Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent

He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent | Pharmaguy's Insights Into Drug Industry News | Scoop.it

His face is everywhere: in TV commercials during late-night comedy shows, in the pages of Wired and Politico, on a billboard at the airport near Washington, D.C.

 

Brian Kursonis, who was diagnosed last year with early-onset Alzheimer’s at age 55, is a star of the drug industry’s “Go Boldly” campaign — a sophisticated PR push, costing tens of millions a year, to highlight pharma’s commitment to develop cures for dreaded diseases.

 

The ads might improve pharma’s battered reputation. But behind the soft lighting and inspiring music, the patient who’s helping anchor the campaign says his life is falling apart.

 

He is living alone, after a nine-year relationship broke up as his memory deteriorated. He had to give away his beloved dogs. He loves fly-fishing, but forgets how.

 

And he is fast running out of money.

 

Kursonis hopes he can find a way to earn a living as an advocate, but if money doesn’t come in soon, he won’t be able to make the December rent on his spartan apartment in a suburb outside Charlotte, N.C. He fears he will soon be homeless, his best option the men’s shelter in downtown Charlotte.

 

Kursonis’s story highlights the complicated, often heartbreaking realities that compound the challenges of living with a disease like Alzheimer’s.

 

In the “Go Boldly” ads — which were funded by the drug industry lobbying group PhRMA — he’s paired with a scientist who promises to bring an Alzheimer’s drug to patients in her lifetime. Even if she succeeds, a long shot in a field that has been marked by failure after failure, Kursonis knows it will likely be too late to help him and millions of other patients in the grip of the degenerative disease.

 

Now, he’s begun speaking candidly about his challenges — both on his blog and in interviews with STAT — in hopes of raising awareness and building a new career as a patient advocate.

 

“I want people to know, if I disappear, that at least I tried,” Kursonis said.

 

Further Reading:

Pharma Guy's insight:

The only option is for him to become a paid Alzheimer's patient advocate. Good luck with that! There will be many more patients vying for that opportunity.

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Failed Alzheimer’s Trial Does Not Kill Leading Theory of Disease

Failed Alzheimer’s Trial Does Not Kill Leading Theory of Disease | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A drug that was seen as a major test of the leading theory behind Alzheimer’s disease has failed in a large trial of people with mild dementia. Critics of the ‘amyloid hypothesis’, which posits that the disease is triggered by a build-up of amyloid protein in the brain, have seized on the results as evidence of its weakness. But the jury is still out on whether the theory will eventually yield a treatment.

Proponents of the theory note that the particular way in which solanezumab, the drug involved in the trial, works could have led to the failure, rather than a flaw in the hypothesis itself. And many trials are ongoing to test whether solanezumab — or others that target amyloid — could work in people at risk of the disease who have not yet shown symptoms, or even in people with Alzheimer’s, despite the latest negative result.

“I’m extremely disappointed for patients, but this, for me, doesn’t change the way I think about the amyloid hypothesis,” says Reisa Sperling, a neurologist at the Brigham and Women’s Hospital in Boston, Massachusetts. She is leading one of several ongoing ‘prevention’ trials that is testing solanezumab, and other drugs that aim to reduce the build-up of amyloid ‘plaques’, in people at risk of developing Alzheimer’s.

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NIH Should Stop Funding Underperforming Big Ideas in Medical Research

NIH Should Stop Funding Underperforming Big Ideas in Medical Research | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[A JAMA Viewpoint article] For several decades now the biomedical research community has pursued a narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead to transformative improvements in health care and human health.

