Conference To Share Cutting Edge Developments In Dementia Research

With more than 35 million people worldwide living with Alzheimer’s disease or a related dementia, the search for answers has never been more critical.

With this in mind, the very best minds in dementia research and care, both in Canada and abroad, will converge on Toronto today at the 5th Canadian Conference on Dementia to share the very latest developments in the field.

“Dementia is a rapidly growing issue for Canadians, an issue that needs immediate attention if we are to mitigate the impact of this illness on our health and social systems,” says Dr. Ron Keren, Conference Chair. “The Canadian Conference on Dementia is an opportunity for the international community of experts to come together and share critical information on the latest in research and care.”

The conference will open with two keynote presentations by Dr. Margaret Lock (McGill University) and Dr. Mary Ganguli (University of Pittsburgh), followed by the presentation of I’m Still Here, a powerful research-based play illustrating the perspective of persons living with dementia and their family partners in care.

The conference will also feature sessions on risk factors, diagnosis, treatments, quality of life, caregiving and the need for a national dementia strategy. This diverse program will explore the challenges of dementia, address the issues facing people with the illness, and present ways to help change the future of the disease.

The Canadian Conference on Dementia will take place October 1 to 3 at the Westin Harbor Castle Hotel in Toronto. To see the full schedule of speakers and topics, please visit ccd2009.

Canadian Conference on Dementia

The Canadian Conference on Dementia is a biannual national conference on dementia that is sponsored by the Canadian Geriatrics Society, the Canadian Academy of Geriatric Psychiatry, the Canadian Neurological Society, the Consortium of Canadian Centres for Clinical Cognitive Research, the Canadian Institutes of Health Research-Institute of Aging, the Canadian Dementia Knowledge Translation Network and the Alzheimer Society of Canada.

Alzheimer’s Society

Cells That Control Inflammation In Chronic Disease

A new type of immune cell that can be out of control in certain chronic inflammatory diseases, worsening the symptoms of conditions like psoriasis and asthma, is described for the first time this week in the Journal of Clinical Investigation.

The authors of the study, from Imperial College London, the Istituto Dermopatico dell’Immacolata in Rome and the Center of Allergy and Environment (ZAUM) in Munich, hope their discovery could lead to new treatments for these diseases that would bring the cells under control.

The new cell described in the study, called a Th22 cell, is a kind of T-helper cell. These cells are white blood cells that help to activate other immune cells when the body is infected by a pathogen, such as a virus or bacterium. They also control inflammation in the body to help fight off infection.

According to the new study, Th22 cells play a special role in overseeing and coordinating immune cells that cause inflammation. In chronic and allergic inflammatory diseases like psoriasis and allergic eczema, Th22 cells appear to be malfunctioning, leading to excessive inflammation, which can worsen symptoms.

The researchers hope that it may ultimately be possible to treat chronic skin and possibly also airway diseases by targeting Th22 cells with new drugs.

Dr Carsten Schmidt-Weber, one of the lead authors of the study from the National Heart and Lung Institute at Imperial College London, said: “We are seeing an increase in chronic diseases like skin and airway disease because of changes in people’s lifestyles. These diseases can have a big impact on people’s lives and patients can face a constant battle to keep their symptoms at bay. We are very excited about discovering this new subset of T-helper cells, as we believe it could provide a new target for the treatment of chronic inflammatory diseases in the future.”

The researchers discovered Th22 cells by looking at skin samples from people with psoriasis, atopic eczema and allergic contact dermatitis. They analysed the samples and found a completely new type of cell. The researchers examined the molecules the cells made and found that one of them was a signalling molecule called interleukin-22 (IL-22). This signalling molecule warns tissues that inflammation or infection is going to occur, so the tissues can get ready to recognise and attack pathogens or protect themselves against inflammation. The effect of this can be either protective or detrimental – for example, IL-22 molecules and Th22 cells can cause skin cells to grow too quickly, resulting in painful, flaking skin.

