Posts Tagged ‘Insulin’

Updates On Recent Stories I Covered

Friday, March 3rd, 2023

Israel’s judicial crisis continues as far right bills advance in Knesset

In mid-February I wrote about Israel’s descent into judicial chaos.

Israel had gone through three elections in late 2022 to elect a new government. To regain power, the historically conservative Likud Party, headed by Benjamin Netanyahu, joined in a coalition with five right-wing and religiously conservative parties, some of which are hugely influenced, perhaps dominated, by Israel’s ultra-Orthodox community, known as the Haredim. The coalition won the third election, and Netanyahu became Prime Minister for the sixth time. Six days after the election the government filed bills in the Israeli parliament, the Knesset, to severely limit the power of the country’s Supreme Court in that:

  1. A simple majority in the Knesset, 61 votes out of 120, would have the power to annul Supreme Court rulings. This would enable the government of the day to pass legislation without fear of it being struck down. It is called the “override” provision, in that the Knesset could override a Supreme Court ruling;
  2. The Supreme Court’s ability to revoke administrative decisions by the government on the grounds of “reasonability” (what would a reasonable person say about this?), would end, significantly decreasing judicial oversight; and,
  3. For the Supreme Court to strike down a Knesset-passed law would require 80% of the court’s 15 judges voting for such a ruling. But even if that were to happen, a simple Knesset majority could “override” the ruling.

At the time I wrote about this there was a singular complication: Benjamin Netanyahu is on trial, actually three trials, for corruption. If he is convicted of anything and appeals, the coalition government could override any Supreme Court ruling. Some might say this places Netanyahu at the mercy of his coalition partners.

Update

In order for these measure to become law requires passing three readings in Knesset committees. Last week, in a long and tense plenary session, the combined bill passed its first reading in the Knesset. Yesterday, the Knesset’s Constitution Committee advanced the bill for its second reading.

The judicial crisis was only made worse last Sunday when, in revenge for the killing of two Jewish Israeli brothers as they drove through the West Bank town of Hawara, near the city of Nablus, a mob of Jewish settlers attacked the town, torching 36 homes and 15 cars. The Palestinian Red Crescent reported one death and 98 Palestinians wounded in the attack. Three ambulances were also destroyed.

The attack was met with a public outpouring of support from settler leaders and Knesset members. Moreover, the Israeli coalition Finance Minister, Bezalel Smotrich, a firebrand of the first order, told the settlers, “Hawara must be destroyed.” It nearly was.

The U.S. condemned the violence in unusually strong terms. “Just as we condemn Palestinian incitement to violence, we condemn these provocative remarks that also amount to incitement to violence,” State Department spokesperson Ned Price said.

It does not seem too much of a stretch to conclude the new coalition government, with its uber-nationalistic sway, has emboldened the highly nationalistic settlers who continue to gobble up land and force Palestinians into ever more woeful conditions.

Israel’s other western allies, for example the UK and France, have also condemned Sunday’s violence and, along with U.S. Secretary of State Antony Blinken, have told Mr. Netanyahu—to his face—that the judicial reforms he is championing are a serious threat to the future of their relationship. So far, the Prime Minister and his coalition partners are calling their bluff.

At this point, it does not appear this situation will end well—for anyone.

Mississippi extends Medicaid postpartum coverage duration

In February, I wrote about maternal mortality in America. Bottom line: It’s the highest in the developed world. At that time, I wrote:

Federal law requires Medicaid to cover postpartum care for only 60 days following birth, which is one of the prime reasons for our lagging maternal mortality global performance. In the other OECD countries, mothers not only receive postpartum care for a year, they also average 51 weeks of paid maternity leave. (The U.S. is the only OECD country with no requirement for paid maternity leave.)

The  American Rescue Plan Act of 2021 (ARPA) created an option for states to extend postpartum coverage for Medicaid beneficiaries from 60 days to a full year. Under the Act, the option was scheduled to expire in 2027. Under the Consolidated Appropriations Act of 2023, the 12-month extended Medicaid postpartum coverage option was made permanent. Now once states take up the option to extend the postpartum period from 60 days to 12 months, federal matching funds will continue to flow. Thus far, 35 states have already taken advantage of the option and the federal cash that goes with it.

