CENTER CITY, Minnesota (Reuters) – Ron Carlson, allegra d bula xarope like many Americans with diabetes, got the message trumpeted in drugmakers’ unrelenting ads and reinforced by doctors: Use medications to lower your blood sugar to a specific target, and you can live a longer, healthier life.
He took that message to heart, and it killed him.
One evening in July 2019, the retired software engineer arrived at Al’s Center Saloon in this lakeside town for his weekly dinner with friends. Just as Carlson was guiding his Honda motorcycle into a parking spot, the bartender at Al’s looked out the window to see him stagger and then squeeze the bike’s throttle as he tried to steady himself. The engine roared, the tires squealed, and Carlson sped 30 yards across the lot, slamming into a parked car.
Carlson tumbled to the pavement. Blood pooled on the asphalt. Volunteer firefighters and then an ambulance crew tried to revive him, but he was later pronounced dead at a local hospital. He was 66 years old.
The medical examiner attributed Carlson’s death to chest trauma and hypoglycemia, or extremely low blood sugar. Hypoglycemia is a medical emergency characterized by confusion, dizziness and loss of coordination. Untreated, it can quickly lead to coma and death. And it’s almost always a side effect of diabetes treatment.
Carlson’s wife, Lucy, had feared something like this would happen. Ron was diagnosed with type 2 diabetes in 2001, and Lucy said he was obsessed with lowering his A1c score, a measure of average blood sugar over three months, to below 7%. That’s the goal that drugmakers, public health officials and medical professionals have promoted for years. To reach it, Carlson kept close tabs on his blood sugar to calibrate multiple insulin injections daily and took another glucose-lowering drug.
Carlson’s scrupulous drug regimen had brought his A1c score down to 7.5%, but at an alarming cost. Carlson suffered multiple episodes of hypoglycemia before his death. He hit a car in a mall parking lot after his blood glucose plunged. Another time, he fainted at home and cut his face on broken glass. He was hospitalized in 2017 after a bout of hypoglycemia left him unable to speak or move one side of his body.
While trying to manage a disease defined by dangerously high blood sugar, Carlson ended up dying of the opposite. His widow blames his single-minded focus on A1c. “He really tried hard to be at 7,” Lucy Carlson said. “That is what actually killed him.”
DIRE CONSEQUENCES
Carlson was a casualty of an epidemic of hypoglycemia among Americans with diabetes that has resulted in millions of medical emergencies and thousands of deaths. This epidemic, a Reuters investigation has found, was fueled by a drug industry campaign that began two decades ago to promote an aggressive diabetes treatment goal – the A1c below 7% that Carlson strived to reach.
As Reuters reported earlier this year, the COVID-19 pandemic exposed a more deeply rooted U.S. public health crisis as a disproportionate number of people with diabetes died. Years of inadequate treatment of their chronic disease had left them particularly vulnerable to the virus and the isolation of lockdown. But while many diabetes patients struggle to obtain sufficient care, many others, it turns out, are chasing a treatment goal that could kill them.
Interviews with dozens of scientists, doctors and patients and a review of hundreds of documents found that leading insulin makers began to promote A1c below 7% just as they were launching new formulations of insulin and other diabetes drugs that they then heavily marketed as a way for patients to reach that target.
Leading the charge was Aventis SA of France, and then Sanofi SA after it acquired Aventis in 2004. Aventis donated heavily to the American Diabetes Association (ADA) and other key groups that supported A1c below 7% for most patients. It launched a multimillion-dollar ad campaign and got elected officials, community centers and hospitals to spread the word. Fellow insulin makers Novo Nordisk A/S and Eli Lilly & Co were also big ADA donors, and soon, they and other companies were boasting of their drugs’ A1c-lowering abilities.
The drugmakers scored a resounding success: As doctors bumped up medications to meet the new treatment goal among an ever growing number of people with diabetes, U.S. sales of diabetes drugs soared, to $74 billion last year from $7.3 billion two decades earlier, according to the IQVIA Institute for Human Data Science. The figures exclude discounts and rebates that drugmakers give to health plans. By 2017, annual spending on insulin and other glucose-lowering drugs had jumped 147% from a decade earlier to $2,727 per patient, government data show.
