LOL- Govt sent WARNING LETTER to stop Effexor from using "The change they deserve" (new GOP slogan)

[npincus]

:rofl:

On 12/10/07, the B*sh Admin's Department of Health and Human Services sent a warning letter to Wyeth, the manufacturer of the anti-depressant, Effexor XR, accusing them of misleading marketing practices, misleading consumers with unsupported claims of superior ty to other anti-depressant medications. One particular slogan the govt cited as unsupported and misleading was "the change you deserve". The letter requested that Wyeth STOP the disseminating of this promotional material IMMEDIATELY.

Why is that funny? Because the GOP just released their new slogan: "The change you deserve". :rofl: :rofl:

Adjectives that the gov't uses in the letter: misbranding", "misleading", "unsubstantiated superiority claims", "minimizes risks associated with use"... WOW, what a goldmine of IRONY! All apply (and more) to the deceptive and misleading self-promotion of the GOP! :rofl: :rofl:





http://partisanreport.com/blog/2008/05/12/new-change-from-gop-the-change-you-deserve/

Many House Republican leaders are looking for ways to reconnect with the American people to avoid potential further losses this fall, have released a new message for promise of “the change you deserve.”

“It starts with this: Washington is broken, the American people want it fixed, and Democrats in Washington have proven unable or unwilling to get the job done. Republicans will,” says the memorandum, a copy of which was obtained by The Washington Times.

The Democrats have trounced the Republicans in fundraising this year. So many are looking for new and inventive ways to reestablish that “Contract with America” that got them to power and kept them there for 12 years. But, because of their own policy failures, unbridled spending, and government expansion, it sent many packing. So I have a novel idea, stop with the theatrics and manifestos, and simply run and govern as Republicans, not neo-cons, or Democrats. Show me a group of candidates that will take charge in the war against spending, taxing, government expansion, and I’ll show you a reinvigorated base. Until then, save the drama.



http://www.fda.gov/cder/warn/2007/Effexor_XR-wl.pdf

WARNING LETTER

Dear Mr. Essner:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S.
Food and Drug Administration (FDA) has reviewed a professional journal ad submitted
by Wyeth Pharmaceuticals Inc. (Wyeth) for Effexor XR® (venlafaxine HCl) Tablets
(Effexor XR) under cover of Form FDA-2253. The journal ad is misleading because it
overstates the efficacy of Effexor XR, makes unsubstantiated superiority claims, in
addition to other unsubstantiated claims, and minimizes the risks associated with the
use of Effexor XR. Therefore, the piece misbrands the drug in violation of the Federal
Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 352(n) and FDA implementing
regulations, 21 CFR 202.1(e)(6)(i) & (6)(ii); (e)(7)(i). These violations are concerning
from a public health perspective because they suggest that Effexor XR is safer and
more effective than has been demonstrated.


(page 3)

Finally, the study provides no information about whether Effexor XR is superior to failed
therapy because study subjects were not randomized to their previously failed therapy.
Because improvement in depression can occur over time, subjects in the Effexor XR
arm of the study who responded well to treatment might have responded just as well
had they continued on the previously failed therapy.

Other claims in the ad cite no supporting references but add to the misleading
implication discussed above, that Effexor XR is more effective than other
antidepressants. For example, the claims:

• "Still depressed?

�� Anxiety, insomnia, low energy
�� Currently on an SSRI
�� Still suffering,”
“It may be time to make a change,"

• “Break the Cycle with EFFEXOR XR,” and

• “The change they deserve.” :rofl: :rofl: :rofl:

contribute to the impression that patients who have failed previous antidepressant
therapy can expect improvement when switching to Effexor XR when this has not been
demonstrated by substantial evidence or substantial clinical experience.


(page 5) :rofl:

Conclusion and Requested Action

For the reasons discussed above, the promotional piece misbrands Effexor XR in
violation of the Act, 21 U.S.C. § 352(n), and FDA implementing regulations, 21 CFR
202.1(e)(6)(i) & (6)(ii); (e)(7)(i).

DDMAC requests that Wyeth immediately cease the dissemination of violative
promotional materials for Effexor XR such as those described above. Please submit a
written response to this letter on or before December 21, 2007, stating whether you
intend to comply with this request, listing all violative promotional materials for Effexor
XR that are the same as, or similar to, those described above, and explaining your plan
for discontinuing use of such materials. Because the violations described above are
serious, we request, further, that your submission include a comprehensive plan of
action to disseminate truthful, non-misleading, and complete corrective messages about
the issues discussed in this letter to the audience(s) that received the violative
promotional materials. Please direct your response to me at the Food and Drug
Administration, Center for Drug Evaluation and Research, Division of Drug Marketing,
Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-
1266, or facsimile at 301-796-9878. In all future correspondence regarding this matter,
please refer to MACMIS # 15394 in addition to the NDA number. We remind you that
only written communications are considered official.