Shortages in the Supply Chain affecting Insulin

FILE PHOTO: Insulin supplies are pictured in the Manhattan borough of New York City, New York, U.S., January 18, 2019. REUTERS/Carlo Allegri

Rev 6:6 NAS “And I heard something like a voice in the center of the four living creatures saying, “A quart of wheat for a denarius, and three quarts of barley for a denarius; and do not damage the oil and the wine.”

Important Takeaways:

  • Insulin shortage might be next supply chain crisis
  • According to the Centers for Disease Control and Prevention there are 37.3 million people with diabetes in the U.S. which is 11 percent of the U.S. population. An additional 96 million over the age of 18 have prediabetes. 7.4 million Americans with diabetes use one or more formulations of insulin and this number is growing. Unfortunately, the insulin supply is not. Just the opposite, in fact.
  • The FDA announced just before the pandemic started, in February, 2020, that there was going to be a drug shortage including insulin due to the initial COVID outbreak in China. Insulin prices have skyrocketed 600 percent in the past 20 years, and at least three states, California, Washington, and Maine, have been passing legislation with the intention of producing their own insulin
  • The insulin supply chain involves the delivery of insulin to patients and the flow of payments back. There are multiple middlemen that clog up the chain, and the monopolies of the three major companies involved, Novo Nordisk, Sanofi, and Eli Lilly, is part of the problem, as it is with baby formula.
  • The solution is multi-faceted and it includes more generics, biosimilars, public production, federal reserve, management algorithms and slow replacement of insulin with newer drugs which both help control diabetes and also decrease hunger and weight, a handy “two-for” which decreases insulin requirements

Read the original article by clicking here.

Why COVID-19 is killing U.S. diabetes patients at alarming rates

By Chad Terhune, Deborah J. Nelson and Robin Respaut

(Reuters) – Devon Brumfield could hear her father gasping for breath on the phone.

Darrell Cager Sr., 64, had diabetes. So his youngest daughter urged him to seek care. The next day, he collapsed and died in his New Orleans home.

The daughter soon learned the cause: acute respiratory distress from COVID-19. His death certificate noted diabetes as an underlying condition. Brumfield, who lives in Texas and also has type 2 diabetes, is “terrified” she could be next.

“I’m thinking, Lord, this could happen to me,” she said of her father’s death in late March.

She has good reason to fear. As U.S. outbreaks surge, a new government study shows that nearly 40% of people who have died with COVID-19 had diabetes.

Among deaths of those under 65, half had the chronic condition. The U.S. Centers for Disease Control and Prevention analyzed more than 10,000 deaths in 15 states and New York City from February to May.

Jonathan Wortham, a CDC epidemiologist who led the study, called the findings “extremely striking,” with serious implications for those with diabetes and their loved ones.

A separate Reuters survey of states found a similarly high rate of diabetes among people dying from COVID-19 in 12 states and the District of Columbia.

Ten states, including California, Arizona and Michigan, said they weren’t yet reporting diabetes and other underlying conditions, and the rest did not respond – rendering an incomplete picture for policymakers and clinicians struggling to protect those most at-risk.

America’s mortality rates from diabetes have been climbing since 2009 and exceed most other industrialized nations. Blacks and Latinos suffer from diabetes at higher rates than whites and have disproportionately suffered from COVID-19.

“Diabetes was already a slow-moving pandemic. Now COVID-19 has crashed through like a fast-moving wave,” said Elbert Huang, a professor of medicine and director of the University of Chicago’s Center for Chronic Disease Research and Policy.

Keeping diabetes under control – among the best defenses against COVID-19 – has become difficult as the pandemic disrupts medical care, exercise and healthy eating routines.

The high price of insulin has also forced some people to keep working – risking virus exposure – to afford the essential medicine. And as the country grapples with an economic crisis, millions of Americans have lost their jobs and their employer-sponsored health insurance.

Much of this could have been anticipated and addressed with a more comprehensive, national response, said A. Enrique Caballero, a Harvard Medical School endocrinologist and diabetes researcher.

Top health officials should have done more to emphasize the threat to people with diabetes and assuage their fears of hospital visits, he said, while also focusing more on helping patients manage their condition at home.

Policymakers had ample warning that COVID-19 posed a high risk for diabetes patients. In 2003, during the coronavirus outbreak known as SARS, or Severe Acute Respiratory Syndrome, more than 20% of people who died had diabetes.

In 2009, during the H1N1 flu pandemic, patients with diabetes faced triple the risk of hospitalization.

