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Alzheimer's & Dementia
Pharmaceutical-Funded Coalition Says Boomers Want
Action by FDA on Alzheimer's Drugs
ACT-AD Coalition calls for recognition of
Alzheimer's as urgent national health crisis
April 27, 2006 A new coalition began an effort
today to speed up the approval of Alzheimer's treatment drugs by the
U.S. Food and Drug by releasing a survey of Baby Boomers' attitudes
about the disease. This effort by the new ACT-AD Coalition is supported by an educational grant from
two of the leading companies working to get Alzheimer's treatments
approved by the FDA Wyeth Pharmaceuticals and Elan Corporation, a
biotechnology company.
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The first goal of the ACT-AD Coalition, it says,
"is to convince the FDA to extend the same rapid approval mechanisms it
has developed for other life-threatening diseases, like cancer and
HIV-AIDS, to promising drugs for AD."
The survey of baby boomers they released supports
this goal.
"They (baby boomers) also have little confidence
that policymakers, the US healthcare system, or drug regulators are
prepared to help them. As the crisis looms, ACT-AD will press ahead for
a solution," said Daniel Perry, executive director of the Alliance for
Aging Research and chair of the new ACT-AD Coalition.
"These survey findings underscore the fact that
when Baby Boomers are asked to address the potential of Alzheimer's in
their future, they are clearly not ready emotionally, psychologically or
financially," he said.
The survey shows the majority of Boomers are
anxious about how Alzheimer's disease (AD) will affect their health and
quality of life, says the coalition's news release.
"At the same time, Boomers are frustrated that the
government and the U.S. Food and Drug Administration (FDA) do not
address adequately this looming public health crisis," it said.
The findings from the first major survey of over
1,000 American Baby Boomers about Alzheimer's disease were announced
today by the newly formed coalition of 21 advocacy groups known as
ACT-AD (Accelerate Cure/Treatments for Alzheimer's Disease), which is at
least partially funded by Elan and Wyeth.
In a news release in 2004, Elan said, "Elan and
Wyeth, solely or jointly, are the owners or exclusive licensees of more
than fifty U.S. patents and/or patent applications along with
corresponding foreign patents supporting their Alzheimer's disease
immunotherapy approach."
Perry said, "Many Boomers are currently more
focused on health issues like heart disease or arthritis and mistakenly
consider AD a problem of their elders. But when asked to consider
themselves at age 70 with Alzheimer's disease, there was a visceral
reaction and an awakening to the reality of what could await them."
"One hundred years after Bavarian physician and
researcher Alois Alzheimer first described the pathology and symptoms
that have become the hallmarks of the disease that bears his name, the
ACT-AD Coalition is launching a campaign to call attention to the
urgency of the Alzheimer's disease crisis, and, at the same time, the
lack of a well-defined approach in the U.S. for swift delivery and
access to promising transformational therapies that could halt or
reverse the disease," says the news release.
"Alzheimer's is a cruel disease that has been on
the back burner of science for 100 years but no one is immune to it and
the toll will be staggering unless Baby Boomers wake up to the threat
and do something about it," said Meryl Comer, Emmy Award-winning
television journalist and full-time caregiver for her husband who was
diagnosed with AD over 11 years ago at age 58.
"When the onset of the disease is early for a loved
one, it is like being a witness to your own future and I am terrified
for us all," she added.
Survey Findings
The web-based survey was conducted by Opinion
Research Corporation for ACT-AD and sampled 1,009 Americans born between
1946 and 1964. All data were weighted to represent the US general
population with respect to age, gender and geographic region. The
maximum error range for a sample of 1,000 is +/-3.1 percentage points at
a 95 percent confidence level.
In summary, survey results reveal that when
provided with basic information on Alzheimer's disease, the vast
majority of Baby Boomers are extremely concerned about the potential
impact on their health, quality of life and finances as well as on the
healthcare system.
Boomers express clear and significant concerns with
current treatment options as well as the level of response from the
government and the FDA. They place top priority on new drugs that could
change the course of the disease, feel that the FDA should give priority
review to these drugs, expect the right to decide whether to use them,
and are willing to accept a degree of risk with promising drugs.
Key Findings include:
● Personal Preparedness for Alzheimer's -- 90
to 95 percent of respondents said that they would either be unprepared
or would find life "not worth living" if they were forced to face
limitations common to the disease by the time they were 70. These
limitations included basic abilities (not being able to dress or toilet
themselves), social interactions (not being able to recognize family
members) and mental abilities (not being able to remember who or where
they are).
● Cost of Alzheimer's -- 80 percent of
respondents said that their current savings would not be sufficient to
cover the cost of care if they were diagnosed and 81 percent said the
same thing about their families' savings. 83 percent said they are also
worried that the healthcare system is under-prepared to cover the
demands of the coming Alzheimer's crisis.
● Treatment Options -- Only 8 percent of
respondents feel that current treatments are adequate. In fact, most
(80 percent) are willing to take experimental treatments that have the
potential for stopping the disease and preserving their quality of life,
even if significant health risk was involved. Respondents put the
highest priority on drugs that stop the disease/loss of mental abilities
(84 percent) or that reverse the disease/loss of mental abilities (82
percent), even though current drugs do none of these things. 90 percent
of respondents felt that drugs that have this potential should be given
the same priority review and fast track status that the FDA gives to
drugs for other life-threatening diseases as cancer and HIV/AIDS.
