Prescribed and Abandoned--Another Drug Settlement

[Skyler]

Prescribed and Abandoned--Another Drug Settlement

by Martha Rosenberg

November 15, 2012

Alternet

 

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.

 

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."

 

.....................................

 

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 exposé 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.” Pristiq is a metabolite of Wyeth's antidepressant Effexor XR which netted $3.7 billion in 2006 and was viewed as an unabashed patent extender for when Effexor XR went off patent in 2010.

 

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. Read More

Edited November 19, 2012 by Altostrata
added author name to conform to Creative Commons Attribution License

[Barbarannamated]

Excellent!

 

I believe there are MANY more drugs in the hoax category. The Women's Health Initiative is very convoluted with Wyeth calling alot of the shots. They began the fight against bioidentical hormones during that time also. Compounded bioidenticals are not patentable, but are competition to patented hormone products such as Prempro, etc. ('Natural' is a different category and I'm not certain of distinction)

 

I won't claim to understand all of the risks and benefits of hormones. It differs from person to person. However, my thought, as of today, is that they are less dangerous than the drugs used for conditions they may help: osteoporosis, hyperlipidemia, heart disease, etc. I'm not referring to using them for menopausal symptoms only.

 

*Opinion subject to change*

 

I think there's alot more to this story.

[Altostrata]

Thanks, Schuyler. Please add source, author, and date when posting pointers to articles.

[Skyler]

I believe there are MANY more drugs in the hoax category.

Kinda hair raising, even when we know this stuff goes on it never ceases to stupify.

 

Thanks, Schuyler. Please add source, author, and date when posting pointers to articles.

 

Oops... knew I was forgetting something!

 

Posted by Martha Rosenberg on Alternet.org at 11:54 am November 15, 2012

[alexjuice]

How do you guys think the new national health overhaul will affect the drug companies? My first thought is that the influx of new patients with first time insurance will stress capacity resulting in more quickie visits that end with a script -- like I've seen from the guys I know who went through Texas Health Services. This will increase orders from the drug manufacturers, I'd assume. What do you guys think?

 

Not to debate merits of the incoming system. We have what we have. I'm just spitballing how it might play out.

 

//and sorry to hijack.

[compsports]

How do you guys think the new national health overhaul will affect the drug companies? My first thought is that the influx of new patients with first time insurance will stress capacity resulting in more quickie visits that end with a script -- like I've seen from the guys I know who went through Texas Health Services. This will increase orders from the drug manufacturers, I'd assume. What do you guys think?

 

Not to debate merits of the incoming system. We have what we have. I'm just spitballing how it might play out.

 

//and sorry to hijack.

 

I sadly agree Alex.

 

I also think the increased emphasis on evidenced based medicine that I believe Obama Care is emphasizing is going to result in more prescriptions for drugs. I mean, drugs are the answer to everything, right?

 

CS

[Jemima]

I also think the increased emphasis on evidenced based medicine that I believe Obama Care is emphasizing is going to result in more prescriptions for drugs. I mean, drugs are the answer to everything, right?

 

CS

 

Especially when Big Pharma can hokey up the evidence to suit their purposes!

[Skyler]

 

I also think the increased emphasis on evidenced based medicine that I believe Obama Care is emphasizing is going to result in more prescriptions for drugs. I mean, drugs are the answer to everything, right?

 

CS

 

Especially when Big Pharma can hokey up the evidence to suit their purposes!

 

Evidence based means it's possible to measure 'outcomes' and spin the results, all bias strictly intentional.

[Barbarannamated]

"Evidence-based medicine"

[¡¡ insert screaming, pulling- hair-out-while-holding-hands-over-ears emoticon !!]

 

BAD subject in my home as hubby's work is to enforce treatment guidelines backed by EBM.

He's read some of Whitaker's and Kirsch's work and is realizing the poor design and outright fraud of antidepressant studies.

But then maintains that "the treatment guidelines for chronic pain uphold SNRIs as 1st line.."

Go figure!

 

Sorry. What was the original question??

 

Where will Obamacare take us? Nowhere good, I'm afraid, although I don't believe it's a party issue. Pharma runs healthcare (and health insurance) in a bipartisan manner.

 

Also, EBM leaves no room for Outliers nor does it allow or encourage doctors to think for themselves. Their diagnostic skills are obsolete, replaced by a cookie-cutter algorithm.

[Barbarannamated]

FYI.

FEDS propose Obamacare rule that boosts pharma

Pharmalot

 

http://www.pharmalot.com/2012/11/feds-propose-obamacare-rule-that-boosts-pharma/