Nine other states have legislation pending to follow the 35. Mississippi is one of them.

Update

I can’t tell you how happy I am to report that yesterday the Mississippi legislature passed the postpartum permanent extension, and Governor Tate Reeves signed it into law. Reeves had been opposed to the measure, but had a change of heart when he realized that a lot more babies were about to be born in Mississippi due to the repeal of Roe v. Wade and the state’s strict (to say the least) anti-abortion laws, which meant some mothers could die without the postpartum extension, and the politically astute Reeves did not want to be the one taking incoming fire for helping that to happen. To which I say: Whatever works.

Mississippi’s joining the postpartum extension club only happened because Division of Medicaid Executive Director Drew Snyder, whose department reports to the Governor and who for months has refused to take a stance on postpartum coverage extension (how medically courageous of him, eh?), wrote a letter on 27 February to House Speaker Philip Gunn voicing his newfound support for the legislation’s passage (notably, after his boss, Governor Reeves had his change of heart). Gunn had been vehemently opposed to the measure, believing it put the state in the awful position of expanding Medicaid under the Affordable Care Act, something he has vowed would never happen. In his letter, Snyder assured Gunn that permanently extending Medicaid postpartum coverage would not equate to expanding Medicaid a la the Affordable Care Act, and he urged the Speaker to come on board for all the reasons that had swayed Governor Reeves. You know, all those babies about to be born in Mississippi. He also reminded Gunn the state has a $3.1 billion surplus, the annual cost of the extension is pegged at $7.1 million, and the feds will chip in more than $35 million. Reading Snyder’s letter is like reading George Orwell.

Whatever the reasons, Mississippi has done the right thing.

Ely Lilly to drop the cost of basic insulin to $35 per vial

I have written a number of times about what I consider the obscene price of insulin for Type 1 diabetics. See here and here for the history of the discovery and how we got to this point. Bottom line, as I wrote in 2018, the three discovers of insulin, led by Frederick Banting, who won the Nobel Prize for it:

sold the patent to the University of Toronto for the princely sum of $3.00. When asked why he didn’t cash in on his discovery, Banting said, “Insulin is my gift to mankind.” With Banting’s blessing, the University licensed insulin’s manufacturing to drug companies, royalty free. If drug companies didn’t have to pay royalties, Banting thought they would keep the price of insulin low.

And they did. For decades.

But patents expire, and capitalism being what it is, people get greedy, and greed is why we have no generic, low-cost insulin today and why, over the past 20 years, insulin prices have risen anywhere from 800% to 1,157%, depending on the variety and brand. It’s why, lacking health insurance, some Type 1 diabetics have recently been driven to ration their precious insulin. Some of them have died.

Update

Yesterday, the Ely Lilly company, the first company to license Banting’s discovery, announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month. In its press release, the company said it is:

  • Cutting the list price of its non-branded insulin, Insulin Lispro Injection…to $25 a vial. Effective May 1, 2023, it will be the lowest list-priced mealtime insulin available, and less than the price of a Humalog® vial in 1999.
  • Cutting the list price of Humalog® …, Lilly’s most commonly prescribed insulin, and Humulin® (insulin human) injection … by 70%, effective in Q4 2023.
  • Launching RezvoglarTM …injection, a basal insulin that is biosimilar to, and interchangeable with, Lantus® (insulin glargine) injection, for $92 per five pack of KwikPens®, a 78% discount to Lantus, effective April 1, 2023.

Lilly also said:

  • Effective immediately, Lilly will automatically cap out-of-pocket costs at $35 at participating retail pharmacies for people with commercial insurance using Lilly insulin.
  • People who don’t have 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.

This, of course, is marvelous news for the 1.3 million Type 1 diabetics in the country not on Medicare, which already has a $35 cap thanks to the Inflation Reduction Act of 2022.

It is not an exaggeration to say insulin made Eli Lilly and Company and Novo Nordisk two of the top pharmaceutical companies in the world. It also hasn’t hurt the bottom line of Sanofi, the company that rounds out the insulin producing triumvirate and is the world’s fifth largest pharma by sales. I think it is a good bet these last two will quickly follow Lilly’s lead.

The greed of these three companies over the last two or three decades has hurt a lot of people, both physically and economically. Let’s hope this move by Lilly is the first step in making amends.

