(WASHINGTON) FDA REPORT: Approval of the first drug for ‘Alzheimer’s Disease’ in 20yrs that shows substantial evidence that it reducesamyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients #AceHealthDesk report

#AceNewsReport – June.09: Aducanumab targets the underlying cause of Alzheimer’s, the most common form of dementia, rather than its symptoms:

US approves first new Alzheimer’s drug in 20 years: The US Food and Drug Administration (FDA) said there was “substantial evidence that aducanumab reduces amyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients”

Aldo Ceresa, who took part in the trial, says he’s “heading in the right direction”

Charities have welcomed the news of a new therapy for the condition.

But scientists are divided over its potential impact because of uncertainty over the trial results.

At least 100,000 people in the UK with a mild form of the disease could be suitable for the drug if it were to be approved by the UK regulator. 

Controversial trial

In March 2019, late-stage international trials of aducanumab, involving about 3,000 patients, were halted when analysis showed the drug, given as a monthly infusion, was not better at slowing the deterioration of memory and thinking problems than a dummy drug.

But later that year, the US manufacturer Biogen analysed more data and concluded the drug did work, as long as it was given in higher doses. The company also said it significantly slowed cognitive decline.

Aducanumab targets amyloid, a protein that forms abnormal clumps in the brains of people with Alzheimer’s that can damage cells and trigger dementia, including:

  • memory and thinking problems
  • communication issues 
  • confusion

‘Heading in right direction’

Aldo was one of just a handful of UK patients in the trial

Aldo Ceresa, who took part in the trial, first noticed problems differentiating between left and right 10 years ago.

After his diagnosis, the 68-year-old, who is originally from Glasgow and now lives in Oxfordshire, close to his family, had to give up his job as a surgeon. 

Mr Ceresa took aducanumab for two years before the trial was halted – and then had to wait almost as long for another trial, at the National Hospital for Neurology and Neurosurgery, in London, to begin.

“I’m quite happy to volunteer,” he says.

“I really, really enjoy this journey that I’m going through – and obviously the benefits I’m getting from it, which I’m very, very grateful for.”

He is convinced the drug has helped him.

“I feel like I’m not quite as confused. Although it’s still there, it’s not quite as bad. 

“And I’m just getting that bit more confident now.”

Mr Ceresa says his family has noticed improvements too.

“Before, if I was going to get something, I couldn’t remember, you know, where to find things in the kitchen. 

“That has become less of a problem,” he says.

“I haven’t caught up to the level that I was before – but I’m heading in the right direction.”Aldo’s brain was scanned regularly to see the effects of aducanumab

More than 30 million people around the world are thought to have Alzheimer’s, with most aged over 65.

For around 500,000 people affected in the UK, those eligible for aducanumab will be mostly in their 60s or 70s and at an early stage of the disease.

‘Very cautious celebration’

We need to keep our feet on the ground. 

This is not a miracle drug, nor a cure for Alzheimer’s but it is the first treatment which tackles the destructive mechanism in the brain that drives the destruction of neurons.

And that makes this a landmark moment.

But scientific opinion both here and the United States is divided. While some have welcomed approval, calling it a milestone for millions living with Alzheimer’s, others believe the drug will only have marginal benefits. 

Alzheimer’s charities say they will be pressing for an early decision in the UK – but that could take another year.

Lastly, we don’t know how much aducanumab will cost – it could be tens of thousands of pounds per patient each year. And if approved, access will be limited to those who’ve had specialist brain scans to confirm their diagnosis.

Despite all the caveats, this is moment for very cautious celebration. 

Prof Bart De Strooper, director of the UK Dementia Research Institute, said the decision to approve aducanumab marked “a hugely significant milestone” in the search for treatments for Alzheimer’s disease.

In the past decade, more than 100 potential Alzheimer’s treatments have flopped. 

But while he hoped it would prove a turning point for millions of people with the condition, he said there were “still many barriers to overcome”. 