● Satisfaction with Government/FDA -- When
provided with an overview of the FDA's current review policy for
Alzheimer's drugs, 82 percent of respondents remained unsure about what
the government is doing to prioritize Alzheimer's, but most (84 percent)
feel that more should be done and over 75 percent feel that Alzheimer's
should be made a top priority. 89 percent feel that promising
Alzheimer's drugs deserve the same priority status and fast track review
that the FDA uses for drugs for other serious diseases.
"What is most striking about these findings is that
Americans are no longer accepting the longstanding myth that real
treatment breakthroughs for Alzheimer's are still decades off,"
commented Samuel Gandy, MD, director of the Farber Institute for
Neurosciences at Thomas Jefferson University. "The reality is that
decades of research have given us a number of investigational and highly
promising drugs that could slow or even prevent Alzheimer's. Everyone
involved in the discovery, development and approval of these drugs
should act with urgency and resolve."
Coalition Says It Declares War on Alzheimer's
As the FDA continues to pursue its Critical Path to
modernize the scientific process for developing and evaluating medical
products, ACT-AD will begin a comprehensive campaign to work with the
agency and legislators involved in health policy to elevate AD as a
national health priority.
These initial steps are part of ACT-AD's blueprint
for changing the Nation's overall response to the coming Alzheimer's
crisis. Planned Coalition initiatives include:
● Partnering with the FDA to identify barriers,
evaluate and recommend processes and systems, and create actionable
plans to expedite reviews of transformational Alzheimer's therapies
● Meeting with key congressional leaders
involved in health policy reform and regulatory reform to assure that
promising treatments reach Alzheimer's patients quickly
● Facilitating collaboration among leading
research institutions to adopt new strategies to bridge the gap between
basic research and clinical research in order to promote innovation
while expediting development of transformational therapies
● Educating the public through coalition
membership initiatives
● Mobilizing the public to make their voices
heard by congressional representatives
● Recruiting corporate America to push for new
strategies to address Alzheimer's disease as it will have an impact on
employee productivity and spiraling health care costs
● Informing the media in order to focus
national attention on the need for a new Alzheimer's disease strategy
"Right now the majority of Alzheimer's victims and
their caregivers are our parents. Their plight is our future. We are
ticking time bombs without even knowing it," said Meryl Comer, who
recently published "From the bedside: A terrified witness to the future
-- A baby boom generation wake-up call," in the April issue of the
scientific journal, Alzheimer's & Dementia.
"My hope is that ACT-AD will help in the push to
get promising AD drugs to patients. As families, we are desperately in
need of access to new therapies instead of being left with only
agonizing decisions. It is time to borrow a page from HIV activists of
the '80s and breast cancer survivors of the '90s.
"We need to make it clear, as a generation of 75
million strong, that this kind of outcomes to our lives is unacceptable
and that we refuse to be robbed of our minds without a fight."
ACT-AD Background
ACT-AD is a growing coalition of organizations representing patients,
caregivers, consumers, older Americans, researchers, and women's health
advocates. The Coalition, comprised of 21 organizations, is directed by
an Advisory Council including the following members: The Alliance for
Aging Research, The Alzheimer's Foundation of America, The American
Society on Aging, The National Association of Area Agencies on Aging,
National Alliance for Caregiving, the National Consumers League,
Research!America, and The Society for Women's Health Research. Other
members include: The Abigail Alliance, The American Association for
Geriatric Psychiatry, The American Medical Women's Association, Faster
Cures, The Gerontological Society of America, Hadassah, The
International Eye Foundation, The Institute for the Study of Aging, The
Men's Health Network, The National Council of Patient Information and
Education, The American Federation for Aging Research, International
Longevity Center and The Older Women's League. The Coalition is
supported through an educational grant by Elan and Wyeth.
About Elan and Wyeth
These two companies work closely together in the development of
Alzheimer's drug treatments. Elan and Wyeth brought together academic
and industry experts from around the world last year to present a
comprehensive overview of immunotherapy-related research in Alzheimer's
disease.
In a news release in 2004, Elan said, "In 2000,
Elan and Wyeth formed a collaboration to discover, develop and
commercialize immunotherapeutic approaches to prevent and treat
Alzheimer's disease. The companies are currently pursuing beta amyloid
immunotherapy for mild to moderate Alzheimer's disease in a Phase I
safety study of a humanized monoclonal antibody, AAB-001. Elan and Wyeth
are also developing ACC-001, a novel beta amyloid-related active
immunization approach that is in the late preclinical discovery phase."
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company that
is focused on discovering, developing, manufacturing and marketing
advanced therapies in neurology, autoimmune diseases, and severe pain.
Elan (NYSE: ELN) shares trade on the New York, London and Dublin Stock
Exchanges.
About Wyeth
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), has leading
products in the areas of women's health care, cardiovascular disease,
central nervous system, inflammation, transplantation, hemophilia,
oncology, vaccines and nutritional products. Wyeth is one of the world's
largest research-driven pharmaceutical and health care products
companies. It is a leader in the discovery, development, manufacturing,
and marketing of pharmaceuticals, vaccines, biotechnology products and
nonprescription medicines that improve the quality of life for people
worldwide. The Company's major divisions include Wyeth Pharmaceuticals,
Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
For more information about the ACT-AD Coalition and
campaign against Alzheimer's disease, visit
http://www.act-ad.org/.
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