Those increases reflect more prescriptions, and also higher prices. For years, diabetes was treated largely with generic drugs and conventional insulins. Then drugmakers launched a slew of more expensive patented drugs and promoted many of them as a way to reach an A1c below 7%. More than 50 new diabetes medications hit the market in the past two decades, comprising new formulations of insulin, as well as other injections and pills.
To underpin its campaign, the industry cited research showing that achieving an A1c below 7% reduced the risk of the potentially deadly long-term complications of diabetes. Lost in the enthusiasm were warnings about adopting aggressive drug regimens to do that. The medications people with diabetes must take to lower their high blood glucose carry the risk of going too far, tipping a patient into hypoglycemic crisis. Ratcheting up doses would increase that danger, especially for older people, who are already at greater risk due to their age and condition.
EMERGENCY CALLS
The warnings were prescient. For much of the 1990s, hospitalization rates among the elderly for hyperglycemia, high blood sugar resulting from uncontrolled diabetes, and hypoglycemia, primarily a side effect of treatment, were similar. Then, as drugmakers began promoting A1c below 7%, hospitalization rates for hypoglycemia climbed, soaring to five times the rate for hyperglycemia in the next decade.
By 2016, the last year for which government data are available, hospitalization rates had subsided as increasing awareness of the problem prompted fine-tuning of treatment guidelines. Still, as the pharmaceutical industry has continued to emphasize a lower A1c, hypoglycemia remains an outsized risk.
From 2017 to 2020, emergency services received at least 923,000 calls related to hypoglycemia, Reuters found in an analysis of the National Emergency Medical Services Information System, a database of 911 emergencies from 47 states. Those emergencies accounted for 58% of all diabetes-related incidents during the period, while hyperglycemia accounted for 41%. Among people 65 and older, hypoglycemia made up two-thirds of diabetic emergencies.
In at least 532 of those calls, the patient died before or during the emergency response. More broadly, U.S. deaths related to hypoglycemia reached nearly 3,000 in 2019 – most of them elderly patients – data from the U.S. Centers for Disease Control and Prevention (CDC) show.
Deaths from hypoglycemia are probably undercounted, experts said. The confusion and loss of coordination that low blood sugar causes can lead to falls, traffic accidents and other lethal incidents that mask the underlying condition. Police sometimes mistakenly assume a hypoglycemic patient is intoxicated, which can delay critical treatment.
‘NOT FOR EVERYONE’
In recent years, the ADA has refined its guidance, retaining the overall target of A1c below 7%, but adding exceptions and warnings for the elderly and others who have borne an outsized impact of overtreatment.
Drugmakers say the A1c target of below 7% is supported by sound science and has benefited millions of people.
A Sanofi spokesperson said the company promoted that target based on scientific knowledge at the time. The guidelines have since changed, based on new data over the last 20 years, to “a more individualized approach,” she said.
She added that Sanofi’s work with outside organizations has been critical in “helping generate awareness among patients and (healthcare providers) of the latest scientific evidence that has been proven to improve patient care.”
Novo Nordisk said that its medicines “help people with diabetes reach their individualized treatment targets identified by their healthcare professional.”
Eli Lilly said it has helped doctors and patients “make informed decisions about treatment options” and “there is no one-size-fits-all target for A1c.”
Dr Richard Kahn, the ADA’s chief scientific and medical officer from 1985 to 2009, said, “From the get-go the ADA clearly and explicitly … said (the A1c target of below 7%) is not for everyone. It has to be individualized.”
But even one of the scientists whose research laid the foundation for the A1c below 7% target told Reuters that the industry’s marketing message has overwhelmed the crucial point that treatment goals should reflect a patient’s risk for hypoglycemia. “Marketing that everyone in the world needs to have an A1c less than 7% is crazy,” said Dr David Nathan, a Harvard Medical School professor. “We need to do this wisely. And somehow that got lost.”