 

 

On Health, History And The Fine Art Of Fudging Data

Wednesday, August 10th, 2022

The cost of insulin, or, half a loaf is better than none

The Inflation Reduction Act (IRA), passed this past Sunday in the Senate and now sitting for certain passage in the House this week, will cap the cost of an insulin vial at $35 for Medicare beneficiaries with diabetes. However, for those not on Medicare, insulin costs will remain unchanged.

Of the 30 million Americans who have diabetes, more than 7 million of them require daily insulin. A Kaiser Family Foundation study released in July, 2022, found 3.3 million of the 7 million are Medicare beneficiaries  and documented the rise in insulin’s cost since 2007.

Aggregate out-of-pocket spending by people with Medicare Part D for insulin products quadrupled between 2007 to 2020, increasing from $236 million to $1.03 billion. The number of Medicare Part D enrollees using insulin doubled over these years, from 1.6 million to 3.3 million beneficiaries, which indicates that the increase in aggregate out-of-pocket spending was not solely a function of more Medicare beneficiaries using insulin.

The IRA is great news for the Medicare beneficiaries who make up nearly half of the population needing daily injections of insulin to live, but a provision in the original bill that would have capped the cost at $35 for all diabetics, not just those on Medicare, never made it to the final bill. Left out in the cold are the 3.7 million diabetics requiring insulin to keep living who are privately insured or not insured at all. That was an expense bridge too far for Republicans.

Will you permit a bit of cynicism here? Needing 60 votes to pass, 57 senators voted in favor of capping insulin at $35 per vial for all diabetics, 50 Democrats, seven Republicans.  Americans overwhelmingly support this as is shown in this Kaiser Family Foundation poll taken recently:

Eighty-nine percent consider this a priority, 53% a top priority. I suggest Republican leadership, never intending to allow this to pass, permitted those seven, standing for reelection this fall, to vote for the bill to give them cover in the upcoming election. Is that too cynical?

If that’s not bad enough, a study by Yale University researchers, published in Health Affairs, also in July, concluded that “Among Americans who use insulin, 14.1 percent reached catastrophic spending over the course of one year, representing almost 1.2 million people.” The researchers defined “catastrophic spending” as spending more than 40 percent of postsubsistence family income on insulin alone. Postsubsistence income is what’s left over after the cost of housing and food.

Nearly two-thirds of patients who experience catastrophic spending on insulin, about 792 thousand people, are Medicare beneficiaries. The IRA will help these people immensely. However, as it stands now it will do nothing to assist the non-Medicare diabetics who annually face catastrophic spending due to the cost of insulin. This group numbers about 408 thousand who need insulin just to go on living, and, yes, these are poor people with few resources.

Not to put too fine a point on it, but we should not forget that insulin isn’t the only medical resource diabetics use and need. There are also the syringes used to inject the stuff, not to mention the testing strips and glucose monitors that analyze the levels of blood glucose, which diabetics have to track religiously. Diabetes is an expensive disease, and insulin is only one part of the expense.

Every time I and others write about the cost and quality of health care in the US, it almost seems as if we’re all standing on the shore throwing strawberries at a battleship expecting some sort of damage. The Inflation Reduction Act contains the first significant health care move forward since the Affordable Care Act of 12 years ago. It’s progress at last, but so much more is needed.

A great historian and better American is now history himself

David McCullough has died. We have lost a giant.

McCullough had that special gift of telling stories of our past in ways that made us think we were there when they happened. He put us solidly in the shoes of the people he was writing about. For him, history is not about a was; it is about the is of the time. Like us, his subjects lived in a present, not a past. He never judged the choices made in the past; he just told the truth through stories meticulously researched and empathically written. That’s how he could win two Pulitzer Prizes, two National Book Awards and a Presidential Medal of Freedom.

I first met McCullough in the 1980s through his first book, The Johnstown Flood, published in 1968. I could not put it down. Read it through in one sitting. It was the start of his brilliant career, and its success gave him  hope he could actually devote himself to history and do well at it. But he never wrote for the money. What drove him was his love for and curiosity about understanding from whence we came.