The authors of the new study hope that their new discovery will provide scientists developing treatments for inflammatory disorders with a new cellular drug target. The researchers are now investigating the role of these cells in greater detail and exploring their role in disease progression. In addition, Dr Schmidt-Weber and his colleagues want to know how the cells are generated in the body and whether there is any way to control these cells before they cause unwanted damage.

Source: Lucy Goodchild

Imperial College London

Newly Discovered Protein May Help Explain Tuberculosis’ Resiliency – Experts Find Another Reason Why The Bacterium Is So Nasty

Weill Cornell scientists have located a protein produced by the tuberculosis bacterium that may tell researchers more about how the invader lives so resiliently inside of the body. Dr. Benjamin Gold, working with Dr. Carl Nathan, chairman of microbiology and immunology at Weill Cornell Medical College and their colleagues, located a protein called mycobacterial metallothionein (MymT), which acts like a shield to protect the tuberculosis bacterium from the body’s natural defenses.

The tuberculosis bacterium lurks within cells called macrophages — immune system cells that bombard harmful microbes with a soup of chemicals, including nitric oxide. The researchers believe that the newly discovered protein helps the bacterium resist a newly discovered action of nitric oxide, thus allowing the infection to stay strong within the body. The Weill Cornell scientists discovered nitric oxide can liberate copper from proteins within the bacterium, and may also reduce it from a relatively harmless form to lethal form. The new protein, MymT, binds the copper to protect the bacterium from being poisoned by the metal.

All the genetic information in the tuberculosis organism was sequenced in 1998. Yet the gene encoding MymT was overlooked until now because of its very small size and the novel way it encodes the protein. Thus, this study suggests that there may be other genes in bacterial pathogens that contribute to their potential to cause disease, but which have otherwise been overlooked, including relatives of MymT.

The study is published in a recent issue of the journal Nature Chemical Biology.

Weill Cornell Science Briefs

Weill Cornell Science Briefs is an electronic newsletter published by the Office of Public Affairs that focuses on innovative medical research and patient care at Weill Cornell Medical College and NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The newsletter is sent electronically to journalists and available to all on this Web site. To read Science Briefs on the Web, please visit: medrnell/science.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances — from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson’s disease, the first indication of bone marrow’s critical role in tumor growth, and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient. NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children’s Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree oversees and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit nyp and medrnell.

Weill Cornell Medical Center
NewYork-Presbyterian Hospital

Efforts To Combat Malaria Taking Off

Nothing But Nets announced that the
campaign’s efforts to fight malaria by delivering long-lasting,
insecticide- treated nets (bed nets) to children and families throughout
Africa were highlighted at today’s White House Summit on Malaria hosted by
President George Bush and First Lady Laura Bush.

Since May 2006, the Nothing But Nets campaign has raised over $1.7
million with average donations of 62 dollars. Representatives from the
founding partners of the campaign, The National Basketball Association, the
People of the United Methodist Church and the United Nations Foundation
were all present at this historic event showcasing private and public
efforts to eradicate malaria.

“While bed nets are just one way to curb the spread of malaria, the
power of the campaign is that it is an easy thing for people to understand
and even easier for them to have an impact, ” said Kathy Behrens, Senior
Vice President for Community and Player Programs. “Send a net. Save a life.
It’s just that easy.”

Through NBA Cares, the NBA and WNBA, its teams and players have taken a
holistic approach to supporting the Nothing But Nets campaign — committing
to implementing grassroots events & activities; engaging in communication
and awareness efforts; helping generate funds; and participating in bed net
distributions. On January 23rd, 2007, NBA Legend Sam Perkins will be in
Lagos, Nigeria to participate in the distribution of bed nets with the
Measles Initiative through the World Health Organization.

The People of the United Methodist Church have been in mission across
Africa for more than 160 years. The denomination’s work in the area of
malaria prevention makes it a natural partner for Nothing but Nets. Several
global agencies of The United Methodist Church will launch supporting
campaigns to educate and raise money for bed nets.