The marketing drumbeat persists. Last year, drugmakers spent more than $650 million on diabetes-related advertising, second only to dermatology among disease categories, market research firm Kantar found. And so far this year, seven of the top 10 diabetes TV commercials in terms of dollars spent promote the drug’s ability to lower A1c to less than 7%, according to a Reuters review of ads compiled by research firm iSpot.tv.
During broadcasts of this year’s Summer Olympics, American gymnast Laurie Hernandez praised the benefits of Eli Lilly’s Trulicity for type 2 patients like her father. With weekly glucose-lowering injections, “most people reached an A1c under 7%,” the commercial said. Current ads for Novo Nordisk’s Ozempic also tout that drug’s ability to lower A1c to less than 7%.
“Pharmaceutical companies keep encouraging tight control, which requires increased use of their medications,” said Dr Sei Lee, a geriatrician and professor of medicine at the University of California at San Francisco who has studied diabetes in older adults. “It is important to recognize the absolute magnitude of the hypoglycemia epidemic. It’s become far too common.”
AN INTIMATION OF MORTALITY
The intense focus on A1c and using drugs to lower it is a largely American phenomenon, researchers say. One reason: It’s easier to spread the message in direct-to-consumer advertising of prescription drugs, which is legal only in the United States and New Zealand.
There is no question that glucose control is essential to the long-term health of people with diabetes. Over time, persistently high blood glucose damages the circulatory system, often leading to severe complications: heart attack, stroke, kidney disease, amputations, and blindness.
The 1.6 million people in the United States with type 1 diabetes, who produce little or no insulin, must inject the hormone to keep their blood glucose in a tight range. Far more Americans – 32 million and counting – have type 2 diabetes, an inability to make enough insulin or to use it well. They may be able to control their condition with diet and exercise, but many end up using insulin and other drugs.
The problem is that many of the people using their medication to lower their A1c to below 7% are those most at risk from doing so – the elderly. Diabetes affects 1 in 5 seniors. Spending on insulin alone by the taxpayer-funded Medicare insurance program for the elderly surged to $14.3 billion in 2018, before rebates, from $3 billion eight years earlier.
As people age, their liver and kidneys don’t function as well, so insulin stays in the body longer and can increase the risk of low blood sugar. Older people also are less likely to recognize they are in a hypoglycemic crisis. Among people 65 and older, insulin accounted for 11% of emergency room visits from an adverse drug event, a three-year CDC study published last month found.
The CDC researchers said that while some of the newer diabetes drugs pose less risk of hypoglycemia, the many patients who rely on insulin require close monitoring to prevent emergencies.
Just one hypoglycemic episode is a red flag. One-third of older type 2 patients who experienced a severe case of low blood sugar died within three years, regardless of their underlying condition, a 2017 study by researchers at Johns Hopkins University found.
Doctors can reduce the medication of patients who have too many hypoglycemic episodes or who are at increased risk. But experts said many doctors, pressed for time or underestimating the dangers, too often don’t reassess their patients and adjust treatment as they age. “These everyday drugs pose a hidden danger to our parents and grandparents,” said Dr Elbert Huang, director of the University of Chicago’s Center for Chronic Disease Research and Policy.
AIMING LOW
The hemoglobin A1c test, developed in the 1970s, provides a snapshot of a patient’s average blood glucose over the previous three months. For clinicians, the simple blood test became an attractive tool to evaluate how well patients were managing their disease.
For drugmakers, the test provided a faster, cheaper way to assess a drug’s effectiveness. Until then, proving that a drug could reduce diabetic complications required tracking a large number of patients over many years. Merely showing that a drug lowered a lab result such as A1c took a fraction of the time and cost.
In 1993, scientists funded by the U.S. National Institutes of Health published the results of a 10-year study of type 1 patients who lowered their average blood glucose over time to an A1c of 7%. The treatment, the study concluded, reduced the risk of eye, nerve and kidney damage.
