Skyrocketing Charges for Insulin Should Be a Crime

Conventional medicine still has Type 2 diabetes misidentified as a blood sugar problem. In reality, the condition is rooted in insulin resistance and faulty leptin signaling, caused by chronically elevated insulin and leptin levels. In other words, it’s a diet-derived condition that can be reversed using a cyclical ketogenic diet and fasting.

This is why the medical community’s approach to Type 2 diabetes treatment, which typically involves the administration of insulin, is fatally flawed and professionally irresponsible. Treating Type 2 diabetes with insulin is actually one of the worst things you can do, as it simply accelerates dying from the disease.

Type 1 diabetics, on the other hand, do require a steady supply of insulin for their survival, as their bodies produce little or no insulin at all. Previously called juvenile diabetes, there are actually more adults with Type 1 diabetes than there are children with the condition, with an estimated 1 million to 1.5 million Type 1 diabetics in the U.S. alone.

Type 1 diabetes is an autoimmune disease in which your immune system attacks and destroys your pancreatic cells that produce insulin, which is why it’s also referred to as insulin-dependent diabetes. Tragically, as prices of insulin have skyrocketed, many Type 1 diabetics are now risking their lives by rationing their insulin use.1

Skyrocketing Costs Force Type 1 Diabetics to Risk Their Lives

In a recent article,2 The Washington Post tells the story of Alec Raeshawn Smith, who was diagnosed with Type 1 diabetes in 2015, just shy of his 24th birthday. Two years later, his health insurance coverage under his mother’s policy expired, leaving him with two expensive options: Get his own insurance, which would cost about $450 per month with a $7,000 deductible, or pay for his diabetic supplies out of pocket. The Washington Post continues:

“What Alec soon learned was just how much his insulin would end up costing… The price of insulin — once modest — has skyrocketed in recent years, making the lifesaving medication a significant, even burdensome, expense, especially for the uninsured and underinsured.

The costs are so heavy that they have driven some patients to ration their supplies of the drug in a dangerous gamble with life-threatening consequences. At the time Alec discussed skipping insurance coverage, he told his mother, ‘It can’t be that bad.’ Within a month of going off her policy, he would be dead …

As Nicole [Alec’s mother] cleaned out his cluttered blue car, littered with old prescription receipts, she started to cobble together just how much his insulin and blood sugar testing supplies cost without insurance or discounts. The total, by her count, was nearly $1,300 per month …

That $1,300 was almost $200 more than Alec’s biweekly paycheck. Nicole now believes that Alec was rationing his insulin because of the cost … ‘We realized that he had been taking less insulin and less often than he should, trying to make it stretch until he got his next paycheck.’ He was found dead three days before payday.”

Price Gouging Insulin Should Be a Crime

As noted in the featured article,3 the three researchers (Frederick Banting, Charles Best and James Collip4) who in 1921 discovered insulin — thereby transforming diabetic treatment and offering hope for a more or less normal life for Type 1 diabetics, who were previously doomed to die young — sold their patent to the University of Toronto for $1 each.

According to historian Michael Bliss,5 these researchers were trying to provide a great humanitarian gift to the world. In the hands of drug companies, however, insulin has become a guaranteed profit center totally isolated from the inventors’ benevolent intentions for the use of their discovery.

The price of insulin tripled between 2002 and 2013,6,7 and has doubled again since.8 At present, the three dominant makers of insulin, Eli Lilly, Sanofi and Novo Nordisk — which control 96% of the insulin market9 — all sell their insulin for approximately the same prices, and have raised them in lockstep, raising suspicions of price fixing.10

Drug makers also continue fine-tuning their formulas to prevent low blood sugar episodes, and while that’s good, it also ensures the drug patents don’t expire, preventing generics from being introduced.11

“For decades, manufacturers improved formulas, first using animal parts, then producing human insulin using bacteria and recombinant DNA. The 1990s saw the advent of insulin analogs, synthetic drugs made to better mimic the body’s own insulin production,” The Washington Post writes.12

“Today, critics argue that the price of insulin has far outpaced any innovations … In 1996, when Eli Lilly debuted its Humalog brand of insulin, the list price of a 10-milliliter vial was $21. The price of the same vial is now $275. Those costs can be compounded by the multiple vials that diabetics may require to survive each month.”