“Ending malaria is going to take the power of millions of people,” said
Thomas Bickerton, a Bishop in The United Methodist Church in the USA.
“Working with all of the partners, we’re hoping to inspire the global
community to help us end this disease by providing bed nets to women and
children all across Africa.”

Nothing But Nets was created by the UN Foundation in May 2006. Inspired
by a column Sports Illustrated’s Rick Reilly, the campaign’s
founding partners are the National Basketball Association’s NBA Cares, The
People of the United Methodist Church, and Sports Illustrated. Other
partners include AOL Black Voices, Malaria No More, Rotarians’ Action Group
on Malaria and VH- 1.

Bed net distributions are organized and implemented by the Measles
Initiative. Measles Initiative partners include the American Red Cross,
United Nations Foundation, Centers for Disease Control, World Health
Organization, and UNICEF.

In October 2006, representatives of the campaign traveled to Nigeria to
visit with families who had received the first shipment of more than
150,000 long-lasting insecticide-treated nets. The nets sent to Nigeria
were the first of many that will be shipped to Africa through Nothing But

While malaria has largely been eradicated in the United States, nearly
500 million people are still infected each year, mostly in Africa. More
than one million of those infected died from the disease. Seventy-five
percent of those deaths are children under five-years old. Every day 25
million pregnant women risk severe illness and harm to their unborn
children from a malaria infection.

The most cost-effective and simple approach to combat malaria is
through the use of insecticide- treated bed nets, which can prevent malaria
transmission by 50 percent. It costs $10 to buy and distribute a bed net
and to educate others on its use. Despite the effectiveness of preventing
transmission, according to the 2005 World Health Organization’s World
Malaria Report, only three percent of children under five in Africa sleep
under a bed net.

About Nothing But Nets

Nothing But Nets is a global, grassroots campaign to save lives by
preventing malaria, a leading killer of children in Africa. Inspired by
Sports Illustrated columnist Rick Reilly, thousands of people have joined
the campaign that was created by the UN Foundation. Founding campaign
partners include the National Basketball Association’s NBA Cares, The
People of the United Methodist Church, Malaria No More, and Sports
Illustrated. Other partners include VH-1, AOL Black Voices, and Rotarians’
Action Group on Malaria. It only costs $10 to provide an
insecticide-treated bed net that can prevent this deadly disease. Visit
NothingButNets to send a net and save a life.

Nothing But Nets

NOVAVAX Completes Enrollment In Phase IIa Study Of Seasonal Influenza Vaccine In Older Adults

Novavax, Inc. (Nasdaq: NVAX) announced it has completed enrollment in the Phase II clinical study of its trivalent seasonal influenza (2008/2009 recommended strains) VLP vaccine candidate in healthy adults 60 years of age or older (older adults). This randomized, double-blind, active-controlled study is comparing the safety, tolerability and immunogenicity of two different doses (15 mcg and 60 mcg) of Novavax’s trivalent seasonal influenza VLP vaccine to a commercially available trivalent inactivated vaccine, TIV (Fluzone®).

This study enrolled 467 older adults in a three-arm study at six different sites located within the United States. In addition to evaluating hemagglutinin inhibition (HAI) responses, anti-neuraminidase and cell-mediated immune responses are also being examined. Previous studies have shown that VLP-based flu vaccines drive strong neuraminidase inhibition (NAI) antibody titers and T-cell responses, indicating the potential for broader immunologic responses particularly in older adults.

“With the rapid completion of enrollment in this clinical trial as well as the first part of our H1N1 vaccine study in Mexico announced previously, we are on track to report results from our two most advanced clinical programs during the first quarter of next year,” said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. “If results from the seasonal flu vaccine study are positive, we will be able to advance this program into Phase III clinical testing as early as 2010.”

