Janssen Admits it Minimized Risk of Risperdal
Janssen finally admits it "misled" or "minimized the risks"
(LIED AND COVERED UP) of many serious health risks of its neuroleptic
Risperdal (risperidone) as a treatment for "schizophrenia". Risperdal has
already caused many cases of diabetes, heart problems, strokes and death (see
article below). Several other corporate drugpushers of neuroleptics and
antidepressants are also guilty of lying to the FDA, Health Canada, and
public--like GlaxoSmithKline re Paxil, Pfizer re Zoloft, Eli Lilly re Prozac,
and Wyeth re Effexor.
- Don Weitz
http://www.washingtonpost.com/wp-dyn/articles/A12138-2004Jul24.html
Maker of Schizophrenia Medicine Clarifies Risks
Associated Press
Sunday, July 25, 2004; Page A12
TRENTON, N.J., July 24 -- The maker of a popular medicine for schizophrenia has
notified doctors that it had minimized potentially fatal safety risks and had
made misleading claims about the drug in promotional materials.
Janssen Pharmaceutica Products LP sent a two-page letter to health care
professionals to clarify the risks of Risperdal, Carol Goodrich, a spokeswoman
for the Johnson & Johnson subsidiary, said on Saturday.
The letter stems from a directive issued last year by the Food and Drug
Administration, which told several makers of anti-psychotic drugs to update
their product labels.
Janssen complied in November 2003, but the FDA determined that the company's
promotional materials still minimized the risk of strokes, diabetes and other
potentially fatal complications. The agency also said Janssen made misleading
claims that the medication was safer in treating mental illness than similar
drugs.
The Miami Herald reported on Saturday that several boys in Florida developed
lactating breasts after taking Risperdal.
The drug, which is prescribed to more than 10 million people worldwide, was
cited in a federal lawsuit filed earlier this month by a doctor who contends
that children have been harmed and even killed by the misuse of drugs that he
blames on the aggressive marketing by drug manufacturers.
"The FDA did not think we had [initially] provided enough information, so that
is why further notification was done," Goodrich said.
Risperdal is the leading drug used to combat schizophrenia and other types of
psychotic disorders, bringing Janssen about $2.1 billion in annual sales. The
drug was first marketed about eight years ago.
© 2004 The Washington Post Company
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You may foward this in order to educate your friends.
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting openness and full disclosure
http://www.ahrp.org
FYI The Miami Herald reports (below) that in a letter to doctors,
Janssen Pharmacia, manufacturer of the highly promoted drug, Risperdal
(risperidone), admitted "misleading doctors and other healthcare providers about
the safety of its product, minimizing potentially deadly side effects." As late
as Nov. 10, 2003, Janssen claimed Risperdal did not increase the risk of
diabetes among consumers--when the company knew the opposite was true.
"The drug, Risperdal, has been commonly prescribed to Florida children in state
care, including to a handful of boys who developed lactating breasts after
taking it."
Circuit Judge John A. Frusciante, said Risperdal continues to be used frequently
by doctors who treat children in state care. ''It is not uncommon,'' he said,
noting: "This whole psychotropic drug issue is a problem for us. It's a very
scary area to be in, because we know medication can be a tremendous help for a
number of children. But we also know that there are risks to the children who
are taking these medications.''
In what appears to be a blindfolded canoe ride down the rapids, Illinois public
officials have adopted a disastrous plan mandating mental health screening tests
for all children--including those still in the womb--thus, pregnant women are to
be swept up against their will as well.
The screening, and registering those deemed to have a "mental disorder"
will--without a doubt--be followed by the prescribing of tons of psychotropic
drugs such as Risperdal, Zyprexa (olanzapine) Paxil (seroxat), Prozac, etc. As
one savvy woman who testified against the Illinois plan stated:
The recommendation to "explore strategies for maximizing the purchase of
psychotropic drugs.at discounted prices" seems to give us an incredible look at
where this task force thinks Illinois children are headed at a bargain rate.
See: Karen Hayes, Illinois' associate director of Concerned Women for America (CWA),
the nation's largest public policy women's organization. GUEST OPINION: Maybe
legislators should be mentally evaluated, too Friday, July 23, 2004
http://www.illinoisleader.com/opinion/opinionview.asp?c=17908
The Illinois plan was adopted just as the Kaiser Commission on Medicaid & the
Uninsured reported that 143,000 children have been cut out from health insurance
because of cost containment. Half of the discarded children live in Texas-the
others in New York, Maryland...
http://www.reuters.com/newsArticle.jhtml?type=domesticNews&storyID=5761395
Of special significance: Texas is the birthplace of the Texas Medication
Algorithm Project (TMAP) for mental health. TMAP is the psychotropic drug
marketing scheme created by a cartel of drug manufacturers and a group of
influential psychiatrists at the University of Texas, who happen to be paid
consultants to those companies.
