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UPDATE: VA AND WHITE HOUSE BLAST MEDIA FOR REPORTING
ON VETS' DRUG TESTS -- VA calls reports
"inaccurate and
misleading." White House says it's "irresponsible
reporting."
The original story on the VA's testing of the
drug Chantix is here...
http://www.vawatchdog.org/08/nf08/nfJUN08/nf061808-1.htm
Now, we have two pieces of information in
response to the published reports.
The first is a VA press release...and the second
is the transcript of remarks made by White House spokesman Tony Fratto.
VA press release here...
http://www.vawatchdog.org/08/vap08/vap061708-1.htm
Press release below:
-------------------------
Statement by the Department Of Veterans Affairs
On Smoking Cessation Research Program
June 17, 2008
WASHINGTON -- 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.
-------------------------
Statement from White House spokesman here...
http://www.whitehouse.gov/news/releases/2008/06/20080617-6.html
Statement below:
-------------------------
Q Yes, has the President seen the report on the
VA testing drugs on Iraq and Afghanistan vets? And if he's seen it and
have been briefed on it, does he have a reaction?
MR. FRATTO: I don't know if the President has seen it. I saw the
reporting in your paper and on -- I think it was ABC this morning. I
thought actually some of it was some of the most -- certainly at least
what I saw in television this morning was some of the more irresponsible
reporting that I've ever seen, in terms of taking what this one -- the
experience of this one veteran and trying to leave the impression that
this was a situation for all veterans.
We're in a difficult position in being able to comment on this case
because of the privacy concerns of the veteran in question and the other
veterans in this program. But I can tell you the VA is doing everything
they can to be mindful of the safety of these veterans in all their
programs, and trying to help them. This is the Veterans Administration
under wonderful leadership by General Peake -- Secretary Peake, who's
interested in the health and safety of these veterans that are under his
care. And every other member of that VA system is the same.
And to try to imply that -- and, in fact, not even imply -- I see the
words scrolled on a television screen this morning, that the VA is using
our veterans as guinea pigs I thought was one of the most awful things
I've ever had to watch on television. These are people who care for our
veterans, they care for the troops that have been out there every day
fighting for this country, and they're interested in their safety.
Remember, this is a program dealing with former soldiers with PTSD and
it's a smoking cessation program, and they're interested in helping these
veterans.
So that's my reaction to it.
-------------------------
posted by Larry
Scott
Founder and Editor
VA Watchdog dot Org
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