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A Young Patient With Alzheimer’s Disease Was Hit by Medicare’s Refusal to Cover the Drug

Taylor Johnston

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PET scan of the human brain with Alzheimer’s disease.Credit: public domain

Jay Reinstein and Michele Hall do not seem to most people to be at risk of suffering from aging-related illnesses.

Reinstein is only 60 years old and Hall is 54 years old. Both have young adult children. However, both are already struggling to drive and can no longer work because their minds are not functioning as they once were.

They are two of the 200,000 Americans suffering from early-onset Alzheimer’s disease and have access to a potential treatment called Aducanumab on Tuesday aimed at slowing the progression of debilitating disease by Medicare. A group of people who received disastrous news when they proposed to limit.

When the government’s Medicare and Medicaid Service Center released the news, it was a bomb for Hall, Rheinstein and others like them. Despite living 700 miles away, the two delay the earth-destroying diagnosis that quit a satisfying job in their 50s and the inevitable cognitive decline caused by the disease. I am bound by both of these quests. Their greatest hope these days was that Biogen Inc.’s controversial treatment for Alzheimer’s disease, Aduhelm, could help improve the quality of life for young people.

“Terrible. Terrible,” said Hall, who was a corporate lawyer for the Manatee County Sheriff’s Office across the Sunshine Skyway Bridge, 30 minutes south of St. Petersburg, Florida. “I wasn’t ready for that. I didn’t see it coming.”

“I’m one of the hundreds of thousands of people who can make a profit, and I can’t,” said Rheinstein, who worked as Assistant City Manager in Fayetteville, North Carolina until a few years ago. .. “You have diminished hope. What are you doing now?”

Overall, about 6 million Americans suffer from Alzheimer’s disease, and about half of them say the National Institute on Aging may have mild symptoms. This is the target group for aducanumab. But it’s a particularly cruel blow to those at the height of their lives. Hall and Reinstein are involved in a network of disease advocates who have expressed anger at Medicare’s preliminary decisions. The Alzheimer’s Association calls it “shocking discrimination” and only a “privileged minority” remains capable of receiving monthly drug injections.

Under the age of 65, Hall and Rheinstein are eligible for Medicare because of their condition. The unusual proposal to not completely cover aducanumab reflects Medicare’s suspicion that the drug does better than harm. The Food and Drug Administration approved the infusion last June without clear evidence that it worked, resulting in a fire storm of bad press and congressional investigations. The drug also has serious side effects such as headaches, dizziness, falls and even cerebral hemorrhage.

Still, despite all the shortcomings, Reinstein and Hall were eagerly awaiting treatment opportunities. What else are you going to do when you don’t know your grandchildren or face a future that needs help in every little job?

“I want to be a guinea pig,” Reinstein said. “We are only looking for opportunities.”

Reinstein and Hall met about six months ago through Alzheimer’s Association and every two weeks through FaceTime. Hall recently joined one of Reinstein’s support groups. It is also part of an observational study called the Longitudinal Early-onset Alzheimer’s Disease Study (LEADS), funded by the National Institute on Aging, with the goal of learning more about the characteristics of people aged 40 to 64 years with cognitive impairment. increase.

The hall journey began after a meeting at work, when it was difficult to find the right words to use in a conversation, but something really went wrong in a clinic seeking treatment for a hand injury. I knew there was: she looked down at the shape she should have filled in and couldn’t understand any of it. She looked at the pen’s cup at the front desk and spelled “cup” to try to focus. I couldn’t do it after 30 minutes, so I called my husband and hurriedly asked for help.

“Oh, another thing that made it clear,” she said, then stopped and looked at her husband Doug before continuing to comment. “What was my title?”

“President of the Florida Police Bar Association,” he replied. He filled in the blanks for her many times.

She was planning to give a speech at the 2019 Group’s annual convention, but “Nothing came. I decided I couldn’t work anymore.” Eventually, she underwent a spinal puncture at the Mayo Clinic in Jacksonville, Florida, and was diagnosed catastrophically. Hall thought of suicide and asked a law enforcement friend where to get the gun. She told her three children in her twenties that she didn’t want to show her waste.

“The first few months were really miserable,” she said. “It was hard because suddenly you see yourself leaving.”

She and Rheinstein are riding an emotional roller coaster with Aducanumab. They closely tracked the progress of aducanumab through the approval process. The approval process was itself full of ups and downs as the drug appeared to have failed and was resurrected. Later, when the FDA approved the monthly injections last year, a rare hope was glimpsed.