TMAP recommendations are a sure fire sales promotion scheme for atypical
antipsychotics and SSRI antidepressants. See:
http://psychrights.org/Articles/NYTMakingDrugsShapingtheRules.htm
The Robert Woods Johnson Foundation (RWJF), which funded the TMAP start-up, is
associated with Johnson & Johnson and Janssen Pharmaceutica. Janssen is the
manufacturer of Risperdal, a drug promoted by TMAP as a first-line treatment for
schizophrenia. See, the Florida court decision about the hazards of Risperdal.
The Robert Wood Johnson Foundation provided funding for the exportation of TMAP
to other states and provided funding for the start-up of the current Illinois
Children's Mental Health Partnership screening initiative.
http://128.248.232.90/archives/mchb/amchp2004/e7/transcripts/session19b.htm
The Illinois Children's project recommends that the screening and medication
project should be funded with tax dollars from the federal Substance Abuse
Mental Health Services Agency (SAMHSA) and Medicaid.
http://64.233.161.104/search?q=cache:MqdeybSeZT0J:www.isbe.state.il.us/iicc/pdf/icmhp_preliminary_plan.pdf+22illinois+children%27s+mental+health+partnership%22+%2B+samhsa&hl=en&ie=UTF-8
TMAP is also the catalyst for the President's New Freedom Commission Report
which recommends screening the entire US population for mental illness.
http://bmj.bmjjournals.com/cgi/content/full/328/7435/306
Screening for illness is always a prelude for prescribing treatment
interventions--drugs and other treatments--that increase costs (for consumers) /
increase profits for the suppliers--and often have disastrous results for those
treated.
Contact: Vera Hassner Sharav Tel: 212-595-8974 e-mail:
veracare@ahrp.org
http://www.reuters.com/newsArticle.jhtml?type=domesticNews&storyID=5761395
States Cut Health Insurance for 145,000 Kids Fri Jul
23, 2004 05:15 PM ET
By Joan Gralla NEW YORK (Reuters) - Some 145,000 poor children were dropped from
a U.S. federal-state health insurance plan in the second half of 2003, with more
than half the cuts made by Texas, a health-care research foundation said on
Friday.
"The drop in (the) State Children's Health Insurance Program is a major setback
when millions of uninsured children are eligible but not yet enrolled," said
Diane Rowland, executive director of the Kaiser Commission on Medicaid and the
Uninsured.
Net enrollment in the program, which mainly benefits working families, fell last
year for the first time since it was launched in 1998, the Washington,
D.C.-based Kaiser Commission said in a report.
In many cases, states made the cuts because a weak economy left them with huge
budget deficits. Along with Texas, two other states -- Maryland and New York --
accounted for most of the cuts in the program last year. The two eastern states
each cut 23,000 low-income children, the report said.
A total of 11 states sliced enrollment, with "noteworthy" cuts made in Florida,
Colorado and South Carolina, the report said.
The number of needy children who got this health insurance peaked in June 2003
at 3.964 million. Though 37 states added children to the program in the second
half of last year, the total number still fell by 37,000 children, the report
added.
In some cases, the number of children fell because they were shifted to
Medicaid, which provides health care for more impoverished children and adults,
the report noted.
Still, that was not the case in some of the states that clipped enrollment,
including Texas. That state stopped covering "a broad range of services,"
including glasses, eye and teeth exams, and services by chiropractors, hospices
and skilled nursing centers, the report said.
The health insurance for children remains popular, the report said, noting it
was protected from early rounds of cost cuts by its "relatively low cost per
enrollee."
The program cost the federal government $3.7 billion and the states $1.6 billion
in fiscal 2002, the most recent data available, according to Kaiser Commission
spokesman Rakesh Singh.
"Typically, kids are fairly cheap to provide health insurance for," he said.
C Reuters 2004. All rights reserved.
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http://www.miami.com/mld/miamiherald/9231611.htm?template=contentModules/printstory.jsp
MIAMI HERALD / CHILD WELFARE
Maker of drug admits hiding its risks
Posted on Sat, Jul. 24, 2004
BY CAROL MARBIN MILLER cmarbin@herald.com
The maker of a billion-dollar antipsychotic medication has acknowledged
misleading doctors and other healthcare providers about the safety of its
product, minimizing potentially deadly side effects.