That fueled enthusiasm among researchers, regulators and the ADA for A1c as a key health measure. Many assumed that lowering A1c would yield similar benefits for the much larger population of type 2 patients. The ADA, whose treatment guidelines are considered the gold standard by patients and doctors, cited the study when it recommended in 1994 an A1c below 7% but advised doctors to take “action” only for patients above 8%. The U.S. Food and Drug Administration began approving diabetes drugs that were shown to improve A1c.
Then, in 1998, a 20-year study of type 2 patients in the United Kingdom found that maintaining an A1c of 7% lowered their risk of eye disease and other complications.
Both studies reported a significantly increased risk of hypoglycemic episodes in the tight-control groups. But these warning signs attracted little attention as the pharmaceutical industry revved up development of dozens of new drugs and launched an offensive to persuade more medical providers and patients to pursue an A1c below 7%.
Notable among these efforts was that of Aventis, maker of Lantus, a long-acting insulin approved by the FDA in 2000. Lantus became one of the best-selling medications ever worldwide, generating more than $70 billion in sales to date.
‘THE LIFE THAT GOD GAVE THEM’
On World Diabetes Day in November 2002, Aventis launched a multimillion-dollar promotional blitz under the trademarked title “Aim. Believe. Achieve: The Diabetes A1C Initiative.” The company hired public-relations powerhouse Burson-Marsteller, now known as BCW, and lined up the Congressional Diabetes Caucus to fan out across the nation, urging people to “hold those levels under 7 percent.”
Then-U.S. Health and Human Services Secretary Tommy Thompson called on all Americans to help people with diabetes “aim for, believe in, and achieve a target A1C of less than 7%.”
The same day, Aventis dispatched an army of influencers called “A1C Champions” to carry its message to the public. The champions were a diverse crew of diabetes patients, including an Army veteran from Maryland, a bookkeeper from Michigan, and a piano teacher from Chicago. They spoke in hospital cafeterias, YMCAs and community centers and at health fairs on behalf of Aventis, and then Sanofi after the companies’ 2004 merger.
The champions were motivated by a desire to help others, said Greg Pfaff, who hit the road after closing his Virginia deli. Now a real estate agent, Pfaff told Reuters he enjoyed teaching “people how to get good control, so they can live the life that God gave them.”
In 2004, 50 mayors from the U.S. Conference of Mayors filmed public-service announcements urging their constituents with diabetes to get their A1c below 7%. The previous year, Aventis joined the group’s Corporate Circle, which required annual dues of $12,000. The Conference of Mayors told Reuters the campaign was part of a one-year partnership with Aventis to help prevent diabetic complications.
But Aventis’s most powerful ally was the ADA, whose guidelines and support were cited in the company’s campaign to lend weight to the message. In 2004, the ADA added the A1c below 7% target to a program that publicly recognized doctors for getting diabetes patients to reach specific goals. That achievement can help doctors attract patients and secure a spot in insurer networks.
Aventis, Eli Lilly and Novo Nordisk were among the ADA’s top tier of donors at the time, giving at least $750,000 a year. Eli Lilly, Novo Nordisk and Sanofi have remained major ADA donors.
Kahn, the ADA’s chief scientific and medical officer at the time, said donations did not influence the organization’s actions. He said the ADA worked with drugmakers to promote A1c below 7% based on scientific evidence, citing “two major forces” behind that target: Dr Robert Rizza of the Mayo Clinic and Nathan, the Harvard Medical School professor, who were investigators in the 1993 study that helped launch the A1c below 7% movement.
Rizza was an ADA vice president in 2003 and 2004 and president in 2005. Nathan served as an expert adviser in a variety of roles.
At the time, Rizza was also working on a clinical trial, partially funded by Aventis, that found that the company’s Lantus insulin resulted in a “slightly but significantly lower” A1c than a competitor’s insulin among type 1 patients, though the study said both provided “excellent glycemic control.” In the study, published in 2005, Rizza also reported that Aventis paid him an unspecified amount in consulting fees.