Hall’s husband said he knew that aducanumab was not a mysterious drug. “But that will help stabilize her for six months,” he said.

“Is it better than doing nothing? I think so,” he said.

The FDA justified the approval of Aducanumab because of the urgent need for treatment of Alzheimer’s disease. Although it has no apparent effect and is at risk of serious side effects, Biogen has set the price of this drug at $ 56,000 per year.

Based in Cambridge, Massachusetts, the company recently halved its price due to blowbacks and sluggish sales. Biogen said Tuesday that Medicare’s decision to limit the scope of aducanumab to patients in clinical trials would make the majority of patients inaccessible to treatment and “decline without hope of intervention.” It is not yet clear which exams are eligible for Medicare.

Aducanumab is to be used only in people with mild cognitive impairment. Hall and Reinstein were afraid that cognitive abilities could be more than mildly impaired before trying the drug.

Hall decided not to wait anymore at the end of last year. On December 29, she and her husband drove for 30 minutes to a small infusion center in St. Petersburg, a reservation promoted by the University of South Florida Healthbird Alzheimer Center and Research Institute.

The needle fell into her hand and the infusion lasted about an hour. She had her own room with a reclining chair, where she watched a low and order rerun. “Now I’m completely fine,” she said at the beginning of the infusion. “We were waiting for this.”

Patients start aducanumab in small doses and eventually increase in dose. The initial dose is relatively affordable. The hall will continue to receive monthly infusions for at least a few more months. She is uncertain how she manages the higher costs of increased doses if Medicare does not cover them.

The government will set a 30-day comment period on the interview proposal and make a final decision in April. Reinstein has set up a non-profit organization called Voices of Alzheimer’s to meet with Medicare professionals and change their minds within two weeks.

This is in stark contrast to what he had prepared until Tuesday’s decision. Just last week, Jay drove from Raleigh, where he lives, to Georgetown University in Washington, DC. This is one of the locations of the LEADS study, where we obtained PET scans to check for the presence of abnormal protein deposits called amyloid plaques in the brain. Requirements for receiving Alzheimer’s disease markers and aducanumab. He will get results later this week, and although he doesn’t know how he will go, he desperately wants to find a way to get aducanumab.

Jay has been suffering from anxiety and depression attacks since his diagnosis about three years ago. Still, he manages to hide his pain. His outward persona is charismatic and self-respecting. He still co-sponsors a weekly radio show called “Honest Conversation between Keb and Jay” with his friend and community activist Kevin Brooks at the local gospel music station in Fayetteville.

But in a quiet moment, it’s a different story. “A lot of worries. Sometimes I get up at night and worry. I hate it.” Reinstein said there aren’t many resources for people with early-onset Alzheimer’s disease, finding someone to share their experiences with. Will help.

FaceTime sessions with Hall are more important than ever. “You know you’re not alone,” Reinstein said.

Medicare limits coverage for Alzheimer’s disease treatment of $ 28,000 per year

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Quote: A young Alzheimer’s disease patient was hit by Medicare’s refusal to cover the drug (January 14, 2022).

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A young patient with Alzheimer’s disease was hit by Medicare’s refusal to cover the drug

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Policy

Coroner Spotlights Domestic Violence, Homelessness, Fentanyl Crises in Annual Report

Taylor Johnston

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More than a third of the 61 people murdered in El Paso County last year were killed during a domestic or family violence situation.

Seven homeless people froze to death on the streets of Colorado Springs last year, and another five died from exposure to the elements from Jan. 1 through May 31 of this year.

And while youth suicides declined dramatically last year, more adolescents as well as adults are unintentionally dying from fentanyl, according to the 2021 El Paso County Coroner’s annual investigative-deaths report, released Tuesday.

“As our population grows, we’d expect to see all categories increase incrementally, but there are areas where we’ve left that trajectory,” said Dr. Leon Kelly, El Paso County coroner and chief medical examiner.

Fentanyl, a prescription pain drug, constitutes a “gross deviation” from predicted increases, Kelly said, largely because the synthetic opioid has wormed its way into many illicit street pills and often is ingested unknowingly.

That’s evidenced by the number of fentanyl-related deaths doubling for each of the past five years, he said.

Last year’s five accidental fentanyl-related deaths among children younger than age 18 surpassed the number of teen suicides last year, which fell from a record-tying high of 15 deaths in 2020 to only four deaths in 2021, statistics show.

“The big tipping point came when fentanyl went from an illegally trafficked drug to being stamped and masked as other medications,” Kelly said. “It’s easily carried, sold to kids in pills, and the cost has gone down because of the massive supply, so the barrier has been broken.”

