Janssen Admits Hiding Risperdal Risks / TMAP & Illinois Mental Health Screening

Janssen Pharma Admits Hiding Risperdal Drug Risks / TMAP & Illinois Mental Health Screening Plan

Sat, 24 Jul 2004

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 are adopting 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 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

The Illinois plan was being finalized 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.

The Illinois Children’s Mental Health Partnership (ICMHP) preliminary plan 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. (retrieve pdf of draft plan from http://www.isbe.state.il.us/iicc/ or view google cache)

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/328/7454/1458

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

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 HERLAD / CHILD WELFARE
Maker of drug admits hiding its risks
Posted on Sat, Jul. 24, 2004

BY CAROL MARBIN MILLER

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

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