 

None of these popular topics has had any measurable effect on population mortality, morbidity, or life expectancy in the United States. The improvements of the past decades in these outcomes, which have been substantial but are now stalling, have largely reflected improvement in nonmedical aspects of everyday life and the operation of broad-based public health and classic prevention efforts, such as curtailing smoking, that are undervalued as outmoded and old-fashioned by the narrative. The anticipation that improvements in medical care and outcomes derived from big ideas will reduce costs also seems unlikely given the high costs of applying targeted therapeutic interventions to small numbers of people based on complex and expensive technologies, as well as the inevitable overdiagnosis and overtreatment that follows from more intensive monitoring. Similarly, EHRs may increase health care costs due to their ability to enhance revenue capture and as a result of unanticipated security and upgrade expenses. What historical precedent is there that adoption of vast new oversophisticated technology reduces costs? Eventually, what is the definition of success and over what time frame?

 

NIH deinvestment in preclinical research promises that clearly do not deliver will allow more funding to be directed toward work of clear public health importance and for imaginative biomedical research that is truly innovative and not constrained by current narratives.

Pharma Guy's insight:

An example of a big idea soaking up gov't funding is current Alzheimer's Disease research that focuses on one big idea: clearing the sticky plaque gumming up patients' brains is the solution (read, for example, "Another Alzheimer's Clinical Trial Failure"; http://sco.lt/4gvYGX and “Can Pharma Cure Alzheimer's Disease?”; http://bit.ly/1gmpt1D)

 

Despite repeated failures like this, there is a clamor for even more funding of such blind-alley research. Read, for example, “Lack of Alzheimer's Disease Research Funding Due to #Pharma Failures”; http://sco.lt/75EmKf 

 

It's unlikely that NIH will reinvest in these efforts due to political pressure from interest groups such as patient advocates and drug company investors.

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When It Comes to Alzheimer's Disease Research Trump is a Black Box, Hilary an Open Book

When It Comes to Alzheimer's Disease Research Trump is a Black Box, Hilary an Open Book | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When Hillary Clinton announced in December that she wanted a big increase in Alzheimer’s research, she did it in typical Clinton fashion — with a major speech and a six-point plan, led by a specific commitment of $2 billion a year in federal funds to find a cure by 2025.

 

When Donald Trump announced his own support for Alzheimer’s research last summer, he did it because someone asked him a question at a town hall. And his response was typical Trump. He assured the New Hampshire audience that Alzheimer’s was a “total top priority” for him — a bold promise with no specifics and no follow-up.

 

These are the two paths that US medical research could take now that the lineup for the November presidential election is settled. The fate of the Obama administration’s significant investments in biomedical research will end up in the hands of either a candidate with a long, wonky track record on health and medicine — with mixed results — or the candidate whose views are an almost complete mystery.

 

Clinton “really knows what’s going on and is a policy wonk on medical research as well as health care,” said Mary Woolley, president of Research!America, a coalition of groups that promote medical research. Trump, however, has such an “in the moment” approach to medical research — almost never raising the issue unless someone asks him about it — that it will be impossible to know what he’d do until people ask him more questions, she said.

 

Paul Offit, the chief of the division of infectious diseases at Children’s Hospital of Philadelphia, puts the choice in more stark terms.

 

“I think it is fair to say that Donald Trump is a black box. He says one thing one day and the opposite the next,” Offit said. “So he certainly scares me far more than Hillary Clinton, who has generally supported public health.”

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HHS Says Namenda "Hard Switch" Will Cost Medicare a Minimum of $6 Billion

HHS Says Namenda "Hard Switch" Will Cost Medicare a Minimum of $6 Billion | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Actavis said last month that it stood to lose $200 million in sales if an appeals court didn't let it force patients over to a new, patent-protected version of Alzheimer's treatment Namenda before generics hit. But if the court does allow the so-called hard switch? The federal government stands to lose much, much more.


The cost of that move to Medicare and its beneficiaries? A $6 billion spending increase between 2015 and 2024--at the least, the department said.


"We are concerned that the measures taken by Actavis undermine competition and result in excess payments by consumers and taxpayers," it wrote in the report. "… Actavis' planned conduct would exacerbate the problem of financing health care for the elderly."

