Big Pharma Gone Wild
By Martha Rosenberg, AlterNet
February 3, 2009
The e-mail did not beat around the bush.
"The rationale of this center," Christine Cote,
vice president of Janssen's Medical Affairs, wrote 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."
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, Tenn., 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 U.S. patent expired in 2008!
Risperdal (risperidone), an atypical
anti-psychotic, 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
percent) and autism-related irritability in children 5 to 16 years old
(less than 1 percent of kids) becoming the seventh best-selling
pharmaceutical in the world in 2007?
Of course, some of Risperdal's success came
from the award-winning "Living Nightmares" campaign by London 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 Risperdal/risperdone 13 times hurt. Credit was available
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 despite a warning label that says it increases death in
elderly patients with dementia-related psychosis? Bruce Bowman, a
resident of Taylor Park Nursing and Rehabilitation Center in
Rhinelander, Wis., died last June after being put on Risperdal, reports
the Milwaukee Journal Sentinel.
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
In fact, the FDA was surprised when a panel of
drug experts in November unanimously rejected out of hand its routine
safety monitoring for Risperdal and related drugs for children.
"Iím 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. "Iím anxious to hear what more we can do."
How about not approving a drug in the first
Martha Rosenberg is a columnist and
cartoonist who frequently writes about the impact of the pharmaceutical,
food and gun industries on public health. A former medical copywriter,
her work has appeared in the Boston Globe, San Francisco Chronicle, Los
Angeles Times and Chicago Tribune, as well as on the BBC and in the
original National Lampoon.
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