FacebookTwitterGoogle+RedditEmail

Prescribed and Abandoned

by MARTHA ROSENBERG

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.”

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 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. END

Martha Rosenberg’s is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

 

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

More articles by:

CounterPunch Magazine

minimag-edit

Weekend Edition
August 26, 2016
Friday - Sunday
Andrew Levine
How Donald Trump Can Still be a Hero: Force the Guardians to the Duopoly to Open Up the Debates
Louisa Willcox
The Unbearable Killing of Yellowstone’s Grizzlies: 2015 Shatters Records for Bear Deaths
Charles Pierson
Wedding Crashers Who Kill
Richard Moser
What is the Inside/Outside Strategy?
Patrick Cockburn
Turkey’s Foray into Syria: a Gamble in a Very Dangerous Game
Brian Terrell
What Makes a Hate Group?
Dirk Bezemer – Michael Hudson
Finance is Not the Economy
Howard Lisnoff
Trouble in Political Paradise
Ben Debney
The Swimsuit that Overthrew the State
Ashley Smith
Anti-imperialism and the Syrian Revolution
Vincent Navarro
Is the Nation State and Its Welfare State Dead? a Critique of Varoufakis
John Wight
Syria’s Kurds and the Wages of Treachery
Lawrence Davidson
The New Anti-Semitism: the Case of Joy Karega
Mateo Pimentel
The Affordable Care Act: A Litmus Test for American Capitalism?
Roger Annis
In Northern Syria, Turkey Opens New Front in its War Against the Kurds
David Swanson
ABC Shifts Blame from US Wars to Doctors Without Borders
Norman Pollack
American Exceptionalism: A Pernicious Doctrine
Ralph Nader
Readers Think, Thinkers Read
Julia Morris
The Mythologies of the Nauruan Refugee Nation
Ann Garrison
Unworthy Victims: Houthis and Hutus
Julian Vigo
Britain’s Slavery Legacy
Rivera Sun
Accountability: An Abandoned American Value
Philip Doe
Colorado: 300 Days of Sunshine Annually, Yet There’s No Sunny Side of the Street
Joseph White
Homage to EP Thompson
Kollibri terre Sonnenblume
DNC Playing Dirty Tricks on WikiLeaks
Ron Jacobs
Education for Liberation
Jim Smith
Socialism Revived: In Spite of Bernie, Donald and Hillary
Robert Koehler
The Heart of Order
David Macaray
Organized Labor’s Inferiority Complex
David Cortright
Alternatives to Military Intervention in Syria
Binoy Kampmark
The Terrors of Free Speech: Australia’s Racial Discrimination Act
Cesar Chelala
Guantánamo’s Quagmire
Andrew Stewart
Did Gore Throw the 2000 Election?
William Hughes
From Sam Spade to the Red Scare: Dashiell Hammett’s War Against Rightwing Creeps
Raouf Halaby
Dear Barack Obama, Please Keep it at 3 for 3
Charles R. Larson
Review: Paulina Chiziane’s “The First Wife: a Tale of Polygamy”
August 25, 2016
Mike Whitney
The Broken Chessboard: Brzezinski Gives Up on Empire
Paul Cox – Stan Cox
The Louisiana Catastrophe Proves the Need for Universal, Single-Payer Disaster Insurance
John W. Whitehead
Another Brick in the Wall: Children of the American Police State
Lewis Evans
Genocide in Plain Sight: Shooting Bushmen From Helicopters in Botswana
Daniel Kovalik
Colombia: Peace in the Shadow of the Death Squads
Sam Husseini
How the Washington Post Sells the Politics of Fear
Ramzy Baroud
Punishing the Messenger: Israel’s War on NGOs Takes a Worrying Turn
Norman Pollack
Troglodyte Vs. Goebbelean Fascism: The 2016 Presidential Race
Simon Wood
Where are the Child Victims of the West?
FacebookTwitterGoogle+RedditEmail