Prof John Hardy, professor of neuroscience at University College London, said: “We have to be clear that, at best, this is a drug with marginal benefit which will help only very carefully selected patients.”

‘Grave error’

And Prof Robert Howard, professor of old age psychiatry at UCL, went further calling the drug’s approval “a grave error” that could derail the ongoing search for meaningful dementia treatments “for a decade”. 

He said the FDA had ignored data from the trial which showed no slowing of decline in cognition or function.

However, Alzheimer’s Society said the drug was “promising” but added it was “just the beginning of the road to new treatments for Alzheimer’s disease”.

Another charity, Alzheimer’s Research UK, said it had written to the Health Secretary Matt Hancock asking the government to prioritise the fast-track approval process for the drug in the UK.

Chief executive Hilary Evans, said: “People with dementia and their families have been waiting far too long for life-changing new treatments: It is now essential that regulatory authorities assess the evidence to decide whether they believe the drug is safe and effective for use in the UK.” Although many doctors are doubtful of aducanumab’s benefits, its US approval could be a huge boost to dementia research, which is traditionally underfunded compared with cancer or heart disease.Aldo has a magnetic-resonance-imaging (MRI) scan

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#AceHealthdesk report ….Published: Jun.09: 2021:

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#alzheimers-disease, #fda, #ucl, #washington

` Adolfo Suarez known for introducing ` Democracy ‘ into the country dies at aged 81 of in Hospital ‘

#AceWorldNews – SPAIN – 24 March – Former Spanish Prime Minister Adolfo Suarez, known for introducing Spain to democracy and becoming the first elected premier after the death of General Francisco Franco, passed away on Sunday at the age of 81.

Suarez died in a Madrid hospital after being admitted with pneumonia on Monday, AFP quoted family spokesman Fermin Urbiola as saying. Suarez suffered from Alzheimer’s disease which was diagnosed 11 years ago.

#ANS2014

#adolfo-suarez, #afp, #alzheimers-disease, #franco, #madrid, #spain, #spanish

Medicare Drug Plan: “How People Get Caught Up in the Medicare Drug Fraud”

#AceHealthNews says when you are elderly and infirm ,would you expect your doctor, drug company and advisers, to give you a “Medicare Drug Plan” you do not really need. Well according to this recent article that is exactly what happened to this person, under this “Medicare Drug Fraud” read the story ……………………………………………. below: comment and share

Centers for Medicare and Medicaid Services (Me...

Centers for Medicare and Medicaid Services (Medicaid administrator) logo (Photo credit: Wikipedia)

Story of the Events:

At another time in her life, Denise Heap might have tossed aside the insurance forms listing the drugs prescribed to her mother.

The “explanation of benefits” forms came like clockwork and didn’t require any action on her part.

But Heap was worried about her mother, Joyce, who was in the end stages of Alzheimer’s disease. Her health had inexplicably declined in the Los Angeles-area nursing home where she’d been living. So in April, when a thick envelope arrived from her mother’s Medicare drug plan, Heap scrutinized it.

What she found was frightening: Her 77-year-old mother was receiving a raft of medications Heap had never seen before.

As Heap began Googling the drugs, she realized something was drastically wrong. Either her mother was being given expensive medications for conditions she didn’t have 2014 such as breast cancer, asthma, emphysema and high cholesterol 2014 or something sinister was going on: Someone was using her mother to steal drugs.

“I flipped,” Heap said. Medicare’s prescription program, known as Part D, paid for more than “$10,000 worth of meds” in just three months, she said.

She first called Medicare to report her suspicions, she said, then the insurance company that managed her mother’s Medicare drug plan. Neither, she said, seemed very concerned.

“I was like, No, No, No,  You have to understand. I am trying to help you guys,'” she said.

Soon, Heap became convinced someone had stolen her mother’s identity while she was living at a nursing home run by an Armenian couple. The couple kept moving the location of the nursing home. And Heap believed they had over-sedated her mother with high doses of antipsychotics, inappropriately treating her blood pressure and allowing bed bugs to feast on her.

