a major reason that more than half a million Americans depend on dialysis to manage their end-stage kidney disease, and that about 6 million live with congestive heart failure. The data are clear—SGLT2 inhibitors and GLP-1 receptor agonists could help reduce these numbers.

    Still, uptake of these lifesaving drugs is sluggish. Only about one in 10 people with type 2 diabetes is taking them (fewer still among patients who are not wealthy or white). The main cause is simple and stupid: American laws prioritize profits and patents over patients. Because SGLT2 inhibitors and GLP-1 receptor agonists remain under patent protections, drug companies can charge exorbitant rates for them: hundreds if not thousands of dollars a month, sometimes even more than insulin. Doctors spend hours completing arduous paperwork in the hopes of persuading insurers to help our patients, but we’re frequently denied anyway. And even when we do succeed, many patients are left with painful co-payments and deductibles. The most maddening part is that despite their substantial up-front expense, these medications are quite cost-effective in the long run because they prevent pricey complications down the road.

    Read: The risks of over-the-counter diabetes treatments

    This is where addressing the cost of insulin—and only insulin—becomes problematic. Doctors are forced daily to decide between the best medication for our patients and the medication that our patients can afford. Katie Shaw, a primary-care physician with a bustling practice at Johns Hopkins, where I’m a senior resident, told me that plenty of her patients can’t afford SGLT2 inhibitors and GLP-1 receptor agonists. In such instances, Shaw is forced to use older oral alternatives and occasionally insulin. “They’re better than nothing at all,” she said.

    If the cost of insulin is capped on its own, insulin will be more likely to jump in front of SGLT2 inhibitors and GLP-1 receptor agonists in treatment plans. That will mean more disease, more disability, and more death from diabetes.

    Medicare patients might avoid some of these effects thanks to provisions in the IRA allowing Medicare to negotiate drug prices and capping out-of-pocket spending on prescriptions at $2,000 a year. The law also guarantees price negotiations for a handful of medications, but SGLT2 inhibitors and GLP-1 receptor agonists won’t necessarily be on the list. And most Americans are not on Medicare. Already, Shaw said, the patients in her practice who tend to be least able to afford SGLT2 inhibitors and GLP-1 receptor agonists are working-class people with private insurance. Some health centers, including the one Shaw and I work at, enjoy access to a federal drug-discount program that can make patent-protected medications, including SGLT2 inhibitors and GLP-1 receptor agonists, more affordable for the uninsured. But most Americans without insurance aren’t so lucky.

    It would be cruel to choose between a world in which more people with type 2 diabetes are nudged toward a drug that won’t stave off the most dangerous complications, and one in which those with type 1 diabetes are priced out of life. In place of capping the out-of-pocket cost of just insulin, lawmakers should cap the out-of-pocket cost of all diabetes medications. This will both protect Americans dependent on insulin and smooth SGLT2 inhibitors’ and GLP-1 receptor agonists’ path to their revolutionary public-health potential.

    Read: Big Pharma’s go-to defense of soaring drug prices doesn’t add up

    The argument for lowering the cost of these drugs for patients is the same as the argument for insulin affordability: that it is both foolish and inhumane to make lifesaving diabetes medications unaffordable when their use prevents costly and deadly downstream complications.

    Patients like mine need affordable access to insulin. But even more need access to SGLT2 inhibitors and GLP-1 receptor agonists. If the laws stop at insulin, many Americans could die unnecessarily—not from inadequate access to insulin, but from preferential access to it.

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    Michael Rose

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