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:4/18/2017)... , April 18, 2017 Viverae ® ... to announce the integration of IBM ® Watson ... to deliver targeted communications for a personalized experience. Through ... actions on their health in real time. The enhanced ... matter most to members, wherever they are in their ...
(Date:4/18/2017)... 2017  Astute Medical, Inc., developer of biomarkers for ... presented at the 2017 National Kidney Foundation (NKF) ... through April 22. Physicians will present data on two ... risk for acute kidney injury (AKI) during the management ... Elevated levels of TIMP-2 and IGFBP-7 have ...
(Date:4/18/2017)... SUNNYVALE, Calif. , April 18, 2017 /PRNewswire/ ... results of collaboration started in 2016, in which ... "Artificial Brain SOINN". The companies achieved initial results ... ultrasound solution by Artificial Brain SOINN. The results ... Tokyo Big Sight, April 19-21, at booths 4505 ...
Breaking Medicine Technology:
(Date:4/21/2017)... ... April 21, 2017 , ... The adage “Show, don’t tell” applies perfectly ... in the company’s esteemed VISION House demonstration project series. Manifesting the concept of right-sized ... resources they need to live affordably and abundantly without unduly taxing the resources of ...
(Date:4/21/2017)... ... April 21, 2017 , ... The Hong Kong Polytechnic University ... printing facility among higher education institutions in Hong Kong to support teaching, learning and ... the range and quantity of facilities in Hong Kong. , With an area ...
(Date:4/21/2017)... ... April 21, 2017 , ... Alive for Wellness is a group ... mental health struggles. The Alive team uses advanced behavioral sciences treatment modalities to ... with a mental health struggle is based on 10 modalities of treatment ...
(Date:4/21/2017)... ... April 21, 2017 , ... ... category of International Trade, the UK’s most prestigious award for business success. ... 95% of total revenues and has grown by a total of 400% over ...
(Date:4/21/2017)... ... , ... BrightStar Care Salt Lake City, a home care agency that also ... has appointed Rex Wheeler as its new Director of Business Development. “This partnership helps ... ability to provide quality care to the community,” said Tammara Brown, owner of BrightStar ...
Breaking Medicine News(10 mins):