Pharma Guy's insight:


HHS concludes its report saying:


"The planned withdrawal from the market of Namenda IR appears designed to force a highly- vulnerable population suffering from a severe chronic illness to shift to a reformulated version of the product for the purpose of limiting generic competition and preserving monopoly profits. Actions of this type undermine consumer choice and generic competition in prescription drug markets.


"If Actavis curtails production of Namenda IR, consumer welfare will suffer due to a combination of fewer choices and diminished price competition. The federal government in particular would overpay relative to what it would have paid had the generic product been permitted to freely compete with the newer reformulated product. Such practices stress public budgets and reduce the ability to promote value-based health care use. As a result, Actavis’ planned conduct would exacerbate the problem of financing health care for the elderly."


Way to go, "patient-centric" pharma! 

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Lack of Alzheimer's Disease Research Funding Due to #Pharma Failures

Lack of Alzheimer's Disease Research Funding Due to #Pharma Failures | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Drug companies are retreating from the search for a dementia cure after “repeated and costly failures” to develop a breakthrough drug, a major report has warned.


The report was presented at Wish 2015, a gathering of health experts in Doha, Qatar. Wish is an initiative of the Qatar Foundation, the charitable organisation linked to the Gulf state’s ruling al-Thani family. Its executive chair is the former Labour health minister Lord Darzi. He said the social and economic burden of dementia was already clear.


“Yet the future costs to societies and economies will be enormous without significant intervention now,” he added.


Wish’s Dementia Forum is chaired by Ellis Rubinstein, president of the New York Academy of Sciences. His report states: “Experts speculate that the lack of funding [for dementia research] has created an environment of competition in academia and that repeated and costly failures in drug development have created funding fatigue in donors and pharmaceutical companies.


“They believe this has caused the field to become more conservative, and limited unconventional strategies and parallel drug discovery opportunities.”

Pharma Guy's insight:


Blame patient advocates:


The former head of Pfizer's R&D, John LaMattina, offered the following as a possible answer for Pfizer's failed attempt to bring an AD drug to market:

“Perhaps the answer lies the fact that there were groups of stakeholders who desperately wanted bapi to advance. AD [Alzheimer's Disease] patient advocacy groups would top the list. These people, who are doing their utmost to help find any treatment for this disease, would have been outraged had bapi been dropped at phase 2.


Read: The $400 Million bapi Drug Failure: Are Patient Advocates the Scapegoat?

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Actavis Loses Ruling on Namenda "Hard Switch" Marketing Tactic

Actavis Plc was ordered to continue to provide the immediate-release version of its Namenda Alzheimer’s drug in a win for New York Attorney General Eric Schneiderman, who sued the company in September.


Via TwoFour Insight Group
Pharma Guy's insight:


The decision may be most troubling for fellow companies looking to pursue the hard switch as a market-share shield, he wrote, noting that the district and appeals courts' direction suggests it would be "increasingly difficult" to pull it off.


Companies will likely have to demonstrate no hardship for patients and business rationale which differs from attempting to force the market to their new product.

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TwoFour Insight Group's curator insight, December 12, 2014 10:26 AM
Similar to DPCO 2013' s authority to not allow discontinuation of a product?
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Many Patients Taking Drugs for Alzheimer’s Do Not Actually Have the Disease

Many Patients Taking Drugs for Alzheimer’s Do Not Actually Have the Disease | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A significant portion of people with mild cognitive impairment or dementia who are taking medication for Alzheimer’s may not actually have the disease, according to interim results of a major study underway to see how PET scans could change the nature of Alzheimer’s diagnosis and treatment.

The findings, presented Wednesday at the Alzheimer’s Association International Conference in London, come from a four-year study launched in 2016 that is testing over 18,000 Medicare beneficiaries with MCI or dementia to see if their brains contain the amyloid plaques that are one of the two hallmarks of the disease.

So far, the results have been dramatic. Among 4,000 people tested so far in the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, researchers from the Memory and Aging Center at the University of California at San Francisco found that just 54.3 percent of MCI patients and 70.5 percent of dementia patients had the plaques.