Across the board, accidental drug-related deaths increased by 22% last year, with 107 methamphetamine deaths and 99 fentanyl deaths. Fentanyl also was found in a quarter of the meth overdoses.

Other trends that emerged from 2021 autopsied deaths:

o El Paso County saw a large increase in total firearms-related fatalities, jumping from 133 in 2020 to 167 last year.

o Homicides increased from 55 in 2020 to 61 in 2021, six of which occurred in a single mass-shooting event at a family gathering on Mother’s Day last year.

o The average age of the 78 people who died while homeless was 49 years old. Deaths of homeless during the first five months of this year are outpacing last year, with 48 deaths through through May 31.

o At least one military veteran or active-duty service member died by suicide every week in El Paso County last year.

o 58 people died in motor vehicle accidents, a decrease from 78 in 2020.

o However, 20 pedestrians and five bicyclists were killed in 2021, compared with 13 pedestrians and seven bicyclists in 2020.

o There were an additional 96 accidental deaths due to falls predominantly among the elderly, with an average age of 78.6 years, which were investigated without autopsy.

o 398 people died of natural causes, with cardiovascular disease as the top reason, causing 170 deaths, and chronic alcoholism attributed to 64 deaths.

The same type of prevention work that El Paso County has poured into reducing teen suicides needs to be deployed to counter the use of fentanyl, Kelly said.

Efforts are underway, he said, with the 4th Judicial District Attorney’s Office convening community leaders and experts to study lessons learned from youth suicide prevention that can be applied in attacking the newest threat to children’s lives.

Success in lessening youth suicides came because representatives from all sectors became part of a concerted push, Kelly said, after El Paso County ranked highest in the state and near the top in the nation for self-inflicted fatalities.

“Every conceivable youth-facing organization, from faith-based, to Inside Out (a lesbian, gay, bisexual and transgender organization that serves youth), to schools, to parents to law enforcement to mental health professionals identifying what was going on and what they could bring to the table,” Kelly said.

Face It Together, a nonprofit that provides peer coaching for adults with addictions and support for families, has seen “a great need” and an increase in people seeking help with opioid addiction such as fentanyl, said CEO Wendy White.

The organization opened its first Colorado office last April in Colorado Springs and also offers remote services nationwide.

“The power of using peers helps remove the shame and stigma, and breaks down barriers, allowing people to share their situation and add more tools to their toolbox,” White said.

She said she’d like to see a “harm-reduction” approach with test strips provided for drug users to determine the toxicity level of pills they might ingest.

The public now can buy Narcan, an antidote for people overdosing on opioids, at pharmacies without a prescription, said Dr. Eric Stein Bronsky, an emergency medicine physician with Penrose-St. Francis Health Services in Colorado Springs. Emergency medical technicians and police also carry doses, which is easily administered in a nasal spray, he said.

Also, hospitals dispense Narcan when discharging patients who are on pain medication, Bronsky said.

“Not all opiate doses are illegal; a tremendous amount of overdoses come from prescribed medication, and Grandma or Mom or Dad stacking pain medicine, or their body having a harsher response that can send them into respiratory decline,” he said.

Because fentanyl is hidden in pain pills that look like OxyContin or Percocet, for example, and is more potent than other drugs, opiate abuse won’t abate, Bronsky believes, until it’s seen as a health care crisis and not a legal problem.

“They can arrest more dealers, put more people in jail, but until we’re willing to concentrate on what it is — a health care crisis — people won’t be willing to solve it,” he said. “People are willing to solve a health care crisis.”


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Policy

Defense Contractor With 200-person Office in Colorado Springs Approves Company Merger

Taylor Johnston

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Vectrus shareholders approved a merger with The Vertex Co. to create the new military powerhouse, V2X, a $3.4 billion revenue company to be based out of northern Virginia, Vectrus announced in a news release Wednesday.

The transaction will give Vertex shareholders nearly two-thirds ownership of the company and Vectrus shareholders one third, creating one of the nation’s 20 largest defense contractors with 14,000 employees in 300 locations worldwide.

“Today’s (Wednesday’s) overwhelming approval marks a significant step toward completing our merger with Vertex, and creating one of the leading providers of critical mission solutions and support to defense clients globally,” Chief Executive Officer of Vectrus Chuck Prow said in the release. “Vectrus and Vertex — together as V2X — will be better positioned to meet the mission-essential needs of our clients while delivering cost efficiencies, increased security and resiliency, with more strategic use of resources.”

