FacebookTwitterGoogle+RedditEmail

Fragile: Handle with Risperdal

by MARTHA ROSENBERG

The email did not beat around the bush.

“The rationale of this center,” wrote Christine Cote, VP of Janssen’s Medical Affairs about the planned MGH-Johnson & Johnson Center for the Study of Pediatric Psychopathology at Massachusetts General Hospital, “is to generate and disseminate data supporting the use of risperidone in this patient population.”

Okaaaaay.

But even as postmortems are performed on the unholy alliance between Massachusetts General Hospital and Johnson & Johnson which surfaced last year, the drug giant is at it again.

In January, Janssen Pharmaceutica N.V., a unit of Johnson & Johnson, announced it was funding a research venture at Vanderbilt University in Nashville, TN to discover “novel drugs for the treatment of schizophrenia,” to be led by Jeffrey Conn, former head of Merck’s department of neuroscience.

Of course you can’t blame J&J for seeking new academic stomping grounds.

Its chief academic cheerleader, Harvard child psychiatrist Joseph Biederman, who headed its center at Mass Gen, has been benched for apparent psychopathology-for-pay schemes under which he increased the diagnosis of pediatric bipolar disorder fortyfold.

Janssen is being sued by Texas, New Mexico and other states for hiding Risperdal dangers, marketing it for unapproved uses, ghostwriting, misleading doctors, falsifying science, kickback schemes and wholesale Medicaid fraud.

And–Risperdal’s US patent expired in 2008!

Risperdal (risperidone), an atypical antipsychotic, may have contributed to the deaths of 31 childrensince its 1993 approval according to the New York Times–including 11 treated for unapproved uses; it may have squandered millions of tax dollars, but it is a branding success story.

How else do you explain a drug for schizophrenia–1 per cent of the population–bipolar disorder–2.5 per cent–and autism-related irritability in children 5-16–less than 1 per cent of kids–becoming the seventh best selling med in the world in 2007? Of course some of Risperdal’s success came from the award-winning “Living Nightmares” campaign by London-based ad agency Junction 11 which used Welsh artist Mark Moran’s evocative oil paintings Dog-Woman, Witches, Rotting Flesh and Boiling Rain–get it?– based on case histories to “own the relapse/prevention space” as art director John Timney put it.

And don’t forget the Prescribe Early campaign by ad agency Torre Lazur McCann which used a macabre abandoned wallet, teddy bear and keys on a barren street to “to reposition a drug that was being used too late to achieve its maximum benefits,”–look what happens when you wait!–according to Pharma Times magazine.

Nor did the continuing medical education courses like “Individualizing ADHD Pharmacotherapy with Disruptive Behavioral Disorders” taught by the J&J funded Robert L. Findling and referring to Risperdol/risperdone 13 times hurt. Credit was available until 2009.

But most of Risperdal’s success comes from the unsung doctors–you know who you are–who extolled the drug for unapproved use in pediatric bipolar disorder, ADHD, depression, “agitated, expansive, grandiose” “psychopathologies” [per Biederman], Alzheimer’s, jealousy, “oppositional” disorder, borderline states, assorted neurological diseases, sleep and mood disorders and whatever else would stick to the wall.

Like the doctors who upheld the “long-term safety and effectiveness of risperidone for severe disruptive behaviors in children,” on the basis of a one-year study in The Journal of the American Academy of Child and Adolescent Psychiatry in 2005.

How else could a drug known to cause diabetes, obesity, breasts in men, lactation in women and the very tardive dyskinesia it was supposed to prevent be a first choice drug in state formularies and on Medicaid protocols?

Given to children?

How did it become a preferred nursing home treatment–Taylor Park Nursing and Rehabilitation Center resident Bruce Bowman in Rhinelander, WI died last June after being put on Risperdal reports the Milwaukee Journal Sentinel–despite a warning label that says it increases death in elderly patients with dementia-related psychosis?

Nor did the FDA’s why-hold-up-a-drug-just-because-it’s-dangerous attitude hurt.

In 2007, it approved Risperdal for adolescents 13-17 with schizophrenia and children and adolescents 10-17 with “short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder” on the basis of two six to eight week studies.
Barely long enough to need validated parking.

