Related Links
Alpha-1 as Seen
on PBS
Watch the PBS show about Alpha-1.
ARALAST NP AATmosphere Program
Support for Alphas and families from the ARALAST NP AATmosphere program.
News Room
GINA (Title II) Offers New Protections for Alpha-1 Patients
On November 21, 2009, Alpha-1 patients will have new protections when Title II of the Genetic Information Nondiscrimination Act (GINA) of 2008 takes effect.
GINA (Title II) focuses on protections against discrimination in employment, specifically prohibiting use of 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
Understanding GINA and these new protections is important for Alpha-1 patients and families, especially as you make decisions about family testing for Alpha-1.
Learn more about GINA from the National Human Genome Research Institute.
Request an AlphaTest® Kit.
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
May 21, 2009 is an important date for Alphas. This is the day that Title I (relating to health insurance) of the Genetic Information Nondiscrimination Act (GINA) takes effect.
What does this mean for you? It means that, effective May 21, 2009, health insurers and health plan administrators are prohibited from requesting or requiring genetic information from you or from your family members. It also means that genetic information can not be used for making decisions about insurance coverage, rates or preexisting conditions.
The GINA bill is especially significant for Alphas. Since Alpha-1 is a genetic condition, testing family members for Alpha-1 is important. With GINA, Alphas can now feel reassured that family members who may test positive will be protected.
In November, GINA (Title II) will take effect. This means Alphas will be further protected from discrimination by employers in terms of hiring, firing or promotion decisions.
Learn more about GINA from the National Human Genome Research Institute.
Advocating for Statewide COPD Plans
Illinois recently became the second state to develop a statewide COPD coalition, which focuses on encouraging more screening and funding for COPD and Alpha-1. Community leaders, advocacy groups and patients applauded the state legislature for their leadership in the fight against lung disease.
Regional Health Association of Metropolitan Chicago (RHAMC), a key Coalition member, recognized Baxter for supporting screening efforts through providing more than 50,000 Alpha-1 test kits. "Getting tested is critical to diagnosing Alpha-1, " noted Joel Africk, President and Chief Executive Officer of RHAMC.
Read more on the Alpha-1 Foundation site
Request an AlphaTest® Kit
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.
Important Risk Information for ARALAST NP
ARALAST NP is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15 mg/dL) who have known antibody against IgA, since they may experience severe reactions, including anaphylaxis.
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.
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.
ARCHIVED NEWS
Baxter Receives Approval to Process ARALAST NP Therapy
The Alpha-1 Foundation-Baxter Research Grant
ARALAST AATmosphere – Surrounding you with Alpha-1 support
Baxter receives prestigious industry award for Alpha-1 Advocacy and Disease Awareness Initiatives
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.
