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News April 2012

Washington Watch

Feds Gear Up to Wage Aggressive War on Alzheimer’s as Defining Disease of Boomers and Beyond

By Alan M. Schlein

While this issue should get some bipartisan support, since Alzheimer’s doesn’t discriminate between Democrats and Republicans, the big fight will be over where the money comes to pay for increased research dollars in a fiscally-tight economy.

c_stingeralz1sAs if Obama hasn’t had enough public battles over health care reform issues, the administration is developing a national strategy to tackle what is fast becoming the defining disease of the rapidly aging baby boom generation.

The numbers tell the story. According to the Alzheimer’s Association, 1 in 8 Americans age 65 and older – more than 5 million people – now have Alzheimer’s and another 10 million baby boomers will develop it in the near future.

“There are no cures out there and there are no survivors,” says Dr. Ronald Peterson, head of the Mayo Alzheimer’s Disease Research Center, who chairs an advisory panel developing an aggressive strategy to prevent and treat Alzheimer’s effectively.

While this issue should get some bipartisan support, since Alzheimer’s doesn’t discriminate between Democrats and Republicans, the big fight will be over where the money comes from to pay for increased research dollars in a fiscally-tight economy.

The advisory panel’s goals are to slow the progression, delay the onset and ultimately prevent the now-incurable disease. The administration also wants to find a way to help millions of families and caregivers in how they deal with the disease. Administration officials concede this is an audacious task they are taking on, but they argue that the goal has to be bold because of the enormity of the problem.

Despite the fiscal restraints, experts suggest it’s time to take a new approach to Alzheimer’s disease, before the problem overwhelms the nation’s ability to deal with it. While they don’t say it directly, they suggest that until now the federal government has taken a backwards approach toward solving the Alzheimer’s problem – treatment is only started after someone already is showing signs of the disease.

The draft report of the advisory board, a group of 25 people who represent government agencies involved with Alzheimer’s as well as caregivers, care providers, state agencies, volunteer organizations, researchers and patient advocates, suggests finding a cure or a way to slow down the disease by 2025. But several advisory board members are pushing to move that date to 2020. Disease experts compare the multi-agency federal approach being planned on Alzheimer’s to the wars on heart disease and cancer.

Unless some answers are found, experts predict there will be a 50 percent increase in the number of Alzheimer’s patients over the next 20 years, to 7.7 million Americans, according to the National Institute on Aging.

Today, Alzheimer’s costs the Medicare and Medicaid programs $130 billion annually. But the disease has a much broader effect – as an estimated 15 million people are already caring for an individual with the disease.

What’s clear is that Alzheimer’s disease, is a significant factor in driving up the costs of the nation’s health care. Some experts place the estimate at more than $180 billion annually and that number is expected to skyrocket as the baby boomer generation continues to age.

What’s the Goal?

By 2050, an estimated 13 million-to 16 million Americans are projected to have Alzheimer’s, costing $1 trillion in medical and nursing home expenditures. And that doesn’t count the billions of dollars in unpaid care provided by families, relatives and friends.

Helping develop useful strategies and solutions to help families cope with the day-to-day care that is needed is one of the advisory committee’s priorities. The plan calls for increasing access to clinical trials, identifying early stages of the disease and also expanding public outreach campaigns to inform more people of what they or their friends and families will be facing in the future.

So far, the best treatments for the disease only temporarily ease some dementia symptoms. Meanwhile, a recent report found that as many as half of today’s Alzheimer’s sufferers haven’t been formally diagnosed. Such a diagnosis lets families plan ahead. But few people get examined because of the stigma attached to the disease and because many believe nothing can be done.

Congress passed the National Alzheimer’s Project Act, sponsored by Rep. Edward Markey, D-Mass., last year and President Obama signed the bill into law in January. It is coordinating a federal government response, and also, for the first time, setting time-based goals to stop Alzheimer’s or find a way to slow its progression.

The early drafts of the NAPA strategy sets four key goals:

  • Begin a national public awareness campaign of dementia’s early warning signs to improve timely diagnosis;
  • Give primary care doctors the tools to assess signs of dementia as part of Medicare’s annual check-up;
  • On the caregivers side, have caregiver’s health -- physical and mental -- regularly checked;
  • Improve the care, planning and training for families so they know what resources are available for their loved one and themselves.

One model Alzheimer’s care program, in place in New York, has already shown that caregivers who are taught how to handle common dementia problems and given proper support, allow families to keep their loved ones at home for longer.

Those programs “are dirt cheap compared to paying for nursing home care,” says David Hoffman, who oversees Alzheimer’s programs for the New York State Department of Health.

Where’s the Money?