Seasonal Influenza

Seasonal influenza infects between 5 percent and 20 percent of the world’s population and kills between 250,000 and 500,000 people each year. In the United States, the Centers for Disease Control and Prevention estimates that 15 to 60 million people contract influenza each year leading to over 200,000 hospitalizations and 36,000 deaths. The Advisory Committee on Immunization Practices (ACIP) currently recommends seasonal influenza vaccination for children six months through 18 years of age, pregnant women, and adults over 50 years of age, and individuals of any age with chronic health conditions or who are at high risk of influenza disease. Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013.

About VLPs

Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax’s VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.

About Novavax

Novavax, Inc. is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India.

Forward Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical trials and development of the seasonal influenza vaccine and other anticipated milestones are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including clinical trial results, which may not be sufficient for regulatory approval or may indicate safety concerns not yet encountered; even if the results of the planned clinical trials are positive, the data may not be accepted by regulatory bodies or the seasonal influenza vaccine may not be approved by the United States government or additional clinical trials may be required; the Company has not yet manufactured, or relied on third parties to manufacture, any vaccines at a commercial scale; competition from already approved vaccines for seasonal influenza; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; the Company’s ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the Company’s ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration; the cost, timing and success of regulatory filings and approvals; the Company’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. Further information on the factors and risks that could affect Novavax’s business, financial conditions and results of operations, is contained in Novavax’s filings with the U.S. Securities and Exchange Commission, which are available at sec. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

Source: Novavax, Inc

View drug information on Fluzone Preservative-free.

Dieting and exercise improve osteoarthritis

A combination of weight loss and exercise provides functional improvements in overweight patients with osteoarthritis, a new study shows.

Research published in Arthritis and Rheumatism involved 316 older adults with knee osteoarthritis and a BMI of at least 28 who were randomized to receive a dietary intervention, an exercise intervention, both, or usual care. Of these subjects, 252 completed the study.

The exercise programme involved thrice weekly hour-long sessions that focused on aerobics and resistance training.

The dietary intervention incorporated group dynamics theory and social cognitive theory into a staged program with a goal of maintaining an average weight loss of 5% during the 18-month period.

Subjects in the diet-plus-exercise group experienced a significant improvement in self-reported physical function, 6-minute walk distance, stair-climb time, and knee pain.

The diet-only intervention appeared to offer no functional benefits over usual care but patients in the dietary intervention groups lost significantly more weight than those in the usual care group.

“The results of the study are important for clinicians and patients, because they provide evidence for significant, although modest, treatment effects of a dietary weight loss programme combined with regular exercise classes for sedentary, overweight and obese individuals with knee osteoarthritis,” Dr. Marlene Fransen, from the University of Sydney in New South Wales, Australia, notes in a related editorial.

Reference: Messier S et al (2004) Exercise and dietary weight loss in overweight and obese older adults with knee osteoarthritis: The arthritis, diet, and activity promotion trial Arthritis Rheum 50 (5) 1501-1510

From: Nursing Times Online

Turning The Tide Of Dementia, Hope Is In Prevention, Research

With the prevalence of dementia expected to reach 1.1 million Canadians within a generation, taking care of your brain health has never been more important.

This Brain Awareness Week, March 15 to 21, the Alzheimer Society is calling on Canadians coast to coast to take action today. This means doing everything you can to reduce your risk of developing dementia, including adopting a healthy lifestyle through diet and exercise, staying mentally and socially active , and protecting your head from injury.

“If nothing changes, by 2038 there will be a new case of dementia in Canada every two minutes,” says Dr. Jack Diamond, Scientific Director for the Alzheimer Society of Canada. “We may not be able to control all the risk factors, but more and more, research is telling us that a healthy diet, modest exercise, and ongoing mental stimulation, can provide significant protection for our brains, and reduce the risk of developing dementia.”

According to the Alzheimer Society’s new study, Rising Tide: The Impact of Dementia on Canadian Society, risk reduction is also key to lessening the social and economic impacts of dementia.

