FacebookTwitterGoogle+RedditEmail

Fragile: Handle with Risperdal

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).

December 13, 2018
John Davis
What World Do We Seek?
Subhankar Banerjee
Biological Annihilation: a Planet in Loss Mode
Lawrence Davidson
What the Attack on Marc Lamont Hill Tells Us
James McEnteer
Breathless
Ramzy Baroud
The Real Face of Justin Trudeau: Are Palestinians Canada’s new Jews?
Dean Baker
Pelosi Would Sabotage the Progressive Agenda With a Pay-Go Rule
Elliot Sperber
Understanding the Yellow Vests Movement Through Basic Color Theory 
Rivera Sun
The End of the NRA? Business Magazines Tell Activists: The Strategy is Working
Kevin Zeese - Margaret Flowers
Historic Opportunity to Transform Trade
December 12, 2018
Arshad Khan
War, Anniversaries and Lessons Never Learned
Paul Street
Blacking Out the Yellow Vests on Cable News: Corporate Media Doing its Job
Kenneth Surin
The Brexit Shambles Rambles On
David Schultz
Stacking the Deck Against Democracy in Wisconsin
Steve Early
The Housing Affordability Crisis and What Millennials Can do About It
George Ochenski
Collaboration Failure: Trump Trashes Sage Grouse Protections
Rob Seimetz
Bringing a Life Into a Dying World: A Letter From a Father to His Unborn Son
Michael Howard
PETA and the ‘S’-Word
John Kendall Hawkins
Good Panopt, Bad Panopt: Does It Make A Difference?
Kim C. Domenico
Redeeming Utopia: a Meditation On An Essay by Ursula LeGuin
Binoy Kampmark
Exhuming Franco: Spain’s Immemorial Divisions
ADRIAN KUZMINSKI
Democratizing Money
Laura Finley
Congress Must Reauthorize VAWA
December 11, 2018
Eric Draitser
AFRICOM: A Neocolonial Occupation Force?
Sheldon Richman
War Over Ukraine?
Louis Proyect
Why World War II, Not the New Deal, Ended the Great Depression
Howard Lisnoff
Police Violence and Mass Policing in the U.S.
Mark Ashwill
A “Patriotic” Education Study Abroad Program in Viet Nam: God Bless America, Right or Wrong!
Laura Flanders
HUD Official to Move into Public Housing?
Nino Pagliccia
Resistance is Not Terrorism
Matthew Johnson
See No Evil, See No Good: The Truth Is Not Black and White
Maria Paez Victor
How Reuters Slandered Venezuela’s Social Benefits Card
December 10, 2018
Jacques R. Pauwels
Foreign Interventions in Revolutionary Russia
Richard Klin
The Disasters of War
Katie Fite
Rebranding Bundy
Gary Olson
A Few Thoughts on Politics and Personal Identity
Patrick Cockburn
Brexit Britain’s Crisis of Self-Confidence Will Only End in Tears and Rising Nationalism
Andrew Moss
Undocumented Citizen
Dean Baker
Trump and China: Going With Patent Holders Against Workers
Lawrence Wittner
Reviving the Nuclear Disarmament Movement: a Practical Proposal
Dan Siegel
Thoughts on the 2018 Elections and Beyond
Thomas Knapp
Election 2020: I Can Smell the Dumpster Fires Already
Weekend Edition
December 07, 2018
Friday - Sunday
Steve Hendricks
What If We Just Buy Off Big Fossil Fuel? A Novel Plan to Mitigate the Climate Calamity
Jeffrey St. Clair
Cancer as Weapon: Poppy Bush’s Radioactive War on Iraq
Paul Street
The McCain and Bush Death Tours: Establishment Rituals in How to be a Proper Ruler
Jason Hirthler
Laws of the Jungle: The Free Market and the Continuity of Change
FacebookTwitterGoogle+RedditEmail