FDA committee to discuss anti-NGF drug class at meeting
WASHINGTON — A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.
The FDA Arthritis Advisory Committee will discuss the anti-nerve growth drug class that is being developed for the treatment of such conditions as osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics.
Drug makers participating in the meeting include Janssen, Pfizer and Regeneron.
New report on tobacco use among young people released by surgeon general
WASHINGTON — The U.S. surgeon general this week released a report on tobacco use among the nation’s youth.
"Preventing Tobacco Use Among Youth and Young Adults" details the scope, health consequences and influences that lead to youth tobacco use and proven strategies that prevent its use, surgeon general Regina Benjamin said. The new report marks the first made by the surgeon general since 2009, when President Barack Obama signed the bipartisan Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law.
To support the report, the surgeon general also released a guide that discusses was to address tobacco use among young people called "Preventing Tobacco Use Among Youth and Young Adults: We Can Make the Next Generation Tobacco-Free." What’s more, the Centers for Disease Control and Prevention’s Office on Smoking and Health will launch the Surgeon General’s Video Challenge to engage youth and young adults in developing original videos that feature one or more of the report’s findings.
"The addictive power of nicotine makes tobacco use much more than a passing phase for most teens. We now know smoking causes immediate physical damage, some of which is permanent," Benjamin said. "Today, more than 600,000 middle school students and 3 million high school students smoke. We don’t want our children to start something now that they won’t be able to change later in life."
The Food and Drug Administration praised the report’s release, saying it "not only documents the devastating consequences of tobacco use for our nation’s youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to keep kids off tobacco."
"[The] FDA welcomes the authoritative and comprehensive scientific findings in the surgeon general’s report and will use these facts as we propose tobacco product regulations to protect our nation’s health and to conduct science-based education campaigns to inform the public — particularly young people — about the harmful ingredients in tobacco products with the goal to prevent initiation," FDA commissioner Margaret Hamburg siad. "By applying the science contained in this and other surgeon general’s reports we can help make tobacco-related death and disease a part of America’s past, not its future."
Kerr Drug, UNC pharmacy school to collaborate in pharmacogenetic study
RALEIGH, N.C. — A regional retail pharmacy chain and a nearby school of pharmacy will collaborate on a study to evaluate the implementation of a pharmacogenetic program in a community pharmacy setting.
Kerr Drug announced Friday that it would work with the University of North Carolina Chapel Hill’s Eshelman School of Pharmacy to explore the feasibility of a program for Sanofi’s and Bristol-Myers Squibb’s blood-thinning drug Plavix (clopidogrel bisulfate).
Studies have recently shown that certain genetic variations between individuals can affect their responses to Plavix, and labeling for many drugs has been updated to include warnings of possible decreased response to therapy in some people.
"Because pharmacists have unique expertise in medication use and are point-of-care service providers, they can play an important role in facilitating pharmacogenetic testing and more personalized health care," Kerr Health EVP Rebecca Chater said. "This study will examine just how that role can be implemented."
During the six-month study, patients taking Plavix will be offered the opportunity to participate in the study through the pharmacy. They will then be screened and receive counseling at the pharmacy, with test results reviewed and interpreted by their pharmacists and prescribers.