“The research in Rising Tide tells us that exercise, along with other risk reduction strategies, is one of the most promising ways to reduce the massive $872 billion dementia is expected to cost Canadians over the next 30 years,” says Kelly Duffin, CEO of the Alzheimer Society of Canada.

A further investment into research is also critical if we are to turn the tide of dementia. This includes research into learning more about the benefits of prevention as well as to find more effective treatments and eventually a cure.

This Brain Awareness Week – the Alzheimer Society invites media to interview leading dementia experts in the field of prevention and risk reduction to help Canadians learn about achieving good brain health. For more information, please contact Patricia Wilkinson at 416-669-5715.

About Brain Awareness Week

Brain Awareness Week is an international campaign, coordinated by the Dana Alliance for Brain Initiatives, to increase public awareness of the progress and benefits of brain research. Brain Awareness Week is a unique international partnership of more than 2,100 organizations in 69 countries, and is celebrating its 15th anniversary campaign in 2010.

Alzheimer Society

Bungee-Powered Backpack Can Reduce Strain on Back

Old Saint Nick might very well be able to run from rooftop to rooftop without reindeer this year, if only he carried toys in a backpack like the one developed by biologists at the University of Pennsylvania.

In this week’s edition of the journal Nature, Penn researchers have announced details for a suspended-load ergonomic backpack that reduces the force of a backpack’s load on the wearer by 86%, allowing wearers to run far more comfortably with heavy loads.

While it might be useful for Santa, the backpack was created with soldiers and emergency workers in mind and could prevent the sort of muscle and joint injuries associated with running while carrying heavy items. The Penn researchers also point out that the backpack will also benefit schoolchildren, since heavy book bags have been linked to muscle and orthopedic injury.

“For the same energetic cost, you can either carry 48 pounds in a normal backpack or 60 pounds in a suspended-load ergonomic backpack,” Larry Rome, a professor in Penn’s Department of Biology, said. “It is like carrying an extra 12 pounds for ???free.’”

The backpack is based on a rigid frame pack, much like the type familiar to hikers everywhere; however, rather than being rigidly attached to the frame, the sack carrying the load is suspended from the frame by bungee cords.

Last year, Rome, an expert in the physics of muscle movement, introduced a power-generating backpack that converts mechanical energy from walking into as much as 7.4 watts of electricity, more than enough energy to power a number of portable electronic devices at once. His findings were published in Science.

The suspended-load ergonomic backpack has a similar sliding motion as the electricity generating-backpack, but it is tuned differently. Rather than having stiff springs, the load is suspended by very compliant bungee cords.

“The ergonomic backpack reduces the force of the load on the wearer by reducing the effect of the load as it shifts up and down,” Rome said. “What is striking is that you can feel the 86% reduction in force with every step.”

With a normal backpack, the peak force exerted by the load on the body during walking is twice as high as the static force, and during running it’s three times as large, exerting extreme forces on the joints.

The backpack shifts the timing of how force is applied as the wearer takes a step.

“Essentially, the bungee cords permit the load to stay at nearly constant height from the ground while the wearer walks or runs around it,” Rome said. “The pack actually reduces the metabolic cost of walking from one point to another by about 40 watts, or the equivalent of carrying 12 extra pounds.

Penn researchers involved in development and testing of the Suspended-load Backpack at the Rome laboratory at Penn are Louis Flynn, an engineer, and postdoctoral fellow Taeseung D. Yoo. Funding for this research comes from the National Institutes of Health and the Office of Naval Research.

Contact: Greg Lester

University of Pennsylvania

New “Generation Alzheimer’s” Report Calls Alzheimer’s Defining Disease Of The Baby Boomers

Starting this year, more than 10,000 baby boomers a day will turn 65. As these baby boomers age, one of out of eight of them will develop Alzheimer’s – a devastating, costly, heartbreaking disease. Increasingly for these Baby Boomers, it will no longer be their grandparents and parents who have Alzheimer’s – it will be them.