The drug, Risperdal, has been commonly prescribed to Florida children in state
care, including to a handful of boys who developed lactating breasts after
taking it.
On Wednesday, drug maker Janssen Pharmaceutica wrote a two-page letter to
doctors, warning them that the company, in promotional material, had ''minimized
potentially fatal risks, and made misleading claims'' that the medication was
more safe in treating mental illness than other drugs in the same category.
Most physicians received the letter Friday.
Risperdal is the leading drug used to combat schizophrenia and other types of
psychotic disorders, earning Janssen about $2.1 billion in annual sales. The
drug was first marketed about eight years ago, and is prescribed to more than 10
million people worldwide.
The ''important correction of drug information'' came shortly after federal
regulators had accused Janssen of ''disseminating'' advertising and marketing
material that was ``false or misleading.''
A letter from Janssen to doctors, dated Nov. 10, 2003, claimed Risperdal did not
increase the risk of diabetes among consumers compared with other similar drugs,
called neuroleptics or antipsychotics.
But an April 2004 letter from the U.S. Department of Health and Human Services
to Janssen asserts quite the contrary. Research indicated ''an increased risk of
hyperglycemia-related adverse effects and diabetes with Risperdal,'' the letter
stated.
A TROUBLED HISTORY
In 2001, The Herald published a series of stories about the common use of
Risperdal among children in state care. Child-welfare advocates said the drug
routinely was being used by foster care providers as a ''chemical restraint'' on
children whose unruly behavior was a frustration to caretakers.
''I had clients who were displaying severe side effects, and I tried to alert
the Department of Children & Families both as to the local problem and the
growing national concern about a range of psychotropic medications, Risperdal
and other antipsychotics in particular,'' said Coral Springs attorney and
children's advocate Andrea Moore.
''They listened, but they did not hear me,'' Moore added.
Broward Circuit Judge John A. Frusciante, who must approve requests from doctors
before they can prescribe mind-altering drugs to children whose cases he
oversees, said Risperdal continues to be used frequently by doctors who treat
children in state care.
''It is not uncommon,'' Frusciante said.
''This whole psychotropic drug issue is a problem for us,'' Frusciante said.
``It's a very scary area to be in, because we know medication can be a
tremendous help for a number of children. But we also know that there are risks
to the children who are taking these medications.''
Friday, DCF officials told The Herald they would review the new material and ask
doctors who care for foster children to re-evaluate their medication options.
''We will make this information available to all our districts, program
supervisors, community-based care agencies and partners,'' said DCF spokesman
Bill Spann. ``In addition, we will provide this information to all the
physicians who care for the children in foster care, and ask them to review the
cases of any children who are on the drug.
''We will ask them to take the appropriate action,'' Spann said.
ONE IN THREE TREATED The state Agency for Health Care Administration, which pays
the drug bill for most children in state care, as well as needy children who are
insured by Medicaid, could not say Friday how many Florida Medicaid recipients
are being administered the drug.
In 2001, after The Herald's series, DCF reviewed the records of most foster
children. Records showed about about one in three foster children taking a
powerful mood-altering drug. Many were taking untested combinations, or
''cocktails,'' of the drugs.
Infants and toddlers were being given psychiatric drugs, according to a 2003
study by the Florida Statewide Advocacy Council.
Antoinette R. Appel, a Plantation neuropsychologist, studied the records of
about 50 South Florida foster children who had been prescribed Risperdal.
She said many of the children developed severe side-effects, including obesity,
lethargy, lack of concentration, hormonal disorders and the inappropriate
development of secondary sexual characteristics, such as lactating breasts in
boys or young girls.
Carolyn Salisbury, associate director of the University of Miami's Children &
Youth Law Clinic, has pleaded with child welfare authorities for about five
years to curtail the widespread use of mood-altering drugs among foster kids,
who often complain the drugs make them more ill.
VICTORY IN COURT One of the clinic's most high-profile clients, identified in
court papers as M.W., won a Florida Supreme Court ruling that child welfare
authorities cannot lock up foster kids in psychiatric hospitals without a
hearing. M.W. had developed lactating breasts after doctors forced him to take
Risperdal, court records show.
One of Salisbury's clients, a 15-year-old girl, begged her to prevent the child
welfare agency from forcing her to take Risperdal, Salisbury said. The girl had
become obese and suffered from dramatic mood swings, alternating between feeling
agitated or very depressed.
''I always object to my foster child clients being placed on Risperdal . . .,''
Salisbury said. ``However, DCF continues to place children in their care on the
drug, even though DCF knows full well the horrible side effects foster children
continue to suffer on this drug.''
C 2004 Herald.com _______
Last Updated on
07/26/04
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