Harry Johns, president of the Alzheimer’s Association says the research amount needs to grow to at least $2 billion. Johns, who was in charge of the strategic initiatives for the American Cancer Society before taking his current job, says, “People have different opinions about the success of the war on cancer, but people are living longer (with cancer) and have hope.”

So the fights are over how to find a medical cure and how to pay for the research. Finding a drug that slows the progress of Alzheimer’s for just five years would greatly reduce government costs and the toll on families, and Johns and others argue that Alzheimer’s is unique in that “there really isn’t another disease that has this kind of impact. It is disproportionately under-invested.”

The key question is where will the money come from, given the bad economic climate, the budget deficits, and the bitter partisan political fight over President Obama’s other health care legislation.

The National Institutes of Health oversees the bulk of groundbreaking research against diseases. But Francis Collins, director of the NIH, told USA TODAY last July that his agency’s budget was cut $321 million in the fiscal year, the second time in 40 years the NIH has had a budget that was less than the preceding year.

According to NIH, the government spend about $450 million in 2011 on research for Alzheimer’s and related dementias. By comparison, $823 million was spent on obesity, while cancers got $6 billion when you combine breast, brain and lung cancers.

With President Obama preparing to unveil his final budget proposal before the November election, the administration is planning a dramatic boost in funding for Alzheimer’s disease research. Administration officials said the proposal would add $80 million to research funding next year. The president will also call for another $26 million to help support families and others who care for Americans suffering from Alzheimer’s.

But Congress will have to approve that additional funding as part of the government’s budget. In a challenging fiscal environment, lawmakers will have to juggle among other funding priorities, the federal budget deficit and of course, a sharp partisan divide and political considerations as they face the voters for re-election in November with the lowest approval ratings in history, according to recent national polls.

 


 

SIDEBAR: The Latest Research:

Promising research advances suggest that scientists could well make substantial progress if given more funding.

Several new studies offer promising prospects. One study recently showed how a distorted protein could spread damage from one part of the brain to another in mice, opening up the possibility that a way can be found to block the spreading and prevent the dementia.

Another new study found that a drug typically used to treat skin cancer quickly reversed Alzheimer’s disease in mice, according to a study published in the journal Science.

Researchers at Case Western Reserve University gave the drug to mice that had brain hallmarks of Alzheimer’s disease: abnormal protein plaques and tangles, which destroy the brain’s centers for memory and cognitive function.

Within hours of taking the drug, called bexarotene, which was approved by the Food and Drug Administration for the treatment of skin cancer, the plaques began to clear out of the mice’s brains. After three days on the drug, more than 50 percent of the Alzheimer’s plaques had disappeared, and the mice regained some of the cognitive and memory functions typically lost by the disease’s march through the brain.

But the drug must make the leap from success in mice to success in humans, which has foiled many other promising Alzheimer’s drugs in recent years. A host of potential drugs for Alzheimer’s disease have shown promise in early research and then failed to show any actual effectiveness against the disease upon further study. Pfizer and Medivation pulled the plug on clinical trial for dimebon, an antihistamine nasal spray that had shown benefit for Alzheimer’s patients. The companies said the clinical trials failed to show that the drug actually worked against the disease.

Some in the medical community suggest that researchers must also focus on getting better at identifying Alzheimer’s disease early. Focusing on early intervention therapies has shown that through advanced brain imaging techniques and biochemical studies of cerebrospinal fluid – the water surrounding the brain – researchers can identify people who are most at risk for cognitive loss and Alzheimer’s disease before they show any outward symptoms. Until these biomarkers were discovered, the only way to identify Alzheimer’s was through an autopsy of the brain.

Guidelines for Alzheimer’s were originally published by the federal government in 1984 and only dealt with diagnosing Alzheimer’s once a person started showing signs of dementia. Since then, new discoveries have shown the disease can cause changes in the brain a decade or more before symptoms appear. So new guidelines, published recently by the National Institute on Aging and the Alzheimer’s Association, are the first to include the use of brain imaging and measurement of certain proteins in the blood and spinal fluid to spot changes that could be due to Alzheimer’s.

The new definitions of Alzheimer’s divide the disease into three stages: a phase when dementia has developed, a middle phase in which mild problems emerge, but daily functions can still be performed and the more recently-discovered phase, in which no symptoms are evident but changes are brewing in the brain.

The drive to redefine Alzheimer’s in stages is also reflected in legislation introduced in Congress that, if approved, would create specific Medicare cost codes for Alzheimer’s diagnosis, including steps involving discussions between the patient’s doctor and caregivers, a recognition that keeping family members well informed can result in better planning and care.

 

Also contributing to this column were the Associated Press, USA TODAY, Kaiser Health News, the Houston Chronicle and ABC News.

Alan Schlein has been covering the national Washington beat for Senior Wire News Service for over two decades.

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