A positive test for amyloid does not mean someone has Alzheimer’s, though its presence precedes the disease and increases the risk of progression. But a negative test definitively means a person does not have it.

 

Further Reading:

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Scientists Frustrated by the Conventional Theory of Cause of Alzheimer's Disease

Scientists Frustrated by the Conventional Theory of Cause of Alzheimer's Disease | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the wake of disappointing results this week for yet another experimental Alzheimer’s drug (read “Another Alzheimer's Clinical Trial Failure”; http://sco.lt/4gvYGX), scientists who have toiled for decades to understand the devastating disease expressed frustration and even anger that their field has not made more progress toward a cure.

 

To a growing number of scientists, the problem isn’t that there’s been too little time to make meaningful progress against a hugely complicated disease that strikes an organ unrivaled for its complexity. It’s that the field has made many missteps, that its leaders stifled research that deviated from the dominant theory of what caused Alzheimer’s, and that it was too easy to count as progress journal papers rather than advances that help patients.

 

“People got into a certain mindset, had a certain set of expectations, and then proceeded on those expectations for 35 years,” said Dr. Daniel Alkon, a 30-year veteran of the National Institutes of Health and now scientific director of the Blanchette Rockefeller Neurosciences Institute in West Virginia. “It was the expectation that amyloid plaques and tau tangles kill brain synapses and neurons,” and that eliminating them will stop the disease, he said. “There were a lot of clues that wasn’t true, but because of their mindset, people didn’t see those clues.”

 

The idea that Alzheimer’s is caused by sticky clumps of protein called amyloid plaques, which destroy the synapses between brain neurons, dates to the 1980s, and key genetic mutations that cause early-onset forms of it were discovered in the 1980s and 1990s. The discovery that a protein called tau forms “neurofibrillary tangles” that are toxic to neurons dates to 1986, but for decades was overshadowed by the amyloid idea. The animosity between the two camps grew as bitter as a religious war, earning it the name “tauists vs. baptists” (the “ba-” stands for beta-amyloid, the formal name of the protein).

Pharma Guy's insight:

This is an example of a big idea soaking up gov't funding; i.e.,  current Alzheimer's Disease research that focuses on one big idea: clearing the sticky plaque gumming up patients' brains is the solution (read, for example, "Another Alzheimer's Clinical Trial Failure"; http://sco.lt/4gvYGX and “Can Pharma Cure Alzheimer's Disease?”; http://bit.ly/1gmpt1D)

 

Despite repeated failures like this, there is a clamor for even more funding of such blind-alley research. Read, for example, “Lack of Alzheimer's Disease Research Funding Due to #Pharma Failures”; http://sco.lt/75EmKf 

 

It's unlikely that NIH will reinvest in these efforts due to political pressure from interest groups such as patient advocates and drug company investors.

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Another Alzheimer's Clinical Trial Failure

Another Alzheimer's Clinical Trial Failure | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A closely watched treatment for Alzheimer’s disease came up short in a late-stage trial, marking the latest setback in a field wracked by years of failure.

The drug, from biotech company TauRx, did no better than a sugar pill at improving patients’ scores on tests of cognitive and physical function, according to data presented early Wednesday at the Alzheimer’s Association International Conference in Toronto. The study looked at roughly 900 patients with mild to moderate forms of Alzheimer’s.

“I must say I’m disappointed by the results,” said Dr. David Knopman, a Mayo Clinic neurologist not involved with the study.

Pharma Guy's insight:

Despite repeated failures like this, there is a clamor for even more funding of such blind-alley research. Read, for example, “Lack of Alzheimer's Disease Research Funding Due to #Pharma Failures”; http://sco.lt/75EmKf which reports how some in the drug industry actually blame patient advocates for pushing trials of drugs that have little hope of succeeding.

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Is It Alzheimer's Disease or ADHD? Whatever! A New Market for Vyvanse.