“Alzheimer’s is a tragic epidemic that has no survivors. Not a single one,” said Harry Johns, president and CEO of the Alzheimer’s Association. “It is as much a thief as a killer. Alzheimer’s will darken the long-awaited retirement years of the one out of eight baby boomers who will develop it. Those who will care for these loved ones will witness, day by day, the progressive and relentless realities of this fatal disease. But we can still change that if we act now.”

According to the new Alzheimer’s Association report, Generation Alzheimer’s, it is expected that 10 million baby boomers will either die with or from Alzheimer’s, the only one of the top 10 causes of death in America without a way to prevent, cure or even slow its progression. But, while Alzheimer’s kills, it does so only after taking everything away, slowly stripping an individual’s autonomy and independence. Even beyond the cruel impact Alzheimer’s has on the individuals with the disease, Generation Alzheimer’s also details the negative cascading effects the disease places on millions of caregivers. Caregivers and families go through the agony of losing a loved one twice: first to the ravaging effects of the disease and then, ultimately, to actual death.

“Most people survive an average of four to six years after a diagnosis of Alzheimer’s disease, but many can live as long as 20 years with the disease. As the disease progresses, the person with dementia requires more and more assistance with everyday tasks like bathing, dressing, eating and household activities,” said Beth Kallmyer, senior director of constituent relations for the Alzheimer’s Association. “This long duration often places increasingly intensive care demands on 11 million family members and friends who provide unpaid care, and it negatively affects their health, employment, income and financial security.”

The report also offers very personal glimpses into the lives of families who are in the throes of caring for a loved one with Alzheimer’s disease, including a son who struggles to change the diapers of the mother who changed his as an infant, and a husband who watches his wife’s fascination with the “lady in the mirror,” not realizing the lady in the mirror is her.

In addition to the human toll, over the next 40 years Alzheimer’s will cost the nation $20 trillion, enough to pay off the national debt and still send a $20,000 check to every man, woman and
child in America. And while every 70 seconds someone in America develops Alzheimer’s disease today, by 2050 someone will develop the disease every 33 seconds – unless the federal government commits to changing the Alzheimer trajectory.

“Alzheimer’s – with its broad ranging impact on individuals, families, Medicare and Medicaid – has the power to bring the country to its financial knees,” said Robert J. Egge, vice president of public policy of the Alzheimer’s Association. “But when the federal government has been focused, committed and willing to put the necessary resources to work to confront a disease that poses a real public health threat to the nation – there has been great success. In order to see the day where Alzheimer’s is no longer a death sentence, we need to see that type of commitment with Alzheimer’s.”

The full text of the Alzheimer’s Association’s Generation Alzheimer’s report can be viewed here.


Alzheimer’s Association

FDA Regulations On Ozone Depleting Drugs Will Impact Availability Of Combivent

The Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have jurisdiction over lessening the use of ozone-depleting substances (ODS) in pressurized containers called chlorofluorocarbon (CFC) propellants. The Montreal Protocol and the Clean Air Act aim to transition away from all CFC containing products because of public health concerns.

The FDA is reviewing the “essential use” designation for seven Metered Dose Inhaler (MDI) drugs which they suggest should be phased out by December of 2009. One of the medications is recommended for removal from the essential list is Combivent. There is no equivalent substitute for Combivent at this time (but there should be by 2010, but not 2009 ).

By removing Combivent from the essential use designation, approximately 2,000,000 COPD patients would be forced to obtain drugs in two separate prescriptions, and perhaps make two co-payments to purchase, and use, two different delivery devices containing one medication each to achieve the same clinical result as with Combivent.

The AARC supports the provisions of the Montreal Protocols and the Clean Air Act, and we support the phase out of ozone depleting drugs, but only when there is a true substitute that will not impact the patient. The AARC submitted comments to the FDA on this issue.

American Association for Respiratory Care