In a 2018 interview for Boston Magazine with Thomas Stackpole, he was discussing his latest, and last, historical work, The Pioneers, about a group of New Englanders in the 19th century who picked themselves up, headed west,  settled Ohio, and courageously kept it an anti-slavery state. During the interview, he said:

There are an infinite number of benefits to history. It isn’t just that we learn about what happened and it isn’t just about politics and war. History is human. It’s about people. They have their problems and the shadow sides of their lives, just as we do, and they made mistakes, as we do. But they also have a different outlook that we need to understand. One of the most important qualities that history generates is empathy—to have the capacity to put yourself in the other person’s place, to put yourself, for example, in the place of these people who accomplished what they did despite sudden setbacks, deaths, blizzards, floods, earthquakes, epidemic disease. The second important thing is gratitude. Every day, we’re all enjoying freedoms and aspects of life that we never would have had if it weren’t for those who figure importantly in history.

Today’s Americans seem to think history begins about ten years ago. It is a modern day tragedy, and we own it.  Consequently, humanity keeps making the same mistakes over and over again, never learning from those who showed us where the land mines were lying, hidden underfoot. McCullough did that for 50 years. He leaves a large hole in our American universe.

Fudging data with style

Heading back to diabetes for a moment. You may recall the old adage, “Figures lie, and liars figure.” Well, this is not about that. The fudging I’m going to show has not a lie in it. What it does have is deception on a grand scale, and it comes from our CDC, which, usually, I greatly admire. But not this time.

As we’ve all learned throughout the COVID pandemic, the CDC tracks and reports data — a lot of it.

One of the things the CDC  reports about is Diabetes Mortality By State. It’s been doing it since 2005, and it’s in the last six years that we see, if we look, deception.

Here is how the CDC reported this data in 2015:

The redder things are, the worse they are, so this looks bad, and it is.  The scale above shows the distribution of the colors for the states, starting at 13.4 in Colorado and Nevada and ending at 32.4 in West Virginia. Those are deaths per 100,000 people.

Now, here is how the CDC reported diabetic mortality six years later in 2020:

In 2015 there were three dark red states, eight almost dark red states, and 20 almost almost dark red. But now we have only two dark red, three almost dark red, and those 20 semi dark states have turned to light tan. Wow! What an improvement.

One could be forgiven for going away happy….if one did not look at the actual numbers.

In 2015, Mississippi and West Virginia were the highest mortality states, 32.4 and 31.7 deaths per 100,000 people, respectively. Their numbers in 2020 soared about 30% to 41.0 and 43.1. The states with the lowest mortality in 2015, Nevada and Colorado (13.4 and 15.9), in 2020 are 18.0 and 24.2 deaths per 100,000. Wyoming now comes in with the second lowest mortality at 20.7.

But things look so much better. The distribution scale is different, but who looks at that?

The CDC has done something shameful; it has moved the goalposts and didn’t tell anyone. In reality, diabetic mortality has gotten much worse over the last six years, but unless you dug deep, not only would you not know that, you’d think there was an actual big improvement.

This is another reason why the insulin provision in the Inflation Reduction Act is a big deal.

 

 

What Price Life?

Thursday, November 29th, 2018

Part One

“Insulin is my gift to mankind” – Frederick Banting

A Quick Quiz

Question 1: Name a chronic disease requiring medication, which, if not taken every day, guarantees death within two weeks.
Answer: Type 1 Diabetes.

Question 2: Name the medication.
Answer: Insulin.

Question 3: What is the monthly cost of insulin for a Type 1 diabetic?
Answer: As we shall see, that depends.

Question 4: If Type 1 diabetics cannot afford the cost of insulin, without which they will surely die, what should they do?
Answer: This is happening at this moment, and people are dying.  In these two blog posts we’ll examine why and what can be done about it. But we need to first posit some truths about diabetes, and then describe how, in 1922, Canadian doctor Frederick Banting made the ground-breaking discovery that allowed Type 1 diabetics, for the first time in history, to live.