The melding of the two companies is likely save about $20 million a year by eliminating duplicated information technology, computer networks along with “some consolidation of people,” as V2X tries to tackles a contract backlog of more than $11 billion reaching into 2027.

Vectrus’ Colorado Springs office of 200 employees that focuses on sales, finance and human resources will stay in place, Vectrus Vice President Michael Smith confirmed.

Vertex also operates an office near the Colorado Springs Airport that supports a contract the company manages at a radar station in Alaska that feeds data to the North American Aerospace Defense Command (NORAD).

Summer jobs help area youths earn cash, develop skills

Prow will become CEO, Vectrus Chief Financial Officer Susan Lynch will hold the same post in the combined company and Vectrus board members will hold six of the 11 seats on the combined board, including the chairman’s post. Vertex CEO Ed Boyington will serve on the board and remain with the combined company until retiring after an unspecified transition period.

Vectrus, which specializes in logistics, information technology maintenance and operating military bases, is slightly larger than Vertex.

Vectrus generates about $190 million more in revenue and employs 2,400 more people, mostly at military bases around the world. Vertex specializes in aircraft maintenance, systems engineering and training.

“We thank all of our stakeholders for their continued support and look forward to completing the pending combination so we can begin unlocking the incredible potential of our combined platform,” Prow said.


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Wildlife Officials Warn of Possible Increase in Bear Encounters This Year

Taylor Johnston

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Colorado Parks and Wildlife is warning the public of the possibility of increased bear encounters this summer and fall because of late season storms that struck Colorado in May.

Bears’ diets depend on what kinds of foods are seasonally available such as grasses, berries, fruits, nuts and plants. These food sources can be disrupted in years that are abnormally dry or when there is a late frost like this year, wildlife officials said.

“We certainly see a correlation between annual failures of natural bear food sources and years with higher human-bear conflict rates,” said Mark Vieira, the state’s carnivore and furbearer program manger. “When natural food sources are scarce, as the smart flexible eaters that bears are, they tend to spend more time near humans.”

Bear encounters last year were down 28% compared to the previous two years. But encounters are expected to rise because of concerns about the late freeze that could limit food sources.

Wildlife officials said a late freeze occurred in May 2017 and led to a high conflict year where 109 bruins were relocated and 190 others were euthanized.

Mountainous and foothill areas from western Douglas County to Larimer County have already reported areas with frost damage to crops, while other forages continue to recover from wildfires, such as the Cameron Peak fire in 2020 — the largest in the state’s history.

“We have such a large fire footprint that the damage is already done as far as worrying about the soft mass production,” Wildlife Officer Shane Craig said. “I’m sure there were pockets of natural forage that survived, but we have already skated on our luck to get us past 2021.”

Wildlife officers are concerned about the number of gamble oak crops that died during the late season freeze. The crop produces acorns that become a vital source of food for bears as they prepare for winter and are in hyperphagia where they consume 20,000 calories a day.

Wildlife officials said nearly all emerging gamble oak crops above 6,800 feet in western Douglas County died in the late season freeze, but chokecherries and plums survived.

“We’ll be okay for the short (term), but in the 7-8 years I’ve been in my district I’ve never seen an oak dieoff like this,” Wildlife Officer Melanie Kaknes said in a news release. “The bears will have to figure out something because they have to put on weight for the winter. This dieoff (is) going to be pushing bears down in elevation and likely into towns.”

In western Jefferson County and eastern Park County, officials are concerned about the status of higher elevation crops.

“It is too early for me to know how things will pan out for the higher elevation stuff,” Wildlife Officer Dawson Swanson said in a news release. “On the good side we are getting some moisture that we desperately need, let’s just hope things did not freeze up high.”

Most adult bears survive year-to-year even if there is poor food availability.

Wildlife officials reminded residents and visitors to be aware of their surroundings and follow proper guidelines on living appropriately with bears.

These guidelines include:

Keep garbage in a well-secured enclosure.Only put out garbage on the morning of pickup; bring empty cans inside before dark.Use a bear-resistant trash can or dumpster. These are available online or from your trash hauler.Clean all garbage cans regularly to keep them odor free. The scent of ammonia can also deter bears.Take down all bird feeders. Bird feeders are a major contributor to bear/human conflicts and resulted in 1,073 conflicts between 2019 and 2021. Don’t leave pet food or stock feed outside.Install and test electric fencing to protect chicken coops, bee hives and livestock enclosuresKeep garage doors and windows closed and locked

For additional information about bears and guidance, click here.


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Original Source: gazette.com

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