Navigation Links
Secretary Reinforces VA's Commitment to Research Safety and Veteran Focus
Date:7/9/2008

Research Has Set National Safety Standards, Benefits All Americans

WASHINGTON, July 9 /PRNewswire-USNewswire/ -- In a congressional hearing Secretary of Veterans Affairs James B. Peake, M.D., discussed the safety and importance of the research programs operated by the Department of Veterans Affairs (VA) as well as an absolute commitment to its patients, while expressing regret that even a single veteran would feel improperly treated or misused.

"VA has an outstanding research program, and has been innovative in its protection of human research subjects," Peake said before the House Committee on Veterans Affairs. "I am determined that VA will remain a leader in the protection of human research subjects and in veteran-centric research."

Peake pointed out VA researchers have played key roles in the development of breakthrough medical advancement such as the cardiac pacemaker, the CT scanner and improvements to artificial limbs. The first liver transplant was performed by a VA researcher. The Department's researchers have also conducted important trials on medication for tuberculosis, schizophrenia, high blood pressure, shingles and many other diseases that affect not only veterans but all Americans.

The VA secretary's remarks came in the wake of published reports in the Washington Times about a VA research program on smoking cessation involving veterans with post-traumatic stress disorder (PTSD). Peake emphasized the research project was not a drug study, but an examination of the most effective site of care to treat heavy smokers who have PTSD, using medications approved by the Food and Drug Administration (FDA).

"Veterans with PTSD are more likely to be heavy smokers and are only half as likely to quit as are smokers without PTSD in the general population and smoking kills," Peake said.

None of the medications used in this study are investigational or experimental, all are FDA approved, and the drug that made headlines, Chantix, is in fact considered to be the most effective medication available for smoking cessation with six million prescriptions written.

Peake noted any veterans receiving Chantix in the study or anywhere in the VA had been put on the drug by their doctors as an individual doctor-patient decision, with continued monitoring the health status. As information within the VA and by the FDA suggested potential psychological side effects were being seen in some patients taking Chantix, Clinical providers were notified promptly. Not only were letters sent by researchers to members of the study, but, additionally, a letter has been sent to every veteran prescribed Chantix by the VA discussing possible side-effects, encouraging them to contact their provider immediately if they experience side effects and assuring them that the VA will help them find another way to quit smoking if they are concerned about Chantix or are having side effects.

More than 60 FDA approved drugs could have adverse effects that may include "suicidal ideation and suicidal behavior," Peake said. "If VA were to withhold these medications from our patients with mental health issues, we would have great difficulty treating them. Weighing the risk -- and all drugs have risks -- against the benefit with the best information available is what the doctor and patient do as a drug is prescribed."

The Secretary also addressed allegations implying VA research is somehow compromised by outside entities such as drug companies and universities calling it ridiculous. The smoking cessation study was solely funded by the VA, with no outside funding. VA research is approved by VA's Office of Research and Development and does not require approval from the Secretary, including this smoking cessation study. The scientific review and human subjects protection processes ensure that VA research addresses specifically and only the purpose of the study.

Peake has also directed four internal investigations:

-- A comprehensive review of the smoking cessation study within 30 days;

-- A review of all PTSD drug protocols in the VA system within 45 days;

-- A full review of our adverse event reporting system for pharmaceuticals within 20 days;

-- A review of VA's medication notification system to ensure the system's policies support timely communications to our patients and providers within 20 days.

Peake said his intent is to ensure the best, the most ethical, and the safest scientific inquiries into the health care needs of our nation's veterans.


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

Related medicine technology :

1. Health Secretary Reminds Kids to Stop Germs - Wash Hands
2. Eisais Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting
3. GeoVax Secures $10 Million Financing Commitment
4. On Second Anniversary, Compendia Bioscience Announces Significant Revenue Growth, Completion of Product Milestone and Expansion of Pharma Customer Commitments
5. Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepatitis (ANRS)
6. University of Rochester Researcher Named Millennium Pharmaceuticals Career Development Scholar of The Leukemia & Lymphoma Society
7. Pediatric Researchers Find Possible Master Switch Gene in Juvenile Arthritis
8. Childrens Brain Tumor Foundations Tissue Bank Consortium May Solve Dire Problem in Pediatric Cancer Research
9. Small Business Innovation Research Program Awards Grant to Biomoda
10. Intellect Neurosciences, Inc. and Medical Research Council Technology (U.K.) Reach Important Milestone in Generating an Alzheimers Therapeutic Antibody
11. New Research Just Released: Women Can Now Safely Postpone Motherhood Until Time Is Right
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... LAWRENCE, Mass. , Oct. 4, 2017 /PRNewswire/ ... developer of single-use, self-contained, illuminating medical devices, today ... National Health Surveillance Agency (or Agência Nacional ... ®. The first single-use, cordless surgical retractor with ... ONETRAC provides optimal access, illumination and exposure of ...
(Date:10/2/2017)... Denmark , Oct. 2, 2017 The Rebound ... in the struggle to reverse the tide of prescription drug ... for regulating their medicine intake and stepping down their dosage ... set to launch in December 2017; the first 100,000 people ... Learn more at http://www.rebound-solution.com/ ...
(Date:9/25/2017)... Sept. 25, 2017   Montrium , an ... solutions, today—from the IQPC Trial Master Files & ... NL)—announced that EastHORN Clinical Services has selected ... and TMF management. EastHORN, a leading European contract ... to increase transparency to enable greater collaboration with ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance Group, ... Dallas, Miami, and Raleigh regions, is organizing an extended charity drive to benefit ... deadly chromosome abnormality. , After struggling since birth with several health challenges, T.J. ...
(Date:10/13/2017)... ... October 13, 2017 , ... The International ... promote standards of excellence for the field of eating disorders, announces the opening ... 25, 2018 in Orlando, Florida at the Omni Resort at ChampionsGate. ...
(Date:10/13/2017)... LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for care ... is the 90-day elimination period, when the family pays for care, is often waived, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob ... sciatica in a new episode of "Success Files," which is an award-winning educational ... and investigates each subject in-depth with passion and integrity. , Sciatica occurs when ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... now treating sleep apnea using cutting-edge Oventus O2Vent technology. As many ... sleep disorder characterized by frequent cessation in breathing. Oral appliances can offer significant ...
Breaking Medicine News(10 mins):