Price Hikes Threaten Insulin-Dependent Americans’ Lives

The Washington Post13 cites IBM Watson Health data showing Sanofi’s Lantus brand went from $35 per vial when introduced in 2001 to about $270 today, and Novolog, by Novo Nordisk, which started out at $40 per vial when released in 2001, now sells for around $289.

According to a 2016 JAMA study,14,15 the nondiscounted price for Lantus in the U.S. in 2015 was as high as $372.75, and the discounted price $186.38. Meanwhile, that same drug sold for $67 in Canada, $60.90 in Germany and $46.60 in France.

Even more telling is a 2018 study16 showing the estimated cost of manufacturing a 12-month supply of analog insulin is between $78 and $133 per patient, and $48 to $71 per patient per year for biosimilars. Why are patients having to pay as much as $24,000 a year for insulin that costs less than $133 to manufacture?

In response to growing outcry and lawsuits over insulin prices, Eli Lilly introduced Lispro, a less expensive generic version of its insulin Humalog, in May 2019.17,18 Lispro is said to sell at about half of the list price of Humalog.

According to a company statement,19 “The people who are most likely to benefit from Insulin Lispro Injection are Medicare Part D beneficiaries, people with high-deductible health plans and the uninsured who use Humalog.”

Lack of Competition, Payment Incentives Drive Prices

Why the dramatic increase in insulin prices? A November 2018 congressional caucus report,20,21 “Insulin: A Lifesaving Drug Too Often Out of Reach,” sought to identify the reasons behind these literally life threatening price hikes. As noted in this report:22

“Every day 7.5 million Americans rely on insulin [my note: over 6 million of these are Type 2 diabetics and should not be taking insulin] to manage their blood sugar levels and prevent debilitating, even deadly complications.

This lifesaving drug, however, has become increasingly unaffordable. Its average price has nearly doubled since 2012, putting an enormous financial burden on millions of patients.

For more than a year, Representatives Diana DeGette (D-CO) and Tom Reed (R-NY), the co- chairs of the Congressional Diabetes Caucus, have conducted a bipartisan inquiry to uncover the sources of this dramatic price increase.

This culminating report provides an overview of the insulin supply chain, discusses the drivers behind rising insulin prices, and recommends policy solutions to lower costs …

Many of the complicating reasons will be detailed further in this inquiry, including the myriad steps that insulin takes from manufacturer to patient, the perverse payment incentives and methodologies, the lack of transparency in pricing and outdated patent regulations, among other things.

These market failures have allowed a handful of players along the insulin distribution pipeline from manufacturers to health insurers to capitalize on their strategic positions, driving up the price of insulin and minimizing competition.

Congress should pursue a handful of legislative actions to increase price transparency, promote competition among insulin makers, and encourage the use of value-based contracts. Congress should also consider working on targeted patent reforms to prevent anti-competitive practices and streamline the drug approval process at the Food and Drug Administration for biosimilar insulins.”

While 1 in 4 patients gambles with their lives by rationing their insulin supplies by what they can afford,23 others have taken to illegally importing insulin from other countries where prices are more reasonable.

The Washington Post24 recounts testimony from one father who told senators a 90-day supply of insulin for his son costs $1,489.46 through insurance with a high deductible. He’s resorted to buying insulin from a Canadian pharmacy, from which he can get the same amount of insulin for $350 including shipping.

According to the article, while this is technically illegal, “the Food and Drug Administration generally doesn’t prosecute individuals if it’s a short-term supply for personal use.”25 Many others have turned to GoFundMe to raise donations for their insulin purchases.

