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Another Poorly Regulated "Derivative"--the Antidepressant Pristiq

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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. Hello?

Like the financial derivatives which regulators waved through, Pristiq's underlying asset, Effexor, is also iffy 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?

 

Martha Rosenberg is an award-winning investigative pubic health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by Random (more...)
 

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Another Poorly Regulated "Derivative"--the Antidepressant Pristiq

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