Ten Fast Facts

  1. Insulin is a hormone made by the pancreas that allows the body to use sugar (glucose) from carbohydrates in the food we eat for energy or to store glucose for future use. Insulin helps keeps blood sugar levels from getting too high (hyperglycemia) or too low (hypoglycemia). Type 1 diabetics, T1Ds, can no longer produce insulin. They have none of it. Although older adults can also contract Type 1 diabetes, it usually strikes children and young adults. Without insulin, whether old or young, they die.
  2. There are about 1.3 million T1Ds in the U.S. They comprise one half of one percent of the population. Currently, there is no cure for any of them. Without insulin, they will die.
  3. There are about 29 million Type 2 diabetics. T2Ds still make some insulin. In most, lifestyle changes will improve their health, sometimes to the point where they will no longer require insulin or any other medical prescriptions. Some will become insulin-dependent, and without it, they face life-changing complications.
  4. Diabetic Retinopathy is the leading cause of blindness.
  5. Diabetes is the leading cause of non-traumatic amputation.
  6. Diabetes is a leading cause of heart attack and stroke.
  7. Diabetes is the leading cause of kidney failure.
  8. Complications from diabetes sometimes cause workplace injuries and often exacerbate the severity and length of recovery.
  9. In 2017, the nation’s total direct medical costs due to diabetes were $237 billion. Average medical expenses for diabetics were 2.3 times higher than for non-diabetics. The extent to which diabetes added to workers’ compensation medical costs is unknown.
  10. Based on information found on death certificates, diabetes was the 7th leading cause of death in the United States in 2015, with 79,535 death certificates listing it as the underlying cause of death, and 252,806 listing diabetes as an underlying or contributing cause of death. However, diabetes is underreported as a cause of death; studies have found that only about 35% to 40% of people with diabetes who died had diabetes listed anywhere on the death certificate and only 10% to 15% had it listed as the underlying cause of death. An example of best practice would be, “Death caused by infection contracted from hemodialysis due to kidney failure, a complication of the patient’s diabetes.”

Banting and Insulin

Image result for photo of frederick banting

Frederick Banting is perhaps Canada’s greatest hero. Born in 1891, he graduated medical school with a surgical degree in 1915 and found himself in a French trench by the end of 1917. In December of that year, he was wounded during the Battle of Cambrai, the first great tank battle in history. He remained on the battlefield for 16 hours tending to other wounded soldiers until he had to be ordered to the rear to have his own wounds treated. For this action he won the British Military Cross, akin to America’s Silver Star. After returning to Canada, he continued his studies and, in 1920, secured a part time teaching post at Western Ontario University. While there, he began studying insulin Why? Serendipity. Someone had asked him to give a talk on the workings of the pancreas.

Banting became interested – and then obsessed – with trying to come up with a way to get insulin to people who couldn’t make any of their own. In November 1921, he hit on the idea of extracting insulin from fetal pancreases of cows and pigs. He discussed the approach with J. R. R. MacLeod, Professor of Physiology at the University of Toronto. MacLeod thought Banting’s idea was doomed to failure, but he allowed him to use his lab facilities while he was on a golfing holiday in Scotland. He also loaned him two assistants, Dr. Charles Best and biochemist James Collip. Collip devised a method to purify the insulin Banting and Best obtained from the fetal pancreases.

To MacLeod’s surprise, Banting’s procedure worked, and in 1922 Banting and Best successfully treated the daughter of US Secretary of State Charles Evans Hughes.

In 1923, one year later, Banting, at the age of 32, won the Nobel Prize, which, to his disgust, he had to share with MacLeod. To this day, Frederick Banting is the youngest person ever to win the Prize in Physiology or Medicine.

His discovery could have made Banting mind-numbingly rich, but he would have none of that. Along with Best and Collip, Banting patented his method and then the three of them sold the patent to the University of Toronto for the princely sum of $3.00. When asked why he didn’t cash in on his discovery, Banting said, “Insulin is my gift to mankind.” With Banting’s blessing, the University licensed insulin’s manufacturing to drug companies, royalty free. If drug companies didn’t have to pay royalties, Banting thought they would keep the price of insulin low.

And they did. For decades.

But patents expire, and capitalism being what it is, people get greedy, and greed is why we have no generic, low-cost insulin today and why, over the past 20 years, insulin prices have risen anywhere from 800% to 1,157%, depending on the variety and brand. It’s why, lacking health insurance, some Type 1 diabetics have recently been driven to ration their precious insulin. Some of them have died.

More about all that in Part Two.