Why Rationing Your Insulin Is a Dangerous Gamble

For Type 1 diabetics, whose bodies can’t make insulin, getting a steady supply is crucial for their health. Taking lower doses, or skipping doses, can be immediately life threatening and in the long term can result in even more costly health problems. As noted in the featured article:26

“Poor glycemic control can lead to blindness, kidney failure, amputation, heart disease and stroke. In the short term, patients who stop taking enough insulin can lapse into diabetic ketoacidosis, a condition where blood sugars get too high and the body’s blood becomes acidic. It can become fatal in just hours or a few days.”

While not an ideal solution, The Washington Post points out an alternative solution: older versions of insulins, available at Walmart for approximately $25 per vial.

While there’s some evidence showing these older formulas, which came out in the 1980s, are more likely to trigger dangerously low blood sugar and are typically thought to be safer for Type 2 diabetics than Type 1 diabetics, the doctors interviewed by The Washington Post agree it’s better than nothing.

Similarly, in the information sheet, “Diabetes Meds on a Budget,”27 Beverly Thomassian, a registered nurse and president of Diabetes Education Services, points out:

“The older insulins are regular and NPH. They are available as Humulin R and N (Eli Lilly) and Novolin R and N (Novo Nordisk). These biosynthetic insulins take longer to start working and the NPH peaks at 4 – 10 hours.

ReliOn Brand — Walmart sells Novolin insulin Regular, NPH and 70/30 (biphasic insulin) under the ReliOn label at discounted prices … Newer insulins are referred to as analogues. The amino sequence of these insulins has been slightly rearranged through genetic engineering to make them more rapidly available or take longer to absorb …

Given these pricing disparities, please consider reading this article28 published in Diabetes Care, 2009 — that describes the effective use of NPH and Reg to manage Type 2 diabetes.

The authors research shows that for type 2s, NPH and Regular insulins are as effective as the newer analogues in getting glucose to goal. The main drawbacks are well known; the peak of NPH slightly increases risk of hypoglycemia and patients will get better post prandial glucose control by taking regular insulin 30 minutes before meal (vs at meals with the analogs).”

Insulin Makers Sued

As mentioned, the surprisingly similar price hikes by all three makers of insulin have raised suspicions that the companies are in collusion. It wouldn’t be the first time. In February 2010, Mexico fined Eli Lilly and three Mexican drug companies $1.7 million each for colluding to eliminate competition by agreeing to take turns in placing winning bids for insulin, thereby artificially raising prices.29

In January 2017, a class action lawsuit30 was filed against Sanofi, Novo Nordisk and Eli Lilly in Massachusetts federal court, claiming the companies are in violation of the Racketeer Influenced and Corrupt Organizations Act.31 The New York Times reported:32

“The lawsuit … accuses the companies of exploiting the country’s opaque drug-pricing system in a way that benefits themselves and the intermediaries known as pharmacy benefit managers.

It cites several examples of patients with diabetes who, unable to afford their insulin treatments, which can cost up to $900 a month, have resorted to injecting themselves with expired insulin or starving themselves to control their blood sugar.

Some patients, the lawsuit said, intentionally allowed themselves to slip into diabetic ketoacidosis — a blood syndrome that can be fatal — to get insulin from hospital emergency rooms.”

In October 2018, the attorney general of Minnesota, Lori Swanson, also filed a lawsuit against the three insulin makers, charging them with deceptive and misleading price increases.33 As reported by The Hill:34

“The lawsuit alleges that there is a deceptive difference between the sticker price of these insulins and the actual price that insurers pay after negotiators known as pharmacy benefit managers (PBMs) get discounts.

The attorney general says drug companies are raising the sticker price ever higher so that they can give larger discounts to the PBMs, which helps them secure more favorable coverage of their products relative to their competitors in insurance plans.

The problem, Swanson says, is that the spiking sticker prices hurt people who don’t have insurance or who have high deductibles they have to pay before insurance kicks in.

