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How did antidepressant Pristiq get approved? Same way credit derivatives did 10-19-08
Once again Wyeth has disappointed investors.
It is withdrawing application for European approval of its new antidepressant
Pristiq, a derivative of its antidepressant Effexor (desvenlafaxine) on rumors
it won't be approved by the European Medicines Agency.
Of course many wonder why Pristiq was approved in the US either--14 months after
the FDA ordered a new safety study because of elevated liver enzymes and
cardiovascular events in test subjects.
Can anyone say lobbyist?
Especially since Pristiq isn't safe enough to be approved for menopausal hot
flashes yet according to the FDA--only for the depressed. Hello?
Like the financial derivatives which regulators waved through, Pristiq's
underlying asset, Effexor, is also suspect and subprime.
Less than 10 years after its 1993 US approval, Effexor, a
serotonin-norepinephrine reuptake inhibitor (SNRI), was found to cause greater
toxicity in overdoses and greater suicidality and serotonin syndrome than
comparable drugs.
Worse, Effexor's lead investigator has been Charles "Conflict of Interest"
Nemeroff whose audacious web of pharmaceutical financing ushered him to the
front page of the New York Times in October and stripped him of his Department
of Psychiatry and Behavioral Sciences chair at Emory University a week later.
"Surely you remember that…Wyeth-Ayers Pharmaceuticals has funded a Research
Career Development Award program in the department," wrote Nemeroff in defense
of his stipends to the medical school dean of Emory in 2000.
At the 2002 American Psychiatric Association annual meeting in Philadelphia,
Nemeroff proclaimed that Effexor XR, the controlled release form of Effexor,
achieved long-term remission in 67 percent of recurring depression patients.
But a warning letter to former Wyeth CEO Robert Essner from the FDA calls
Nemeroff's research which subsequently appeared in the Journal of Clinical
Psychiatry and Biological Psychiatry flawed.
"Specifically, by selecting only patients who responded to Effexor XR to
continue to the next phase of treatment, and by failing to properly account for
potential recurrent depressive episodes in those patients who discontinued
Effexor XR, the study design is biased in favor of Effexor XR treatment," wrote
Thomas Abrams, Director of the FDA's Division of Drug Marketing, Advertising,
and Communications in 2006.
Also flawed charged the letter is Wyeth's claim that over 20 million patients
have been treated with Effexor in 12 years because it counts the same patients
repeatedly rather than unique patients. (See: web sites; marketing claims.)
Wyeth "misbrands" Effexor said the FDA with the marketing lines, "Still
Depressed?" "Break the Cycle with Effexor XR" and "The Change They Deserve,"--a
slogan picked up by the Republican Party-- because the ads "cite no supporting
references but add to the misleading implication discussed above, that Effexor
XR is more effective than other antidepressants."
Though the FDA requested a written response from Wyeth "listing all violative
promotional materials for Effexor XR" and a "plan for discontinuing use of such
materials," a google search shows no response including on the FDA site or Wyeth
sites, though a retraction appeared in the Sept. 18 2008 New England Journal of
Medicine.
Like credit derivatives, Effexor salesmen know more about short term
effects--money!--than its long term effects like extreme withdrawal sequela
described by patient, Bruce Stutz and psychiatrist-turned-drug rep, Daniel
Carlat, in two different articles in the New York Times magazine last year.
"There was another problem: one of Effexor’s side effects. Patients who stopped
the medication were calling their doctors and reporting symptoms like severe
dizziness and lightheadedness, bizarre electric-shock sensations in their heads,
insomnia sadness and tearfulness. Some patients thought they were having strokes
or nervous breakdowns and were showing up in emergency rooms," writes Carlat, a
clinical professor of psychiatry at Tufts University School of Medicine who was
paid by Wyeth to promote Effexor to other doctors.
"At the Wyeth meeting in New York, these withdrawal effects were mentioned in
passing, though we were assured that Effexor withdrawal symptoms were uncommon
and could usually be avoided by tapering down the dose very slowly. But in my
practice, that strategy often did not work, and patients were having a very hard
time coming off Effexor in order to start a trial of a different
antidepressant," he says.
And like AIG, Fannie and Freddie and other derivative abusers, this is not the
first time Wyeth has played fast and loose with the truth.
While Wyeth extolled the off label use of its HRT drug Prempro for mood swings,
short-term memory loss, bladder problems and the risk of heart attack--women
should be on it from menopause until death Essner told his sales crew--Wyeth
knew for decades that HRT could cause breast cancer said the prosecution at the
retrial of 67-year-old double mastectomy patient Jennie Nelson in Philadelphia
last year. 5,200 more HRT related suits await.
Even the additional staggering $12 to $22 billion in suits Wyeth faces over side
effects from its withdrawn diet drug Fen-Phen parallels the financial crisis.
Why should a company that repeatedly violates the public trust even be in
business? Why should stockholders keep throwing good money after bad?