Most recently in 2012, when the coronavirus Middle East Respiratory Syndrome, or MERS, emerged, one study found 60% of patients who entered intensive care or died had diabetes.

The COVID-19 pandemic, however, has unearthed previously unknown complications because it has lasted longer and infected many more people than earlier coronavirus epidemics, said Charles S. Dela Cruz, a Yale University physician-scientist and Director of the Center of Pulmonary Infection Research and Treatment.

Doctors warn that the coronavirus pandemic may indirectly lead to a spike in diabetes-related complications – more emergency-room visits, amputations, vision loss, kidney disease and dialysis.

“My fear is we will see a tsunami of problems once this is over,” said Andrew Boulton, president of the International Diabetes Federation and a medical professor at the University of Manchester in England.

‘ONE BIG PUZZLE’

Researchers have scrambled for months to unravel the connections between diabetes and the coronavirus, uncovering an array of vulnerabilities.

The virus targets the heart, lung and kidneys, organs already weakened in many diabetes patients. COVID-19 also kills more people who are elderly, obese or have high blood pressure, many of whom also have diabetes, studies show.

On the microscopic level, high glucose and lipid counts in diabetes patients can trigger a “cytokine storm,” when the immune system overreacts, attacking the body. Damaged endothelial cells, which provide a protective lining in blood vessels, can lead to inflammation as white blood cells rush to attack the virus and may cause lethal clots to form, emerging research suggests.

“It’s all one big puzzle,” said Yale’s Dela Cruz. “It’s all interrelated.”

Many of their vulnerabilities can be traced to high blood sugar, which can weaken the immune system or damage vital organs. COVID-19 appears not only to thrive in a high-sugar environment but to exacerbate it. Recent evidence suggests the virus may trigger new cases of diabetes.

David Thrasher, a pulmonologist in Montgomery, Alabama, said up to half of COVID-19 patients in his local hospital ICU have diabetes. “They are often my most challenging patients,” he said, and the immune system response may be a big reason why.

‘DIABETES BELT’

The pandemic has ripped through several southern states with some of the nation’s highest diabetes rates. A Reuters examination of state data found that nearly 40% of COVID-19 deaths were people with diabetes in Alabama, Louisiana, Mississippi, North Carolina, South Carolina and West Virginia. Much of this area lies within what the CDC calls the “diabetes belt.”

Alabama has the highest percentage of adults with diabetes at 13.2%, or more than 550,000 people, CDC data show. Diabetes patients accounted for 38% of the state’s COVID-related deaths through June, officials said. Karen Landers, Alabama’s assistant state health officer, said she is particularly heartbroken at the deaths of diabetes patients in their 30s and 40s.

Medical professionals in these states say they struggle to keep patients’ diabetes under control when regular in-person appointments are canceled or limited because of the pandemic.

Sarah Hunter Frazer, a nurse practitioner at the Medical Outreach Ministries clinic for low-income residents in Montgomery, Alabama, said diabetes is common among her COVID-19 patients. With clinic visits on hold, she stays in touch by phone or video chat. If a problem persists, she insists on an outdoors, face-to-face meeting. “We meet them under a shade tree behind the clinic,” Frazer said.

In similar fashion, doctors at the University of North Carolina stepped up their use of telemedicine to reach at-risk rural patients. Despite those efforts, John Buse, a physician and director of the university’s diabetes center, said he’s certain some foot ulcers and dangerously high blood sugars are being missed because people avoid health facilities for fear of the virus.

‘UNDER CONTROL’

Many diabetes patients with severe or deadly cases of COVID-19 were in good health before contracting the virus.

Clark Osojnicki, 56, of Stillwater, Minnesota, had heard early warnings about the risks of the coronavirus for people with diabetes, said his wife, Kris Osojnicki. But the couple didn’t think the admonitions applied to him because his glucose levels were in a healthy range.

“He was incredibly active,” she said.

On a Sunday in mid-March, Osojnicki jogged alongside his border collie, Sonic, on an agility course for dogs inside a suburban Minneapolis gym. Three days later, Osojnicki developed a fever, then body aches, a cough and shortness of breath. He was soon in the hospital, on a ventilator. Clark, a financial systems analyst, died April 6 from a blood clot in the lungs.

Osojnicki is among 255 recorded deaths in Minnesota of people with COVID-19 and diabetes mentioned on their death certificate as of mid-July, according to state data. The records describe people who died as young as 34.

WORKING FOR INSULIN

For years, the skyrocketing cost of insulin has fueled much of the national outrage over drug prices. Early in the pandemic, the American Diabetes Association asked states to eliminate out-of-pocket costs for insulin and other glucose-lowering medications through state-regulated insurance plans.