‘The lawsuit alleges that the list prices the drug companies set are so far from their net prices that they are not an accurate approximation of the true cost of insulin and are deceptive and misleading,’ the attorney general’s office says.”

Biohackers Make Their Own Insulin

Aside from rationing, extended fasting, insulin sharing, using expired insulin, setting up GoFundMe campaigns or illegally importing insulin from other countries, some Type 1 diabetics are taking insulin production into their own hands.

In a recent Elemental Medium article,35 Dana Smith talks about the Open Insulin Project, “a biohacker collective that is trying to produce the lifesaving drug and provide it to people with diabetes for free, or close to it.” She writes:

“The group was founded in 2015 by Anthony Di Franco, a computer scientist with Type 1 diabetes, and a longtime member of the California hacker scene … He and his collaborators think one solution to the pricing crisis lies in enabling patients and hospitals to create insulin themselves.

The group works out of Counter Culture Labs in the trendy Temescal neighborhood of Oakland … ‘If we can make this stuff in our janky lab on a $10,000 a year budget, there’s no way it should cost this much,’ says Thornton Thompson, a molecular biologist who is part of Open Insulin.

‘One of the big goals of the project is just to demonstrate that.’ Scientists make insulin by inserting a gene that codes for the insulin protein into either yeast or bacteria. These organisms become mini bio-factories and start to spit out the protein, which can then be harvested, purified, and bottled.

Scientists at Genentech were the first to synthesize insulin this way back in 1979 from the bacterium E. coli, and drug manufacturers have been using the method ever since. Open Insulin’s goal is to develop a similar way to generate insulin that doesn’t infringe on any patents and can be made publicly available.”

The Open Insulin Project

To produce insulin, the group uses yeast rather than E. coli. A French biochemist named Yann Huon de Kermadec joined the Open Insulin Project about a year-and-a-half ago. He took charge of the manufacturing process and obtained the appropriate insulin gene, which is then inserted into the DNA of the yeast, thereby producing a small amount of insulin protein.

They’ve not yet been able to extract high-enough amounts to move on to the purification stage, so at present they’re still working on increasing the yield. “If they succeed, they will go through the final steps of purifying and testing the protein. Once they’re confident that what they’ve produced really is pure insulin, Di Franco will serve as the group’s first guinea pig,” Smith writes.

According to Open Insulin, 10 liters of yeast culture are enough to make insulin for 10,000 individuals, with a startup cost as low as $1 per person. Indeed, as noted earlier, insulin manufacturing is pretty darn inexpensive — at most around $133 per person per year for an analog, and as low as $48 per person per year for a biosimilar.

Once a well-working insulin has been developed, the group hopes to make the recipe open-source, allowing hospitals and other patient groups make it for themselves. Thompson told Smith:

“What we’re interested in medium- and long-term is to try to organize networks of production and distribution centers that work by a fundamentally different model. We want to partner with hospitals, free health care clinics, patient organizations, diabetes groups. What if you could set up a small-scale production center in the back of a hospital?”

Di Franco adds, “Economically, I think it’s much better to do it in this decentralized way. A very small investment from each patient could fulfill the patient’s needs and make insulin very close to free for everyone who needs it with this kind of technology.”

As you’d expect, others are less than excited about such a prospect, not because it would create much-needed competition, but because of safety concerns. For example, Dr. Eric Topol, chair of innovative medicine and executive vice president at the Scripps Research Institute, told Smith:

“There are so many things that could go wrong in the process: the sterilization, the efficacy, the safety. It’s like Murphy’s law, here. These are potent drugs that can have serious side effects. I just don’t see that that is a safe or practical route.”

Millions of Americans Get Their Medications Outside the US

At present, there are no easy solutions for insulin-dependent diabetics. What’s clear is that it shouldn’t cost thousands of dollars a month for an essential drug required to keep these people alive.

