FacebookTwitterGoogle+RedditEmail

Seroquel’s Toll

Even though AstraZeneca’s antipsychotic Seroquel is the fifth best-selling medication in the US according to drugs.com, exceeded only by Lipitor, Nexium, Plavix and Advair diskus, its safety, effectiveness, clinical trial and promotion records are highly checkered.

An original backer, psychiatrist Richard Borison, was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme.

Its US medical director Wayne MacFadden had sexual affairs with two different women involved with Seroquel research, say published reports.

Chicago psychiatrist Michael Reinstein received $500,000 from AstraZenenca and wrote 41,000 prescriptions for Seroquel reports the Chicago Tribune and ProPublica.

Psychiatrist Charles Nemeroff who left Emory University in disgrace after a Congressional investigation for unreported pharma income, promoted Seroquel in continuing medical education courses according to the web site of psychiatrist Daniel Carlat.

Florida child psychiatrist Jorge Armenteros was chairman of the FDA committee responsible for recommending Seroquel approvals while a paid AstraZeneca speaker himself, said the Philadelphia Inquirer in 2009.

Psychiatrist Charles Schulz’ high profile pro-Seroquel presentations are suspected of being colored by his AstraZeneca income says the Minneapolis Star Tribune.

And unexplained Iraq and Afghanistan troop deaths are linked to Seroquel reported the Associated Press in August.

Originally approved for schizophrenia in 1997, Seroquel has subsequently been approved for bipolar disorder, for some groups of kids and as an add-drug for depression. This “indications creep” has mostly flown below the public’s radar. Seroquel expansion to treat children in late 2009, for example, was noted as a mere “label change” on the FDA web site. Hello?

Even without its depression indication, Seroquel is big business for AstraZeneca, earning $4.9 billion in sales in 2009. It is the drug that North Carolina’s Medicaid spends the most on: $29.4 million per year, reports the Charlotte News and Observer.

But now, as AstraZeneca rolls out its “Still Trying to Get Ahead of Your Depression” campaign, there are new questions about Seroquel’s safety and effectiveness.

According to an FDA warning letter, an AstraZeneca sales representative during an unsolicited sales call on January 3, 2008 sold Seroquel as a treatment for major depressive disorder to a physician before it was approved for MDD, an infraction which is illegal.

Once Seroquel was approved for depression (as an add-on treatment to an antidepressant for patients with major depressive disorder who not have an adequate response to antidepressant therapy), its leave-behind sheets drew another FDA warning letter.

AstraZeneca implied patients would achieve “remission” from depression with Seroquel XR (extended release) as opposed to with an antidepressant alone, says FDA — a claim not backed up by clinical experience.

Seroquel’s effect on depression has only been demonstrated in two, six-week trials FDA further said and six weeks is “not a long enough time period to adequately assess remission.” (It was approved…why?)

Also the case study of “Catherine F.” depicted in leave-behind sheets is inaccurate says FDA because it suggests Seroquel alleviates “symptoms of sadness and loss of interest when this has not been demonstrated by substantial evidence or substantial clinical experience.” (It was approved…why?)

Even AstraZeneca’s own briefing to the FDA committee in 2009 admits a “failed study” in which both Seroquel and Lexapro “failed to differentiate from placebo” which is Clinical Trial for “didn’t work.”

Nor did AstraZeneca adequately disclose Seroquel risks says FDA which include increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, hyperlipidemia, weight gain and other serious side effects.

In fact, in addition to risks like cataracts, seizures and increases in blood pressure in children and adolescents, already on the Seroquel label, FDA asked AstraZeneca to add the “risk of EPS and withdrawal syndrome in neonates” a few months ago: movement disorders which can affect mothers’ babies if the mothers are taking Seroquel and stop.

But the FDA might also look at what the government’s other hand is doing. In May the Office of the Army Surgeon General’s final report on the findings of its Pain Management Task Force unabashedly hawks Seroquel for an unapproved use.

“Physicians should consider these medications for sleep disorders,” says the 163-page report,” listing Ambien and Seroquel (quetiapine) “for nightmares” even though Seroquel has never been approved for insomnia, sleep disorders or “nightmares.”

Maybe the government will send itself a warning letter.

MARTHA ROSENBERG can be reached at: martharosenberg@sbcglobal.net

 

 

More articles by:

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).

Weekend Edition
December 14, 2018
Friday - Sunday
Andrew Levine
A Tale of Two Cities
Peter Linebaugh
The Significance of The Common Wind
Bruce E. Levine
The Ketamine Chorus: NYT Trumpets New Anti-Suicide Drug
Jeffrey St. Clair
Roaming Charges: Fathers and Sons, Bushes and Bin Ladens
Kathy Deacon
Coffee, Social Stratification and the Retail Sector in a Small Maritime Village
Nick Pemberton
Praise For America’s Second Leading Intellectual
Robert Hunziker
The Yellow Vest Insurgency – What’s Next?
Patrick Cockburn
The Yemeni Dead: Six Times Higher Than Previously Reported
Nick Alexandrov
George H. W. Bush: Another Eulogy
Brian Cloughley
Principles and Morality Versus Cash and Profit? No Contest
Michael F. Duggan
Climate Change and the Limits of Reason
Victor Grossman
Sighs of Relief in Germany
Ron Jacobs
A Propagandist of Privatization
Robert Fantina
What Does Beto Have Against the Palestinians?
Richard Falk – Daniel Falcone
Sartre, Said, Chomsky and the Meaning of the Public Intellectual
Andrew Glikson
Crimes Against the Earth
Robert Fisk
The Parasitic Relationship Between Power and the American Media
Stephen Cooper
When Will Journalism Grapple With the Ethics of Interviewing Mentally Ill Arrestees?
Jill Richardson
A War on Science, Morals and Law
Ron Jacobs
A Propagandist of Privatization
Evaggelos Vallianatos
It’s Not Easy Being Greek
Nomi Prins 
The Inequality Gap on a Planet Growing More Extreme
John W. Whitehead
Know Your Rights or You Will Lose Them
David Swanson
The Abolition of War Requires New Thoughts, Words, and Actions
J.P. Linstroth
Primates Are Us
Bill Willers
The War Against Cash
Jonah Raskin
Doris Lessing: What’s There to Celebrate?
Ralph Nader
Are the New Congressional Progressives Real? Use These Yardsticks to Find Out
Binoy Kampmark
William Blum: Anti-Imperial Advocate
Medea Benjamin – Alice Slater
Green New Deal Advocates Should Address Militarism
John Feffer
Review: Season 2 of Trump Presidency
Rich Whitney
General Motors’ Factories Should Not Be Closed. They Should Be Turned Over to the Workers
Christopher Brauchli
Deported for Christmas
Kerri Kennedy
This Holiday Season, I’m Standing With Migrants
Mel Gurtov
Weaponizing Humanitarian Aid
Thomas Knapp
Lame Duck Shutdown Theater Time: Pride Goeth Before a Wall?
George Wuerthner
The Thrill Bike Threat to the Elkhorn Mountains
Nyla Ali Khan
A Woman’s Selfhood and Her Ability to Act in the Public Domain: Resilience of Nadia Murad
Kollibri terre Sonnenblume
On the Killing of an Ash Tree
Graham Peebles
Britain’s Homeless Crisis
Louis Proyect
America: a Breeding Ground for Maladjustment
Steve Carlson
A Hell of a Time
Dan Corjescu
America and The Last Ship
Jeffrey St. Clair
Booked Up: the 25 Best Books of 2018
David Yearsley
Bikini by Rita, Voice by Anita
FacebookTwitterGoogle+RedditEmail