General News

Prescribed and Abandoned; Another Drug Settlement

By (about the author)     Permalink       (Page 1 of 1 pages)
Related Topic(s): ; ; ; ; ; ; ; , Add Tags Add to My Group(s)

View Ratings | Rate It

opednews.com Headlined to H4 11/13/12

Become a Fan
  (71 fans)

(Article changed on November 13, 2012 at 17:02)

It was supposed to replace the millions Wyeth lost when its hormone drugs Prempro and Premarin tanked in 2002 thanks to links to breast cancer, heart disease, blood clots and strokes.   So many women quit the Wyeth menopause drugs when the risks surfaced, the company announced it would close its Rouses Point, NY plant where it manufactured them and   eliminate 1,200 jobs. No wonder Pristiq, a serotonin/norepinephrine reuptake inhibitor (SNRI) looked like the way to retain the lucrative menopause market. It wasn't a hormone.
The good news and bad by Martha Rosenberg

But the FDA had other plans. Though it approved Pristiq in 2008 for the treatment of adults with major depressive disorder, it gave no such green light to Pristiq for hot flashes associated with menopause. There were too many safety signals.

Why did two women in the study group taking Pristiq have heart attacks and three need procedures to repair clogged arteries compared with none taking placebo, asked the FDA? Why did trials disclose serious liver complications?   How could Wyeth assure the long term safety of Pristiq when 604 of the 2,158 test subjects took it for only six months? Seventeen suicides were also reported in Pristiq's post-marketing data.

This week Pfizer, who acquired Wyeth in 2009, agreed to settle a class-action lawsuit by former Wyeth shareholders claiming they were misled about Pristiq's risks, for $67.5 million. Pristiq has already cost the company severely, losing it $7.6 billion in market value when the FDA refused the menopause indication, reports Reuters.

Even before this week's settlement, Pristiq had few friends in the Pharma community. "Pristiq is not a good drug by any standard," wrote an anonymous poster on the industry chatroom cafepharma when the FDA declined the menopause indication.

"We tried to get 100 mg approved as the standard dose. But our patients got so sick that they care less about the efficacy," wrote another poster. "They just couldn't tolerate the drug long enough to see any improvement."

Smelling blood in the water at Wyeth's setback other posters piled on. "No study exists showing any antidepressant including Pristiq works any better than a placebo for reducing hot flashes, which are subjective anyway and only last a few minutes long at worst," wrote another industry insider. "That is a heavy price to pay to take a heavy duty drug 24/7 for a few minutes of daily relief that a sugar pill also provides. FDA is crazy (or bought) if they allow this unproven drug travesty on the market."

Would women want to trade "hot flashes for decreased libido, nausea, increased blood pressure and incredible withdrawal issues" found with Pristiq asked another poster? "Women and their physicians are not as gullible as they were back in the Premarin days."

Psychiatrist Daniel Carlat, who wrote a 2007 New York Times Magazine expose about working as a Wyeth-paid spokesman selling Effexor to other doctors, also weighed in on Pristiq. "Every patient who takes Effexor produces Pristiq in their own body, at no additional charge," he wrote in a blog article titled "Top 5 Reasons to Forget about Pristiq."

.

The hormone drugs made by Pfizer, formerly Wyeth, proved so harmful to women, many said the "H" in HRT stood for hoax. This week's Pristiq settlement suggests there are more drugs in the hoax category. END

Martha Rosenberg's acclaimed Born with a Junk Food Deficiency is now available in bookstores, libraries and online.

 

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...)
 

Share on Google Plus Submit to Twitter Add this Page to Facebook! Share on LinkedIn Pin It! Add this Page to Fark! Submit to Reddit Submit to Stumble Upon

The views expressed in this article are the sole responsibility of the author and do not necessarily reflect those of this website or its editors.

Writers Guidelines

Contact Author Contact Editor View Authors' Articles

Most Popular Articles by this Author:     (View All Most Popular Articles by this Author)

Grassley Investigates Lilly/WebMD link Reported by Washington Post

The Drug Store in Your Tap Water

Are You Sure You're Not Psychotic Asks Shameless Drug Company?

It's the Cymbalta Stupid

MRSA and More. Antibiotics Linked to Obesity and Allergies, Too

Another Poorly Regulated "Derivative"--the Antidepressant Pristiq

Comments

The time limit for entering new comments on this article has expired.

This limit can be removed. Our paid membership program is designed to give you many benefits, such as removing this time limit. To learn more, please click here.

Comments: Expand   Shrink   Hide  
No comments