But no state has fully followed that advice, the ADA said. Vermont suspended deductibles for preventive medications, like insulin, starting in July. Other states ordered insurers to make prescription refills more available but didn’t address cost.

Robert Washington, 68, knew his diabetes put him at risk from COVID-19. When his employer, Gila River’s Lone Butte Casino in Chandler, Arizona, reopened in May, he decided to keep working as a security guard so he could afford insulin.

Washington’s supervisors had assured him he could patrol alone in a golf cart, said his daughter, Lina. But once back at work, he was stationed at the entrance, where long lines of gamblers waited, most without masks, Robert told his daughter.

“He was terrified at what he saw,” Lina said.

He tested positive for the virus in late May and was admitted to the hospital days later. He died from complications of COVID-19 on June 11, his daughter said.

A week after Washington’s death, the casino again closed as COVID-19 cases exploded in the state. The casino did not respond to a request for comment.

“It’s hard to accept he is gone. I have to stop myself from wanting to call him,” said Lina, a sports anchor and reporter at a Sacramento, California, TV station. “A lot of these deaths were in some way preventable.”

(Reporting by Chad Terhune, Deborah J. Nelson and Robin Respaut; Editing by Brian Thevenot)

American caravan arrives in Canadian ‘birthplace of insulin’ for cheaper medicine

Type 1 diabetes advocates from the United States depart a Canadian pharmacy after purchasing lower cost insulin in London, Ontario, Canada June 29, 2019. REUTERS/Carlos Osor

By Tyler Choi

TORONTO (Reuters) – A self-declared “caravan” of Americans bused across the Canada-U.S. border on Saturday, seeking affordable prices for insulin and raising awareness of “the insulin price crisis” in the United States.

The group called Caravan to Canada started the journey from Minneapolis, Minnesota on Friday, and stopped at London, Ontario on Saturday, to purchase life-saving type 1 diabetes medication at a pharmacy.

The caravan numbers at approximately 20 people, according to Nicole Smith-Holt, a member of the group. Smith-Holt said her 26-year-old son died in June 2017 because he was forced to ration insulin due to the high cost. This is Smith-Holt’s second time on the caravan.

Caravan to Canada trekked the border in May for the same reasons, which Holt-Smith said was smaller than the group this week. She said Americans have gone to countries like Mexico and Canada for more affordable medications in the past and continue to do so.

The Canadian Broadcasting Corporation reported in May that Canadian pharmacists have seen a “quiet resurgence” in Americans coming to Canada looking for cheaper pharmaceuticals.

Insulin prices in the United States nearly doubled to an average annual cost of $5,705 in 2016 from $2,864 in 2012, according to a study in January.

Allison Nimlos, a Type 1 diabetes advocate from the United States, shows the less expensive Canadian insulin she purchased (right) after leaving a Canadian pharmacy in London, Ontario, Canada June 29, 2019. REUTERS/Carlos Osorio

Allison Nimlos, a Type 1 diabetes advocate from the United States, shows the less expensive Canadian insulin she purchased (right) after leaving a Canadian pharmacy in London, Ontario, Canada June 29, 2019. REUTERS/Carlos Osorio

While not everyone purchased the same amount of insulin, Smith-Holt said most people are saving around $3,000 for three months of insulin, and as a whole, the group is saving around $15,000 to $20,000.

Prescriptions for insulin are not required in Canadian pharmacies Smith-Holt said, but the caravan has them so they can prove to the border patrol they are not intending to resell them when returning to the United States.

Quinn Nystrom, a leader of T1International’s Minnesota chapter, said on May via Twitter that the price of insulin in the United States per vial was $320, while in Canada the same medication under a different name was $30.

T1International, a non-profit that advocates for increased access to type 1 diabetes medication, has described the situation in U.S. as an insulin crisis.

“We know that many people couldn’t make this trip because they cannot afford the costs associated with traveling to another country to buy insulin there,” said Elizabeth Pfiester, the executive director of T1International in a press release.

An itinerary states the caravan will stop at the Banting House in London, Ontario later in the day. The Banting House is where Canadian physician and scientist Frederick Banting, who discovered insulin, lived from 1920 to 1921, and is called the “birthplace of insulin”, according to the Banting House website.

Smith-Holt said the group is not currently planning any future trips, but they could be organized in the near future depending on need. She hopes for long-term solutions in the United States like price caps, anti-gouging laws, patent reform and transparency from pharmaceutical companies.