In fact the FDA was surprised when a panel of drug experts called together in November unanimously rejected its routine safety monitoring for Risperdal and related drugs for children out of hand.

“I’m a little puzzled about the statement that the label is inadequate,” said Dr. Thomas Laughren, director of the agency’s division of psychiatry products according to the New York Times. “I’m anxious to hear what more we can do.”

How about not approving a drug in the first place?

MARTHA ROSENBERG is a columnist/cartoonist who writes about public health. She 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).

February 21, 2018
Ajamu Baraka
Venezuela: Revenge of the Mad-Dog Empire
Edward Hunt
Treating North Korea Rough
Binoy Kampmark
Meddling for Empire: the CIA Comes Clean
Ron Jacobs
Stamping Out Hunger
Ammar Kourany – Martha Myers
So, You Think You Are My Partner? International NGOs and National NGOs, Costs of Asymmetrical Relationships
Michael Welton
1980s: From Star Wars to the End of the Cold War
Judith Deutsch
Finkelstein’s on Gaza: Who or What Has a Right to Exist? 
Kevin Zeese - Margaret Flowers
War Preparations on Venezuela as Election Nears
Wilfred Burchett
Vietnam Will Win: Military Realities
Steve Early
Refinery Safety Campaign Frays Blue-Green Alliance
Ali Mohsin
Muslims Face Increasing Discrimination, State Surveillance Under Trump
Julian Vigo
UK Mass Digital Surveillance Regime Ruled Illegal
Peter Crowley
Revisiting ‘Make America Great Again’
Andrew Stewart
Black Panther: Afrofuturism Gets a Superb Film, Marvel Grows Up and I Don’t Know How to Review It
CounterPunch News Service
A Call to Celebrate 2018 as the Year of William Edward Burghardt Du Bois by the Saturday Free School
February 20, 2018
Nick Pemberton
The Gun Violence the Media Shows Us and the State Violence They Don’t
John Eskow
Sympathy for the Drivel: On the Vocabulary of President Nitwit
John Steppling
Trump, Putin, and Nikolas Cruz Walk Into a Bar…
John W. Whitehead
America’s Cult of Violence Turns Deadly
Ishmael Reed
Charles F. Harris: He Popularized Black History
Will Podmore
Paying the Price: the TUC and Brexit
George Burchett
Plumpes Denken: Crude thinking
Binoy Kampmark
The Caring Profession: Peacekeeping, Blue Helmets and Sexual Abuse
Lawrence Wittner
The Trump Administration’s War on Workers
David Swanson
The Question of Sanctions: South Africa and Palestine
Walter Clemens
Murderers in High Places
Dean Baker
How Does the Washington Post Know that Trump’s Plan Really “Aims” to Pump $1.5 Trillion Into Infrastructure Projects?
February 19, 2018
Rob Urie
Mueller, Russia and Oil Politics
Richard Moser
Mueller the Politician
Robert Hunziker
There Is No Time Left
Nino Pagliccia
Venezuela Decides to Hold Presidential Elections, the Opposition Chooses to Boycott Democracy
Daniel Warner
Parkland Florida: Revisiting Michael Fields
Sheldon Richman
‘Peace Through Strength’ is a Racket
Wilfred Burchett
Vietnam Will Win: Taking on the Pentagon
Patrick Cockburn
People Care More About the OXFAM Scandal Than the Cholera Epidemic
Ted Rall
On Gun Violence and Control, a Political Gordian Knot
Binoy Kampmark
Making Mugs of Voters: Mueller’s Russia Indictments
Dave Lindorff
Mass Killers Abetted by Nutjobs
Myles Hoenig
A Response to David Axelrod
Colin Todhunter
The Royal Society and the GMO-Agrochemical Sector
Cesar Chelala
A Student’s Message to Politicians about the Florida Massacre
Weekend Edition
February 16, 2018
Friday - Sunday
Jeffrey St. Clair
American Carnage
Paul Street
Michael Wolff, Class Rule, and the Madness of King Don
Andrew Levine
Had Hillary Won: What Now?
David Rosen
Donald Trump’s Pathetic Sex Life
FacebookTwitterGoogle+RedditEmail