“I knew something crooked was going on,” said Heap, 59, who, with her mother, had co-founded a Holocaust education nonprofit in the 1990s to document stories of German resistance to Hitler.

Frustrated, Heap called Los Angeles County sheriff‘s Sgt. Steve Opferman, head of a task force specializing in prescription drug fraud. As soon as Heap began describing what had happened, Opferman said he knew her mother had been caught up in a fraud scheme involving Armenian organized crime.

Opferman and other investigators say criminals wager that patients and their families will not be like Heap. They bank on the fact that their victims 2014 Medicare beneficiaries 2014 will be too old or too sick to review insurance forms summarizing the medications and services billed in their names. And they count on the tendency of busy family members to give such forms a cursory glance, if that.

“Suffice it to say most people don’t pay attention, let alone know what they’re looking at,” Opferman said.

But Heap’s case, and others like it, shows the important role patients and their families can play in uncovering fraud within Part D. The program now covers 36 million seniors and disabled people and fills 1 in 4 prescriptions nationwide. Last year, it cost taxpayers $62 billion.

In an earlier report, ProPublica found that Medicare’s system for pursuing such fraud is so cumbersome and poorly run that schemes can quickly siphon away millions. Tips such as Heap’s can come into private insurers, which run Part D for Medicare, to contractors hired by Medicare to spot fraud, or to the U.S. Department of Health Human Services inspector general, which investigates health care fraud. But only a small percentage of cases funneled through this chain are prosecuted.

Reporters, using Medicare’s own data, were able to identify scores of doctors whose prescribing within the program followed known patterns of fraud: the cost of doctors’ prescribing jumped dramatically 2014 sometimes by millions of dollars 2014 from one year to the next and they chose brand-name drugs that scammers’ can easily resell.

Some doctors claimed that they 2014 like some of the patients involved 2014 were unwitting victims of identity theft. In other cases, federal investigators found, the doctors were paid for writing bogus or inappropriate prescriptions.

In a response to these findings, a Medicare official said more focus has been placed on fraud detection within Part D.

SpirivaThe drugs listed on Joyce Heap’s explanation of benefits forms are those most-desired in such fraud schemes. They included the asthma drugs Spiriva and Advair Diskus, for which her insurance plan paid nearly $270 a month each, the cholesterol drug Crestor, which cost nearly $170, and the antipsychotic Abilify, for which the plan paid about $920 for a 30-day supply.

Advair DiskusOpferman said Heap’s call launched an investigation that uncovered a large Part D scheme allegedly connecting the owners of the nursing home to a North Hollywood pharmacy operation, including evidence that other residents’ identities were used. A September search of the pharmacy where Heap’s mother’s prescriptions were filled found evidence that drugs were being relabeled or repackaged for resale, he said.

The doctor who prescribed the drugs has denied prescribing the majority of them, Opferman said. The case is now part of an ongoing investigation by California’s Department of Justice and his group, he said.

Opferman said investigators might never have known of the scheme without Heap’s tip.

Joyce Heap didn’t live long after her daughter unearthed the problems.

She improved briefly after moving to a new nursing home, where a doctor reduced her psychiatric medications, Denise Heap said. But she died of a heart attack on April 21.

In the months following her mother’s death, Heap said, she sent letters alerting Medicare and her mother’s insurer to the possible fraud. In July she wrote, “Please note that 100% of the prescriptions charged in April 2013 2026 are FRAUDULENT.”

Heap said she is “outraged” Medicare didn’t follow-up and ask detailed questions about her allegations. In fact, it was either her insurer or Medicare 2014 she can’t recall which 2014 that recommended she call the local sheriff if she was worried.

“I would have thought immediately they would have gotten on it,” she said.

But Heap said she is mostly tormented that she didn’t know such fraud schemes existed 2014 and that elderly people like her mother could become prey.

“It’s a hard thing to live with,” she said, tearfully. “I feel like I failed.”

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 Courtesy of:  Tracy Weber and Charles Ornstein ProPublica,  Dec. 31, 2013, 10:20 a.m.

 

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