Rizza told Reuters he did not recall receiving the payments. He said he donated all honoraria to the Mayo Clinic while executive dean of research there from 2005 to 2013, which a Mayo spokesperson confirmed. From 2013 to 2019, Novo Nordisk, Eli Lilly and other companies paid him more than $275,000 for consulting and covered $200,000 in travel, lodging and meals, government data show.
“My role always was to provide scientific advice,” Rizza said. “I therefore never have found myself in any conflict with my role as an advocate for people with diabetes and the pharmaceutical industry’s goal of developing new therapies.”
In the early 2000s, Nathan reported receiving research grants from Aventis in papers he co-authored on management of type 2 diabetes. More recently, Sanofi contributed drugs to a National Institutes of Health trial that he led, comparing drugs for glycemic control of type 2 diabetes. Nathan told Reuters that industry support did not influence him.
While the ADA’s initiative would encourage doctors to set an A1c below 7% target for their patients, it wouldn’t hold them accountable for achieving it. For that, the industry-ADA alliance set its sights on the Washington-based National Committee for Quality Assurance (NCQA). This nonprofit group develops performance measures for medical care and then bestows its seal of approval on health insurers and medical providers that meet those goals.
Nathan told Reuters that he argued against the move. He said that while research clearly showed that an A1c below 7% could benefit many patients, he feared that setting it as an NCQA performance measure would push doctors to prescribe glucose-lowering treatments “without any sense as to whether it was the right thing to do for the patient in front of them.”
CRUSHING THE OPPOSITION
To resolve such disagreements, the NCQA, ADA, CDC and 10 other public and private entities had already put together an expert panel to advise them on setting performance measures for diabetes care. In late 2004, Dr Nathaniel Clark, the ADA’s national vice president for clinical affairs, and representatives of two other organizations wrote to the panel, on letterhead with Aventis’s “A1c<7 by 2007” slogan, endorsing that as an NCQA performance standard.
The same year, Sanofi, having acquired Aventis, and Novo Nordisk contributed enough to the NCQA to earn “Platinum” status, meaning annual donations of $250,000 or more.
A Sanofi spokesperson said that the company’s payments “are in compliance with a strict set of rules – both by law and internal review” and that “these partnerships are critical in helping generate awareness … of the latest scientific evidence that has been proven to improve patient care.”
The expert panel, made up of 15 diabetes researchers from more than a dozen universities and health organizations, voted unanimously in 2005 against A1c below 7% as a performance measure. It said that such an aggressive target would promote “expensive polypharmacy,” or taking multiple medications daily, for only modest benefits. The panel instead recommended a performance measure focused on lowering the A1c of patients at highest risk of developing complications, those over 9%.
Kahn, spearheading the ADA’s campaign at the time, told Reuters that he disagreed with the panel. The benefits of lowering A1c below 7% “outweigh the possible negative consequences” for most people, he wrote in an email, even if “the trade-off in some patients would be an increased cost of care and/or an increased likelihood of untoward side effects,” including severe hypoglycemia.
Kahn fought back, taking aim at two groups of influential diabetes specialists who had also opposed the lower A1c target: the American Association of Clinical Endocrinologists (AACE) and the Endocrine Society. In an April 28, 2006, email to several dozen doctors, researchers, government officials and drug company employees, Kahn wrote that “in ADA’s struggle to improve care, one would never imagine that the opposition comes from within our very own discipline.” He urged the recipients to “join me by writing or calling their leaders.”
On May 9, the presidents of the two endocrinology groups had a conference call with the ADA to “resolve our differences,” according to an email sent to AACE members. The next day, the NCQA voted to adopt A1c under 7% for “good control” of diabetes.
Dr Greg Pawlson, an NCQA executive vice president at the time who worked on the measure, said the prevailing view was that undertreatment of diabetes was a major problem. “I think we made a reasonable and prudent effort to balance the two sides,” he said.
Thirteen members of the advisory panel who had rejected A1c below 7% wrote a letter urging the NCQA to reconsider its decision. Using that target as a performance measure could give doctors an incentive to “over-treat patients, potentially leading to unwarranted healthcare costs, patient burden and perhaps even patient safety problems,” panel members wrote.