Is It Alzheimer's Disease or ADHD? Whatever! A New Market for Vyvanse. | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Once seen as a disorder affecting mainly children and young adults, attention deficit hyperactivity disorder is increasingly understood to last throughout one’s lifetime.

In 2012, in one of the only epidemiological studies done on A.D.H.D. in older adults, a large Dutch population study found the condition in close to 3 percent of people over 60.

Yet we know little about how A.D.H.D. affects older people, or even who has it.

“We hardly have any literature,” said Dr. Thomas Brown, associate director of the Yale Clinic for Attention and Related Disorders at the Yale School of Medicine. Almost none of the clinical trials and epidemiological studies on A.D.H.D. have included people over 50. “But I see quite a few people turning up in my office with these complaints. It’s reasonable to assume that a lot of elderly people have A.D.H.D.”

Heightened awareness of A.D.H.D. is bringing increased referrals of elderly adults to specialty clinics. “A child had been treated, then a parent, then everyone started looking at Grandpa, and saying, ‘Oh my gosh,’ and they would bring him in,” said Dr. Martin Wetzel, associate clinical professor of psychiatry at the University of Nebraska Medical Center.

Yet many general practitioners and mental health experts mistake symptoms like impaired short-term memory or an inability to stay focused on a task as something else.

“We do a horrible job of training health care professionals about adult A.D.H.D.,” Dr. Wetzel said.
Pharma Guy's insight:

This article could have been written by Shire, which has been trying to make a case for treating ADHD in adults for a long time. Read, for example, Shane Victorino: Adult ADHD Poster Boy;  http://bit.ly/pgdaily121513-1C I'm sure many docs read read the Well blog (the origin of this piece) and be convinced to prescribe Vyvanse off-label to treat elderly patients who they originally thought had early signs of Alzheimer's Disease.  

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Psychiatric Drug Overuse Is Cited by GAO Study

Psychiatric Drug Overuse Is Cited by GAO Study | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Antipsychotic drugs are frequently prescribed to older adults with dementia. GAO's analysis found that about one-third of older adults with dementia who spent more than 100 days in a nursing home in 2012 were prescribed an antipsychotic, according to data from Medicare's prescription drug program, also known as Medicare Part D. Among Medicare Part D enrollees with dementia living outside of a nursing home that same year, about 14 percent were prescribed an antipsychotic. (See figure.)


Note: GAO excluded individuals diagnosed with schizophrenia or bipolar disorder because the Food and Drug Administration (FDA) has approved certain antipsychotic drugs for the treatment of these conditions.

Pharma Guy's insight:


According to NYT: The findings will be released Monday by the Government Accountability Office, an arm of Congress, and come as the Obama administration has already been working with nursing homes to reduce the inappropriate use of antipsychotic medications like Abilify, Risperdal, Zyprexa and clozapine. But in the study, investigators said officials also needed to focus on overuse of such drugs by people with dementia who live at home or in assisted living facilities.

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No Namenda for You!, Says Actavis CEO to Patients

No Namenda for You!, Says Actavis CEO to Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Actavis is betting it can switch a large number of patients to a newer Alzheimer's pill from an older version.


While Actavis is busy fighting a court battle over marketing plans for a newer version of its big-selling Alzheimer’s pill, the drug maker is also working hard to convert many patients from its older version of the drug before generic rivals emerge later this year.


At the moment, the newer Namenda XR accounts for about 40% of all prescriptions written for both the old and new versions of the drug. But Actavis believes Namenda XR can capture as many as 70% of prescriptions by July, when generic copycat versions of the older Namenda IR become available.


But to what extent will it succeed in reaching that goal? This is unclear due to the ongoing legal fight. The drug maker, you may recall, is currently battling with the New York State Attorney General, who filed a lawsuit claiming the switching effort violates antitrust law. The original plan was to remove Namenda IR from the market and force patients to take the newer Namenda XR.


