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, Tennessee, 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 Massachusetts General, 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 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, 2.5 percen; tand autism-related irritability in children 5-16, less
than 1 percent of kids, becoming the seventh
best selling medication 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. Hello?
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, Wisconsin, 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, out of hand, its routine safety monitoring for Risperdal and related
drugs for children.
�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 Chicago columnist/cartoonist who writes
about public health. She may be reached at martharosenberg@sbcglobal.net.