The performance measure also encountered fierce opposition from doctors with the U.S. Department of Veterans Affairs (VA) health system. They treat many older patients suffering from multiple chronic conditions, and they believed the new performance standard would cause patients to “suffer needlessly and some would die,” said Dr David Aron, a professor at Case Western Reserve University and member of the VA/Defense Department diabetes clinical practice guidelines committee.
When the NCQA went ahead anyway, Aron said he and his colleagues argued against adopting the new measure at the VA. Instead, the health system chose to keep its own guidelines, which included individualized A1c targets based on a patient’s age and health.
Subsequent research supported the VA’s position that lower is not always better. In its June 2008 issue, the New England Journal of Medicine published reports from two large clinical studies that raised questions about the safety and benefits of intensive glucose control for type 2 patients.
One of them, the so-called ACCORD trial, sponsored by the National Institutes of Health, had sought to lower the A1c of older diabetes patients with or at risk of heart disease to nearly normal – below 6%. But it was halted when patients in the intensive-therapy group, after getting down to an average A1c of 6.4%, started dying at a higher rate than those who averaged 7.5% on standard therapy. Researchers reported no major benefits from more intensive treatment to offset the increased rate of death and other complications, including hypoglycemia.
The second study, called ADVANCE, found that lowering A1c to an average of 6.5% failed to reduce heart-related complications compared to 7.3% and heightened the risk of severe hypoglycemia.
ADJUSTING THE GOAL
In response to those studies, the NCQA in 2008 began to relax its performance measure for successful management of diabetes to an A1c below 7% for selected patients and below 8% overall.
Dr Mary Barton, vice president for performance measurement at NCQA since 2011, said she can’t speak to actions taken before her tenure. She expressed confidence in the group’s current A1c standard, which allows more leeway for older patients and those with multiple conditions.
“Any patient who is showing up in the emergency department with hypoglycemia, there’s something wrong,” Barton said. Many deaths “can be avoided” if doctors would adjust glucose control treatment as patients age, she said.
The ADA has tempered its guidelines from its original recommendation that the A1c goal for adults is below 7%.
In 2012, it said less than 8% may be appropriate for people with a history of severe hypoglycemia, advanced complications or other medical conditions. In 2018, it acknowledged that “overtreatment of diabetes is common in older adults and should be avoided.” The next year, it advised doctors to “reassess glycemic targets over time” in older adults. Today, the ADA says an A1c below 7% for many adults “without significant hypoglycemia is appropriate.”
In a statement to Reuters, the ADA’s current chief scientific and medical officer, Dr Robert Gabbay, said the organization promotes tools to manage the risk of hypoglycemia among some patients. The ADA did not address questions regarding the magnitude of hypoglycemic emergencies in the United States.
Clark, the ADA vice president for clinical affairs from 2001 to 2006, told Reuters that in retrospect the heavy emphasis on 7% was misguided, given the risks to many elderly patients. “It’s not as simple as we thought,” said Clark, now an endocrinologist in Massachusetts.
‘ARE YOU OK?’
Ron Carlson met Lucy Walch online in 2003, two years after his type 2 diabetes diagnosis. They dated for eight years, and married in 2011. As a software engineer, he had traveled the world handling installations for jet engine projects. She’s a registered nurse who has specialized in occupational health and safety.
Shortly after getting married, they moved from suburban Minneapolis-Saint Paul to a small farm in Lindstrom, Minnesota, with a vineyard and rows of white spruce and pine trees. Hypoglycemia soon became a recurring problem.
One weekend in 2012, Ron collapsed at the local golf course during a putting class with Lucy. Employees called 911, and he spent the night in the hospital.
Two years later, on the way to a hardware store, Ron picked up speed while driving downhill. “Are you OK?” Lucy blurted out.
He didn’t respond and kept driving. She got him to swallow some candy to raise his blood sugar, and in the store parking lot, she gave him glucose gel, which also helps reverse hypoglycemia. Within 10 minutes, he was better.