(Reporting by Tyler Choi, Editing by Franklin Paul)

Eli Lilly backs U.S. proposal on drug rebates to lower costs

The logo and ticker for Eli Lilly and Co. are displayed on a screen on the floor of the New York Stock Exchange (NYSE) in New York, U.S., May 18, 2018. REUTERS/Brendan McDermid

By Tamara Mathias

(Reuters) – Eli Lilly and Co on Wednesday embraced a U.S. government proposal to end a decades-old system of rebates drugmakers make to industry middlemen, saying it could lower the cost of insulin and other prescription drugs for patients.

Lilly, along with other major insulin makers, Sanofi SA and Novo Nordisk, has been under mounting pressure from patients and politicians over the rising cost of the life-sustaining diabetes treatment.

“While it’s still a proposal, we see this as … a win for patients, lowering their out-of-pocket costs at the pharmacy counter with the greatest benefit realized by patients taking more highly-rebated products such as insulin,” Chief Executive David Ricks said on a call with analysts.

Drugmakers argue they have to keep prices high because of the rebates they must pay to pharmacy benefit managers and health insurers to get products on their lists of covered drugs. In January, the administration of U.S. President Donald Trump proposed a rule that would end the rebate system or pass along the savings to patients.

“We’ll adapt to whatever rules come out and how they get finalized,” Ricks said.

Lilly on Wednesday also cut its 2019 profit and revenue forecasts to account for disappearing sales of its cancer drug Lartruvo, which won conditional U.S. approval in 2016 based on early data but last month failed to extend patient survival a confirmatory trial. Costs related to Lilly’s pending $8 billion acquisition of Loxo Oncology also contributed to the revised forecast.

Lilly has said it is suspending promotion of Lartruvo and it will no longer be prescribed to new U.S. patients.

The Indianapolis-based drugmaker’s research and development spending is also expected to rise as it develops Loxo’s pipeline of targeted drugs for cancers driven by rare genetic mutations.

The company said it now expects 2019 adjusted earnings of $5.55 to $5.65 per share, down from its prior forecast of $5.90 to $6.00. It expects revenue of $25.1 billion to $25.6 billion versus its prior view of $25.3 billion to $25.8 billion.

“The forecast cut was generally expected, given the Loxo acquisition and the Lartruvo failure were known events,” Edward Jones analyst Ashtyn Evans said.

“Diabetes will always be an area where we’ll see pricing pressure. Lilly fully takes that into consideration when giving guidance,” she added.

Excluding items, Lilly earned $1.33 per share, a penny shy of analysts’ average estimate, according to IBES data from Refinitiv.

Eli Lilly shares fell 1.3 percent to $118.82.

(Reporting by Manogna Maddipatla, Tamara Mathias in Bengaluru and Julie Steenhuysen in Chicago; Editing by Saumyadeb Chakrabarty and Bill Berkrot)

New diabetes treatment could be ‘game-changer’

A new form of treatment for Type 1 Diabetes that uses a patient’s own cells to fight the disease is being hailed as a potential “game-changer” after an early trial suggests that it’s safe for patients.

A research team headed by University of California San Francisco scientists recently put the treatment through its first U.S. safety trial and said patients reported no serious side effects.

That’s cleared the way for more tests, but there’s a way to go before the method is mainstream. Researchers still need to determine how effective the new form of treatment is against Type 1 Diabetes, an immune disease in which human bodies attack the cells that produce insulin.

While many traditional treatment methods go after the immune system, the researchers wrote in a news release that may increase the odds of a person developing an infection or even cancer.

The method being studied involves removing less than two cups of blood from a patient’s body to find certain kinds of cells called regulatory T cells, or Tregs. Scientists sort the Tregs and place them in a growth medium to boost their numbers, then inject them back into the patient’s body.

The goal is for those enriched Tregs to help bodies battle the attacks on insulin-producing cells while still keeping their immune systems fit enough to hold off other diseases and infections.’

The researchers said in the news release that all the signs to date have been encouraging, and that all of the 14 patients tolerated the Treg treatment well. The next step is a Phase 2 trial, another step toward confirming the treatment is actually beneficial for patients with the disease.

“This could be a game-changer,” UC San Francisco researcher Jeffrey A. Bluestone said in the news release. “For type 1 diabetes, we’ve traditionally given immunosuppressive drugs, but this trial gives us a new way forward. By using Tregs to ‘re-educate’ the immune system, we may be able to really change the course of this disease.”

About 1.25 million Americans have Type 1 Diabetes, the American Diabetes Association says.