PRESTIGIOUS MEDICAL GROUP BACKS AMVETS ON BIOLOGIC DRUGS

Wall Street Journal ad by North American Thrombosis Forum calls for safety first on Biosimilars

LANHAM, Md. Feb. 2, 2010—AMVETS National Commander Duane J. Miskulin Tuesday applauded the North American Thrombosis Forum (NATF) for its position on biologic drugs and the group’s proposal for clinical trials of biosimilar drugs calling it a thoughtful approach that puts veteran patients’ safety first.

The NATF published an advertisement in the January 27 edition of the Wall Street Journal calling for rigorous clinical testing of copies of existing biologic drugs, echoing safety concerns voiced in a recent AMVETS editorial. Biologic drugs, such as heparin, growth hormones and typed of insulin found in the Department of Veterans Affairs National Drug Formulary, are made from living tissue rather than chemical components found in ordinary pharmaceuticals. This unique structure makes it impossible to create exact generic replicas of a biologic drug, raising patient safety questions about biosimilars.

“The medical care of disabled veterans is one of our highest priorities and the North American Thrombosis Forum recognizes the same safety issues that AMVETS raised last year,” said Miskulin. “Their thoughtful approach puts veterans’ safety first by proposing rigorous clinical trials of new biosimilars.”

In 2009, AMVETS called for similar testing of biologic copies to determine whether they would be equivalent to original biologics and to determine whether new biosimilars can be safely interchanged with innovator drugs.

AMVETS was an early advocate for stringent testing protocols for copies of biologic drugs. The veterans’ group noted in congressional correspondence and in media reports that a number of biologic drugs are currently on the VA’s National Drug Formulary and are prescribed to disabled veterans. AMVETS also urged in a July 2009 editorial in The Hill that Congress close a regulatory “loophole” that would exempt from rigorous clinical testing a number of copies of biologic drugs currently prescribed to disabled veterans through the VA health care system.

“I commend the North American Thrombosis Forum for their dedication to patient safety, especially as it related to our veterans,” said Miskulin. “We strongly support the development of generic drugs and biosimilars that can lead to better health care for veterans at lower cost but we must not place the health of disabled veterans in jeopardy just to save money.”

About AMVETS:
A leader since 1944 in preserving the freedoms secured by America’s armed forces, AMVETS provides support for veterans and the active military in procuring their earned entitlements, as well as community service and legislative reform that enhances the quality of life for this nation’s citizens and veterans alike. AMVETS is one of the largest congressionally-chartered veterans’ service organizations in the United States, and includes members from each branch of the military, including the National Guard and Reserves. To learn more visit www.amvets.org.