Navigation Links
VA Statement on Smoking Cessation Research Program
Date:6/17/2008

WASHINGTON, June 17 /PRNewswire-USNewswire/ -- Reports in the news media today that the Department of Veterans Affairs (VA) is testing drugs on war veterans are inaccurate and misleading. VA conducts extensive and often groundbreaking, evidence-based research nationwide to discover better health care methods for our veterans. In our PTSD and smoking cessation study, our research is to learn if it is easier to stop smoking when smoking cessation treatment is combined with PTSD therapy, or whether the two therapies are more effective if they are provided separately. In either case, patients are receiving treatment recommended by their own doctors using counseling with or without FDA approved medication that includes Varenicline (Chantix). Participation in this program is voluntary, and all participants are closely monitored clinically by mental health professionals who provide smoking cessation methods patients agree to use.

More than six million prescriptions were written for Varenicline in the United States in 2007; it is an FDA-approved, widely used medication for smoking cessation. In November, 2007, FDA issued an "early communication" to health care providers indicating concerns had arisen about the medication having a possible side effect involving mental health; VA immediately passed along that concern to practitioners at all of our medical centers. On February 1, FDA issued a "Public Health Advisory," to providers, providing more information on potential side effects of which clinicians and patients should be aware. VA distributed this alert to pharmacists in its system on that same day, and to researchers on February 5. FDA has never asked that Varenicline be removed from the market, and it continues to be FDA approved as a safe and efficacious medication.

It is important to note that neither FDA nor the manufacturer has ever recalled Varenicline, and VA has never been asked to do so.

Had a recall been requested, VA would immediately have notified patients and stopped refilling prescriptions, standard procedure when such recalls occur. VA's letter to patients in the study using Varenicline was carefully written by a team of psychiatrists and psychologists, and clearly and specifically requested patients to come in and discuss possible side effects of which they should be aware; these professionals felt that the issue of suicide should be discussed in a clinical setting, not in a mailing to a group of patients.

The implication that a modest payment for volunteers in medical research programs is somehow wrong is a distortion. Such payments are a widely used practice, both in VA and in the private sector, to help volunteers pay for expenses. The characterization of the purpose of these payments was entirely incorrect.

Treating PTSD is very important to VA and to veterans, and smoking can kill. This research program, like all VA research, is approved by independent institutional review boards to ensure the safety of all participants. The progress of the study is regularly scrutinized by a VA Data Safety Monitoring Board that closely tracks any and all reported side effects related to the study to ensure safety.

VA's use of Varenicline is consistent with guidelines on smoking cessation the U.S. Surgeon General's office has established. VA is committed to the ethical treatment of all who participate in our research studies, to the principle of informed consent, and to treating veterans participating in our research programs with the highest quality and most advanced health care available. The VA cares about every veteran who suffers from PTSD, and that concern reinforces our obligation to quality research and providing the best treatments possible.


'/>"/>
SOURCE U.S. Department of Veterans Affairs
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
2. Statement From The National Conclave on HIV/AIDS Policy for Black Clergy
3. Statement by US Oncology on FDA Label on Erythropoiesis Stimulating Agents (ESAs)
4. AIDS Action Council Statement on World AIDS Day 2007: Leadership Needed for a National Strategy to Stop the AIDS Epidemic
5. Statement of Andrea Kavanagh, Director, Pure Salmon Campaign, on the Science Sea Lice Study
6. Statement from the American Diabetes Association Related to ACCORD Trial Announcement
7. Media Statement: MHA Keystone Center for Patient Safety & Quality OHRP Ruling
8. Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
11. RediClinic Offers Affordable New Plan Clinically Shown to Double a Persons Chance to Stop Smoking
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... Feb. 11, 2016 Brain Cancer patients ... method at West Cancer Center . Optune™, ... to inhibit cancer cell replication causing death of cancer ... a decade to show a significant extension in overall ... patients. Currently, West Cancer Center is the only medical ...
(Date:2/11/2016)... 2016 Jeffrey Zucker , vice ... will present at this year,s Summit for Clinical Operations Executives ... Miami, FL. Zucker will discuss how ... execution, supporting SCOPE,s "Improving Site Study Activation and Performance" portion ... Feb. 25 at 11:05 a.m. --> ...
(Date:2/11/2016)... Ohio , Feb. 11, 2016  Community pharmacists ... increasing efficiency for the pharmacy through a custom-built medication ... Schieber , pharmacist and owner at Schieber Family ... "We can get a lot of patients enrolled in ... for everybody. It,s a win for the patient, and ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... February 11, 2016 , ... According to an article ... as a weight loss dietary supplement, is being recalled due to the discovery that ... because there is not a single supplement on the market proven to help people ...
(Date:2/11/2016)... ... February 11, 2016 , ... Dr. Sadati’s recent feature ... procedures. Along with performing procedures, the magazine also highlights that Dr. Sadati has ... One of the most common procedures he performs is his natural facelift. “As ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... The president ... DoD Military Health System but would shift more of the cost burden to military ... TRICARE-reform plan laid out in the defense budget as including limited quantifiable benefit fixes ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... surgery, dermatology and women’s health, is pleased to announce the promotions of Allison ... Partners sales team, Steve Catone to executive vice president of North American capital ...
(Date:2/11/2016)... Laurel, NJ (PRWEB) , ... February 11, 2016 ... ... announces the call for nominations seeking candidates for the Board of Commissioners. Individuals ... with passion, skills and experience with diversity of clinical practice settings and across ...
Breaking Medicine News(10 mins):