February 9 , 2009
Volume VI, No. 22
Register Now for the ISVMA Spring Seminar Series
ISVMA is excited to announce the 2009 Spring Seminar Series! This is the first license renewal cycle in which veterinarians must obtain 40 hours of CE and veterinary technicians must obtain 15 hours. Therefore, we have expanded our program and we are offering concurrent sessions for veterinary practice owners/managers and veterinary technicians/assistants.
Full program information (including course descriptions, speaker bios, directions and schedule) is available on the ISVMA website.
Registration is open and limited for each venue. Please register early!
The practice owner/manager program is called, "Hard Times Management: Improving Your Hospital in a Recessionary Time." The presenters include Christine A. Merle, DVM, CPA, CVPM; Judy Jennings, MBA; and a representative from a top accounting firm.
The veterinary technician/assistant program will be presented by Mr. Angel Rivera CVT, VTS (ECC). He will speak on a number of topics including: Veterinary Nursing: Ethics and Professionalism; 20 essential tools of monitoring, diagnostics and assessments to use in the critically ill ICU patient; Basic Patient Parameter Assessment (Triage); and How to become an indispensable part of a winning team and increase practice profitability through the appropriate use of staff.
The 2009 ISVMA Spring Seminars will be offered at three locations:
The ISVMA Spring Seminar Series programs will run from 9:00 a.m. until 3:30 p.m. and qualify for 6 hours of continuing education credit.
The ISVMA wishes to thank the sponsors of the 2009 ISVMA Spring Seminar Series:
FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder
The U.S. Food and Drug Administration today issued its first approval for a biological product produced by genetically engineered (GE) animals.
The approval is for ATryn, an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin (AT) deficiency. These patients are at high risk of blood clots during medical interventions, such as surgery, and before, during and after childbirth.
ATryn is a therapeutic protein derived from the milk of goats that have been genetically engineered by introducing a segment of DNA into their genes (called a recombinant DNA or rDNA construct) with instructions for the goat to produce human antithrombin in its milk. Antithrombin is a protein that naturally occurs in healthy individual and helps to keep blood from clotting in the veins and arteries.
GTC Biotherapeutics, Inc., the manufacturer of ATryn, received approvals from two FDA centers. The Center for Biologics Evaluation and Research (CBER) approved the human biologic based on its safety and efficacy, and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the goats that produce ATryn.
"This product offers an important new treatment option for patients with hereditary antithrombin deficiency, preventing life-threatening clots that otherwise frequently occur during high risk situations," said Jesse Goodman, M.D., M.P.H., CBER director.
Because hereditary AT deficiency occurs in a small population (approximately 1 in 5,000 people in the United States), the FDA granted ATryn an orphan drug designation. The orphan drug designation system encourages the development of medications for patients with a rare disease or condition.
The agency held an advisory committee meeting in January to seek the opinion of outside experts, who agreed that ATryn is safe and effective. CVM also briefed the committee about the animal drug components of the application.
Hereditary AT deficiency generally is first recognized and diagnosed in teenagers or young adults when they develop clots in their blood vessels, particularly during pregnancy, surgery, or prolonged bed rest.
CBER evaluated two studies that included 31 patients with hereditary AT deficiency who received ATryn to prevent thromboemboli (TE) before, during or after surgery or childbirth. All but one patient had a prior history of at least one TE, which are likely to recur in high-risk situations if left untreated. Only one of the 31 patients treated with ATryn developed a TE. The most common adverse reactions reported were hemorrhage and reactions at the infusion site. These reactions occurred in approximately five percent of patients.
As part of its review of the GE goat, CVM assessed the safety of the rDNA construct to the animals, including a full review of the construct and its stability in the genome of the goats over seven generations. No adverse outcomes were noted. CVM reviewed and concurred with the sponsor's plan to continue to monitor the construct and its expression for the lifetime of the approved product.
During its review, CVM determined that introduction of the rDNA construct did not cause any adverse outcomes to the health of the goats over seven generations. CVM also determined that the manufacturer, GTC, has adequate procedures in place to ensure that food from these goats does not enter the food supply. As part of the approval, CVM specified that these goats cannot be used for food or feed and validated a method suitable for identifying the rDNA construct in both animals and their products.
As required by the National Environmental Policy Act and its implementing regulations, CVM also determined that the GE goats do not cause any significant impact on the environment.
“We have looked carefully at seven generations of these GE goats; all of them are healthy and we haven't seen any adverse effects from the rDNA construct or its expression. I am pleased that this approval makes possible another source of an important human medication,” said Bernadette Dunham, D.V.M., Ph.D., CVM director.
A summary of the information on which the FDA made its approval decision for the rDNA construct in the goats, and CVM's guidance on the regulation of GE animals containing heritable rDNA constructs are available at http://www.fda.gov/cvm/GEAnimals.htm.
ATryn previously received approval from the European Medicines Agency for use in preventing clotting conditions during surgical procedures in patients with hereditary AT deficiency.
ATryn is manufactured by GTC Biotherapeutics, Inc., Framingham, Mass.
ISVMA Grassroots Impact
ISVMA sent four legislative alerts to members with email addresses on Saturday afternoon. The alerts asked ISVMA members to contact their legislators on the following issues:
The membership response to the calls to action has been very strong. In the first 48 hours since the alerts were sent, 117 of the 177 members of the Illinois General Assembly have been contacted by at least one ISVMA member. ISVMA has been contacted by legislators thanking us for getting them information to help them understand the issues.
Keep up the good work and, if you haven't responded to the alerts yet, you can do so by clicking on the links to the four bills above or reviewing all of the Action Alerts at http://capwiz.com/isvma/home/.
Update on New Legislative Issues
It looks like this is going to be a very busy legislative session. I n addition to the bills listed above, the ISVMA is in the process of introducing bills on the following:
Since the last E-SOURCE Newsletter, other bills have been introduced on topics including:
ISVMA is analyzing the above bills and will be drafting position statements on these and other issues on which we take formal positions.
If you would like to participate and help ISVMA with its legislative agenda, you can see a list of current Action Alerts, bills we are working on and our position statements at http://capwiz.com/isvma/home/. Please feel free to download and distribute our position papers.
About the Photo
Have you seen your first American Robin of the spring? Did you know that it might have been in Illinois all winter? Although the appearance of a robin is commonly considered a harbinger of spring, the American Robin actually spends the winter in much of its breeding range (including Illinois). However, because they spend less time in yards and congregate in large flocks during winter, you're much less likely to see them. The number of robins present in the northern parts of Illinois varies each year with the local weather conditions.
Although the American Robin is at home breeding in deep, mature forests, it is the most widespread thrush species in North American backyards thanks to its tolerance for human-modified habitats.
The American Robin eats both fruit and invertebrates. Earthworms are important during the breeding season, but fruit is the main diet during winter. Robins eat different types of food depending on the time of day; they eat earthworms early in the day and more fruit later in the day. Because the robin forages largely on lawns, it is vulnerable to pesticide poisoning and can be an important indicator of chemical pollution.
An American Robin can produce three successful broods in one year. On average, though, only 40 percent of nests successfully produce young. Only 25 percent of those fledged young survive to November. From that point on, about half of the robins alive in any year will make it to the next. Despite the fact that a lucky robin can live to be 14 years old, the entire population turns over on average every six years.
I photographed this American Robin in my backyard in 2007.
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