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News Room
2010: Year of the Lung
The Year of the Lung is a global initiative instituted by a collaboration of the world’s leading professional respiratory organizations, including the American Thoracic Society (ATS) and the American College of Chest Physicians (ACCP).
The overall goals for 2010: Year of the Lung are
- To raise awareness about lung health among the public
- To initiate action in communities worldwide
- To advocate for resources to combat lung disease
Many programs, for physicians and patients, are planned. For example, the ACCP is hosting regional programs for primary care physicians, “COPD: What Really Works? A Best Practices Workshop for Primary Care.”
Learn about ACCP programming for 2010: Year of the Lung.
Learn about 2010: Year of the Lung
GINA (Title II) Takes Effect November 21, 2009
On November 21, 2009, Title II of the Genetic Information Nondiscrimination Act (GINA) of 2008 will take effect. Title II prohibits most employers from using genetic information for hiring, firing, and promotion decisions, and for any decisions regarding terms of employment.
Title I of GINA, which took effect on May 21, 2009, protects against discrimination in health coverage by prohibiting health insurers or health plan administrators from requesting or requiring genetic information of an individual or the individual's family members.
As you and your patients make decisions about genetic testing, it is important to understand the protections afforded by the full implementation of GINA. For more detailed information, review the Fact Sheet from the National Human Genome Research Institute of the National Institutes of Health or the FAQs from the Genetics and Public Policy Center.
University of Massachusetts Medical School Announces Gene Therapy Trial Succeeds in Boosting Protective Protein
Researchers at the University of Massachusetts Medical School and the University of Florida in Gainesville have safely given new, functional genes to patients with Alpha-1 Antitrypsin Deficiency, according to clinical findings reported in the Proceedings of the National Academy of Sciences.1 In the clinical trial, three patients who received injections of a harmless virus containing copies of a correct gene for alpha-1 protein in their upper arms were able to produce trace amounts of alpha-1 antitrypsin for up to one year.
"This trial represents a very important step toward a potential gene therapy for the 100,000 or more Americans who suffer with alpha-1 antitrypsin deficiency," said Terence R. Flotte, MD, dean of the School of Medicine and provost & executive deputy chancellor of UMass Medical School.
For further information, see the news release from University of Massachusetts Medical School
GINA (Title I) Takes Effect May 21, 2009
The Genetic Information Nondiscrimination Act (GINA) of 2008 prohibits discrimination in health coverage and employment based on genetic information. The sections of GINA which relate to health coverage (Title I) take effect beginning May 21, 2009. The sections of GINA relating to employment (Title II) will take effect on November 21, 2009.
GINA (Title I) generally prohibits health insurers or health plan administrators from requesting or requiring genetic information from an individual or an individual's family members. Using genetic information for decisions regarding coverage, rates, or preexisting conditions is also prohibited.
GINA (Title II) prohibits most employers from using genetic information for hiring, firing, or promotion decisions, and for any decisions regarding terms of employment.
For more detailed information about GINA, visit these websites:
National Human Genome Research Institute
Genetics and Public Policy Center
COPD Coalition Supports Alpha-1 Testing
Raising awareness of the need for Alpha-1 Antitrypsin Deficiency testing is one of the health issues targeted for attention by the "State Plan for Addressing COPD in Illinois." Illinois recently became the second state (after Colorado) to develop a statewide COPD coalition, focusing on strategies for reducing the burden of COPD.
Regional Health Association of Metropolitan Chicago (RHAMC), a key coalition member, recognized Baxter International Inc. for supporting screening efforts through providing more than 50,000 Alpha-1 test kits. Coalition agencies also applauded legislators for their leadership in fighting COPD.
Over 50,000 People Screened for AATD through Baxter-Sponsored Effort
Baxter International Inc. has helped screen more than 50,000 people for alpha1-antitrypsin deficiency (AATD), making it an industry leader in awareness and early diagnosis. Through the company's screening and prevalence study and provision of complimentary test kits to physicians for patient testing, more than 385 individuals have been identified since the program's inception in 2004.
"This is an important milestone in the ongoing effort to find all the AATD patients. This program has been an integral component of moving Alpha1detection forward," said D. Kyle Hogarth, MD, FCCP, University of Chicago Medical Center.
AATD is a hereditary condition that is characterized by a low level of AAT protein in the blood. This protein, which is made in the liver, helps protect lung tissue from damaging enzymes released by white blood cells. The American Lung Association estimates that there are approximately 100,000 people in the United States who have inherited AATD; up to 95 percent of them are undiagnosed. If untreated, AATD can result in early onset emphysema and premature death.
The American Thoracic Society (ATS) and European Respiratory Society (ERS) standards for the diagnosis and management of individuals with Alpha-1 Antitrypsin Deficiency recommend that all patients with chronic obstructive pulmonary disease (COPD) or asthma characterized by incompletely reversible airflow obstruction should be tested for AATD. Testing for AATD requires a simple one time blood test.
In addition to deficient patients, Baxter has also helped identify more than 5,100 carriers of AATD, or 10 percent of those tested, through this program. Carriers of AATD have a lower-than-normal serum level of AAT and phenotyping shows that they carry one altered gene. The ATS/ERS standards suggest that these individuals may be more susceptible to the damaging effects of smoking and occupational/environmental pollutants than other individuals with normal levels of AAT. This knowledge has helped physicians advise these individuals to stop smoking and implement other good health practices, including adhering to a good nutrition and exercise program and undergoing regular health exams. It also provides an opportunity for discussion of the genetics of this deficiency and to encourage patients to share this information with family members.
"AATD is one of the most common hereditary disorders in the world, yet it remains highly under diagnosed," said Shelley Shaw, Group Marketing Manager for Baxter's Pulmonology business in North America. "Baxter remains committed to helping identify undiagnosed AATD patients by providing a complimentary AlphaTest® kit. The GINA (Genetic Information Nondiscrimination Act) bill was signed into law May 21, 2008. It will go into effect May 21, 2009 and at that time patients can receive an early detection of AATD without the fear of insurance consequences. Since AATD is a genetic disease, all family members can be tested and the appropriate lifestyle changes, including the possibility of augmentation therapy to increase alpha-1 antitrypsin levels, can be made."
ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]
ARALAST NP is indicated for chronic augmentation therapy in patients having congenital deficiency of A1-PI with clinically evident emphysema. ARALAST NP is not indicated as therapy for lung disease patients in whom congenital A1-PI deficiency has not been established.
The effect of augmentation therapy with ARALAST NP on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.
Important Risk Information for ARALAST NP
ARALAST NP is contraindicated in IgA deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.
ARALAST NP is derived from pooled human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The recommended rate of administration (≤ 0.08mL/kg/min) should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactic reactions occur, the infusion should be discontinued immediately.
Safety and effectiveness in patients over age 65 years of age have not been established.
ARALAST NP should be administered at room temperature within three (3) hours after reconstitution and should be administered alone, without mixing with other agents or diluting solutions.
The safety of ARALAST NP was evaluated with ARALAST in a crossover clinical PK comparability study. The most common adverse events deemed related to ARALAST NP included headache and musculoskeletal discomfort. No serious adverse reactions or deaths were reported in the study. In the ARALAST pivotal study, the most common adverse events were headache and somnolence.
Please see ARALAST NP Prescribing Information for full prescribing details.
References
- Brantly M, Chulay J, Wang L, et al. Sustained transgene expression despite T lymphocyte responses in a clinical trial of rAAV1-AAT gene therapy. PNAS. 2009; 106:16363-16368.
