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
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 "Risperdal" 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.
Risperdal's US patent expired in 2008!
atypical antipsychotic, may have contributed to the deaths of 31
children since 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 percent of the population--bipolar disorder--
irritability in children 5-16--less than 1 percent of kids--becoming
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
histories to "own the relapse/prevention space" as art director
John Timney put it.
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
medical education courses
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,
grandiose" "psychopathologies" [per Biederman],
"oppositional" disorder, borderline states, assorted neurological
sleep and mood disorders and
whatever else would stick to the wall.
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
of Child and Adolescent Psychiatry in 2005. Hello?
How else could
a drug known to cause diabetes, obesity, breasts in men, lactation in women and
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
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.
little puzzled about the statement that the label is inadequate," said
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?