But a federal court judge last month issued a preliminary injunction that prevented Actavis from discontinuing sales of its older Namenda IR (see story here). Actavis appealed the ruling and a hearing is scheduled for next month in which the drug maker hopes to convince a federal appeals court to lift the preliminary injunction.


If that doesn’t happen, “Actavis will have to use marketing strategies – detailing, differential pricing, and direct-to-consumer advertising to convert as much of the market to Namenda XR as possible before generics enter,” writes Sanford Bernstein analyst Ronny Gal in an investor note. Actavis, in fact, has already begun a consumer advertising campaign to speed the switch.

Pharma Guy's insight:


Meanwhile, here's an example of how pharma CEOs are the antithesis of "patient-centricity":


During an investor conference last week, Actavis chief executive Brent Saunders maintained that “I think we have a very good shot at it. It is not a slam dunk. But it’s a lot of hard work and there are a lot of people that have to do what they need to do. But we are very focused on it.


That is, Actavis is very focused on keeping patients on a more expensive brand-name drug than on helping patients lower or eliminate their co-pays with a generic version.


The key here is getting physicians to switch their script writing to Namenda XR because many state laws prevent pharmacists from substituting a generic for the brand name drug prescribed by the physician. Thus many pharmacists will be forced to say: "No Namenda (IR) for you!"


In any case, is this product effective in treating Alzheimer's?


More from Pharmalot: Why the Actavis Product Switching Case may Transform Pharma


“This case is huge,” says Erik Gordon, a professor at the University of Michigan Ross School of Business. If a recent court ruling is upheld, “this could signal the eventual end of the innovative pharmaceutical industry as we know it. Drug makers will have to rethink how they invest and do business.”


At the heart of the matter is a debate over reformulating a medicine and obtaining a patent to extend the product life cycle. And the case has highlighted competing notions over whether this tactic can actually create an unfair monopoly or is the correct use of intellectual property to protect profits.


It all began last year, when Forest Laboratories, which his now owned by Actavis,disclosed plans to halt sales of its twice-a-day Namenda IR tablet for Alzheimer’s. The patent expires in October and generic rivals can appear by July. The patent on a newer, once-daily Namenda XR, however, runs until 2025.


Actavis argues that Namenda XR is a better deal for patients – not only is it more convenient, but the contents of the capsule can be sprinkled on applesauce for patients who have difficulty swallowing. The drug is also sold at a slight discount, on a wholesale basis, to the older Namenda IR.


But Eric Schneiderman, the New York Attorney General, doesn’t see it this way. He argues the maneuver is “unethical and illegal,” because patients would be forced to switch to Namenda XR well before lower-cost generics are available for the older version. And so, he filed an antitrust lawsuit.


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Study: US Alzheimer's Rate Seems to Be Dropping. High School Education Helps!

Study: US Alzheimer's Rate Seems to Be Dropping. High School Education Helps! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The rate of Alzheimer's disease and other dementias is falling in the United States and some other rich countries — good news about an epidemic that is still growing simply because more people are living to an old age, new studies show.


The federally funded Framingham study tracked new dementia cases among several thousand people 60 and older in five-year periods starting in 1978, 1989, 1996 and 2006. Compared with the first period, new cases were 22 percent lower in the second one, 38 percent lower in the third and 44 percent lower in the fourth one.

The average age at which dementia was diagnosed also rose — from 80 during the first period to 85 in the last one.

During that time, there were declines in smoking, heart disease and strokes, factors linked to dementia, and a rise in the number of people using blood pressure medicines and getting a high school diploma, which reduce the likelihood of developing the condition.

"The results bring some hope that perhaps dementia cases might be preventable, or at least delayed" by improving health and education, said the study leader, Claudia Satizabal of Boston University.

Pharma Guy's insight:


If getting a high school diploma reduces the likelihood of developing Alzheimer's, then a college diploma may prevent the condition! If so, it might save Medicare a lot of money if the government paid for universal college education!

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