For years, Ron’s doctors advised him to strive for an A1c below 7%, according to Lucy. In April 2017, he was prescribed an emergency kit containing the hormone glucagon that counteracts hypoglycemia.
The next month, Lucy was in bed when she heard what she thought was an animal whimpering. She found her husband in a chair having a hypoglycemic seizure. Paramedics rushed him to the emergency room. His blood sugar was dangerously low, his medical records show. Ron told the doctors that the batteries had run low in his continuous glucose monitor and that he wasn’t eating regularly.
Back home, Lucy had what she called a “come to Jesus” talk with her husband. She was particularly worried about what could happen to him when she traveled. Like many people with diabetes, he could not always sense when his blood sugar was plunging, leaving him particularly vulnerable. She urged him to talk to his doctors about the best way to avoid these crises.
“He was in serious trouble before he ever knew it,” Lucy said. “It was driving me crazy.”
Dr Christopher Kodl was Carlson’s endocrinologist since 2015 at HealthPartners, a large health system based in Bloomington, Minnesota.
Kodl told Reuters that Carlson represented a challenging case for treatment. Carlson frequently experienced extreme highs and lows with his blood sugar, and was dependent on insulin injections. Kodl said that Carlson no longer fit the profile of type 2 diabetes and that his condition might have been better described as latent autoimmune diabetes, a disease that is closer to type 1. That meant Carlson’s body probably produced little or no insulin.
“We had to be aggressive with his insulin,” given how high his blood sugars would run, Kodl told Reuters. At the same time, “severe hypoglycemia was a risk we took very seriously.”
Carlson was also taking Novo Nordisk’s glucose-lowering drug Victoza. In its online marketing, the company says Victoza has helped many people “reach the American Diabetes Association’s A1c goal of less than 7.0%.” As for side effects, the company says: “Your risk for getting low blood sugar may be higher if you use Victoza with another medicine that can cause low blood sugar,” such as insulin.
In November 2017, six months after the ER visit, Carlson’s A1c was at 8.3%. Kodl increased his long-acting insulin to 30 units a day from 28 units and told him to call if he had frequent hypoglycemia.
At Carlson’s next appointment with a nurse practitioner, in early 2018, his A1c was down to 8.1%. “Not at goal but decreased from 8.3% on 11/20/2017; goal is less than 7% (without lows) to reduce risk of diabetes-related complications,” his records state.
Kodl said that the staff member’s note regarding an A1c goal below 7% was a mistake, but that Carlson’s course of treatment was still appropriate. At HealthPartners, the goal for patients in general is less than 8%, Kodl said.
“I never put (Carlson’s) goal at less than 7,” he said.
In August 2018, Carlson hit a car in a parking lot during another hypoglycemic episode. After that, in an attempt to keep his blood sugar in a healthier range, he started using a pump that attaches to the body and delivers insulin through the skin. He didn’t like it, especially the device’s alarms that kept him awake at night.
At times, he returned to injecting himself with insulin, occasionally taking too high a dose that resulted in hypoglycemia, his medical records show.
But the regimen did bring down his A1c. By December 2018, it was at 7.4%. Carlson’s diabetes was “mildly uncontrolled with some highs and lows, but not bad … Overall doing well,” Kodl wrote at the time.
At his last doctor visit, on June 14, 2019, Carlson’s A1c was 7.5%. Kodl said he decreased Carlson’s insulin dose slightly because he was responding well to treatment. Four weeks later, Carlson died in the parking lot of Al’s Center Saloon.
“It’s tragic,” Kodl said. “I think I did everything I could to treat him the best I could.”
After her husband’s death, Lucy Carlson couldn’t tend their farm on her own, and she eventually moved back to the Minneapolis area. She was diagnosed with post-traumatic stress disorder from the years of dealing with her husband’s hypoglycemic crises.
“I feel like his doctors were trying to help him, but what they were trying wasn’t working,” she said. “If Ron hadn’t been trying to reach that goal, he could still be here today.”
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