If you’re in this boat, consider talking to your doctor about the possibility of using the older biosynthetics, Humulin R and N, or Novolin R and N, available for about $25 at Walmart. It may not be ideal (you can read about some of the concerns in this Insulin In Nation article36) but it’s probably still better than nothing. Even better, however, especially for Type 1 diabetics, is getting your insulin from overseas — or even just next door, north or south of the U.S. border.

Research published in 2015 shows that 952,000 Californians cross into Mexico every year for lower-priced health care, including prescription drugs.37 From the northern border, a random survey of Americans showed that 8% of respondents or someone they knew had imported their medications from Canada.

In numbers, that adds up to 19 million individuals — with estimates that the numbers are probably much higher — crossing into Canada just to be able to afford medications they may very well not be able to live without.38 But is this legal? And if it is, how do you do it? And if you’re not near the southern or northern U.S. borders, is there anywhere else to go? According to the FDA:

“In most circumstances it is illegal for individuals to import drugs or devices into the U.S. for personal use because … [they] have not been approved for use or sale in the U.S. … The FDA cannot ensure the safety and effectiveness of medicine purchased over the internet from foreign sources, storefront businesses that offer to buy foreign medicine for you, or during trips outside the U.S.”

The FDA does make exceptions for certain medications under specific situations, but even so, the amounts can’t be for more than a three-month supply. That said, Kaiser Health Network39 reports that personal use purchases for drugs not considered a risk by the FDA — such as insulin — in 90-day supplies are not being prosecuted.

And just how much are Americans saving by crossing the border? Kaiser Health gave an example of a woman vacationing in Canada who visited a local pharmacy for an emergency insulin refill for her daughter: The pack of insulin pens, which cost $700 in the U.S., was a mere $65.

The same box costs $73 in Germany; $57 in Israel; $51 in Greece; $61 in Rome and $40 in Taiwan. It’s no wonder millions of Americans are getting prescriptions by mail order overseas! Yet, even though they’re not prosecuting people for it, the FDA is clamping down on mail orders by going after them at international mail facilities.

According to online journalism group Tarbell,40 the FDA intercepted 10,731 prescription drug packages in 2017; by May 2018, they’d confiscated 19,318. Their goal is to intercept 100,000 a year.

So, what can you as a consumer do, if you can’t afford the outrageous — bordering on criminal — pricing and you’re not brave enough to test the system and try to take a vacation out of the country or order by mail? One way to begin could be to study the FDA’s personal importation guidelines to see if there is some way you can qualify for an exception so you can get your insulin from out of the country legally.

Guidelines for Insulin-Dependent Diabetics

Also remember that your lifestyle will have an impact on your blood sugar control. Ways to help manage your glucose levels include the following. Just be sure to consult your physician before making any drastic changes to your lifestyle habits and dietary plan, to avoid wild blood sugar fluctuations.

Limiting your net carb intake (total carbs minus fiber) — When you eat high-carb foods, your body converts the starches and sugars into glucose, which will enter your bloodstream and increase your blood glucose levels. Make sure you monitor your carbohydrate intake to avoid hyperglycemia.
Timing your meals appropriately — Meal timing is crucial to the treatment and management of Type 1 diabetes, since it may affect the efficiency of your insulin intake. The best time to eat your meal depends on the type of insulin that you’re taking. For example, regular insulin should be taken 30 minutes before a meal.41
Eating only nutritious foods — Avoid eating foods that contain sugar, preservatives, trans fat, refined flour and other unhealthy ingredients. Rather, fill your plate with wholesome foods rich in vitamins and minerals. You should also consume foods that are high in healthy fats and probiotics, since these may help you gain better control of your blood glucose levels.
Exercising regularly — Following an active lifestyle will help regulate your blood sugar levels, as it allows your body to use insulin more efficiently, and can help you avoid long-term complications associated with Type 1 diabetes, such as heart disease.42

Read more: articles.mercola.com

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