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

bernie-the-sandernistas-cover-344x550

zen economics

Weekend Edition
December 09, 2016
Friday - Sunday
Jeffrey St. Clair
Roaming Charges: Nasty As They Wanna Be
Henry Giroux
Trump’s Second Gilded Age: Overcoming the Rule of Billionaires and Militarists
Andrew Levine
Trump’s Chumps: Victims of the Old Bait and Switch
Chris Welzenbach
The Forgotten Sneak Attack
Lewis Lapham
Hostile Takeover
Joshua Frank
This Week at CounterPunch: More Hollow Smears and Baseless Accusations
Paul Street
The Democrats Do Their Job, Again
Vijay Prashad
The Cuban Revolution: Defying Imperialism From Its Backyard
Michael Hudson - Sharmini Peries
Orwellian Economics
Mark Ames
The Anonymous Blacklist Promoted by the Washington Post Has Apparent Ties to Ukrainian Fascism and CIA Spying
Erin McCarley
American Nazis and the Fight for US History
Yoav Litvin
Resist or Conform: Lessons in Fortitude and Weakness From the Israeli Left
Conn Hallinan
India & Pakistan: the Unthinkable
Andrew Smolski
Third Coast Pillory: Nativism on the Left – A Realer Smith
Joshua Sperber
Trump in the Age of Identity Politics
Brandy Baker
Jill Stein Sees Russia From Her House
Katheryne Schulz
Report from Santiago de Cuba: Celebrating Fidel’s Rebellious Life
Nelson Valdes
Fidel and the Good People
Norman Solomon
McCarthy’s Smiling Ghost: Democrats Point the Finger at Russia
Renee Parsons
The Snowflake Nation and Trump on Immigration
Margaret Kimberley
Black Fear of Trump
Michael J. Sainato
A Pruitt Running Through It: Trump Kills Nearly Useless EPA With Nomination of Oil Industry Hack
Ron Jacobs
Surviving Hate and Death—The AIDS Crisis in 1980s USA
David Swanson
Virginia’s Constitution Needs Improving
Louis Proyect
Narcos and the Story of Colombia’s Unhappiness
Paul Atwood
War Has Been, is, and Will be the American Way of Life…Unless?
John Wight
Syria and the Bodyguard of Lies
Richard Hardigan
Anti-Semitism Awareness Act: Senate Bill Criminalizes Criticism of Israel
Kathy Kelly
See How We Live
David Macaray
Trump Picks his Secretary of Labor. Ho-Hum.
Howard Lisnoff
Interview with a Political Organizer
Yves Engler
BDS and Anti-Semitism
Adam Parsons
Home Truths About the Climate Emergency
Brian Cloughley
The Decline and Fall of Britain
Eamonn Fingleton
U.S. China Policy: Is Obama Schizoid?
Graham Peebles
Worldwide Air Pollution is Making us Ill
Joseph Natoli
Fake News is Subjective?
Andre Vltchek
Tough-Talking Philippine President Duterte
Binoy Kampmark
Total Surveillance: Snooping in the United Kingdom
Guillermo R. Gil
Vivirse la película: Willful Opposition to the Fiscal Control Board in Puerto Rico
Patrick Bond
South Africa’s Junk Credit Rating was Avoided, But at the Cost of Junk Analysis
Clancy Sigal
Investigate the Protesters! A Trial Balloon Filled With Poison Gas
Pierre Labossiere – Margaret Prescod
Human Rights and Alternative Media Delegation Report on Haiti’s Elections
Charles R. Larson
Review:  Helon Habila’s The Chibok Girls: the Boko Haram Kidnappings and Islamist Militancy in Nigeria
David Yearsley
Brahms and the Tears of Britain’s Oppressed
FacebookTwitterGoogle+RedditEmail