Risperdal - US Attorney: J&J paid kickbacks to hike sales of schizophrenia drug to nursing home patients

[Guest guest]

posting here because this is part of the whole conflict of interest that

goes on - if they do it with drugs, they also do it with vaccines

Sheri

" Such drugs leave patients sedated — in what's called a chemical

restraint — most of the time, making them easier to manage, particularly

in nursing homes with insufficient staff. "

" ...Omnicare pharmacists reviewed the charts of nursing home

patients at least once a month, then made recommendations to physicians

on what drugs patients should be getting. "

(

http://www.courant.com/business/nationworld/wire/sns-ap-us-jj-kickback-charges,0,847770.story

)

Courant.com

US Attorney: J & J paid kickbacks to hike sales of

schizophrenia drug to nursing home patientsLINDA A.

JOHNSON

AP Business Writer

3:39 PM EST, January 15, 2010

TRENTON, N.J. (AP) — Federal prosecutors said Friday that health care

giant & paid tens of millions of dollars in kickbacks

so nursing homes would put more patients on its blockbuster schizophrenia

medicine and other drugs.

In a complaint filed Friday, prosecutors said J & J paid rebates and

other forms of kickbacks to Omnicare Inc., the country's biggest

dispenser of prescription drugs in nursing homes. Prosecutors allege

Omnicare pharmacists then recommended that nursing home patients with

signs of Alzheimer's disease be put on the powerful schizophrenia drug

Risperdal, which was later found to increase risk of death in the

elderly.

The allegations are in a complaint filed by the U.S. Attorney in Boston,

whose office has joined two whistle-blower cases. One was filed in 2003

by a former Omnicare pharmacist in Chicago, Bernard Lisitza, who alleges

he was fired after he challenged the Risperdal kickbacks and other

improper practices at the company. The other was filed by former Omnicare

financial analyst Kammerer in 2005, after he resigned from the

company.

" Kickbacks in the nursing home pharmacy context are particularly

nefarious because they can result in excessive prescribing of strong

drugs to patients who have little or no control over the medical care

they are receiving, " U.S. Attorney Carmen Ortiz said in a statement.

" Nursing home doctors should be able to rely on the integrity of the

recommendations they receive from pharmacists, and those recommendations

should not be a product of money that a drug company is paying to the

pharmacy. "

& , based in New Brunswick, N.J., said in a statement

it is reviewing the complaint and " will address the government's

lawsuit in court. We believe airing the facts will confirm that our

conduct, including rebating programs like those the government now

challenges, was lawful and appropriate. We look forward to the

opportunity to present our evidence in court. "

Ortiz's office is seeking triple damages, restitution and other penalties

under the federal False Claims Act and other laws. The damages would be

based on the amount of false claims charged to Medicaid, which paid for

about two-thirds of the claims Omnicare submitted for J & J drugs —

possibly hundreds of millions of dollars.

Separately, & said Friday it's expanding a recall of

over-the-counter medications, due to a moldy smell that has made users

sick, from Tylenol to some other brands.

In afternoon trading, & shares fell 91 cents to

$64.20.

" The government's complaint paints a sordid picture of J & J

payola driving sales of drugs in nursing homes, " said Behn,

a Chicago attorney who filed the whistle-blower complaint in October 2003

on behalf of Lisitza. " Pharmacists are trusted professionals. There

can be zero tolerance for kickbacks. "

The government's motion to intervene in the case was approved last

month.

Its complaint alleges the scheme went on from 1999 through 2004, a period

when J & J's sales of drugs through Omnicare jumped from about $100

million to more than $280 million. More than one-third of that was sales

of Risperdal; the other drugs were pain relievers Duragesic and Ultram

and an antibiotic, Levaquin.

Soon after that, the Food and Drug Administration required Risperdal to

be sold with its most severe, " black box " warning, stating that

giving Risperdal and similar drugs to elderly patients with

dementia-related psychosis increased their risk of death. The warning

states the use of Risperdal is not approved for patients with

dementia-related psychosis — schizophrenia and other mental illnesses

causing delusions and hallucinations.

Yet an Archives of Internal Medicine study published Monday covering

nearly 17,000 nursing home residents around the country found one-third

of those getting antipsychotic medications in 2006 didn't have

appropriate symptoms. In addition, nursing homes that already had the

highest rates of antipsychotic medication use were much more likely to

give those drugs to new patients as they arrived. Such drugs leave

patients sedated — in what's called a chemical restraint — most of the

time, making them easier to manage, particularly in nursing homes with

insufficient staff.

Risperdal brought J & J $1.73 billion in sales in the first nine months

of 2009, nearly 4 percent of its $45.3 billion in total revenue. Sales

have been falling recently due to generic competition to one

version.

Last November, Omnicare agreed to a $90 million settlement with the

federal government and numerous states to resolve its liability in the

case, according to Ortiz.

The complaint states that & knew Omnicare pharmacists

reviewed the charts of nursing home patients at least once a month, then

made recommendations to physicians on what drugs patients should be

getting. The complaint alleges J & J knew physicians accepted those

recommendations more than 80 percent of the time and states that J & J

considered those pharmacists an " extension of (J & J's)

salesforce. "

The government alleges Omnicare agreed to operate " Active

Intervention Programs " to increase prescribing of J & J drugs, and

that & paid for that with so-called

" grants " and " educational funding, " and other methods

that allowed it to evade requirements to pay government health programs

equivalent rebates.

Under one of the programs, called the " Risperdal Initiative, "

physicians were persuaded to prescribe Risperdal to patients with

" behavioral disturbances associated with dementia, " the

government alleges.

Besides & , the complaint names two of its

subsidiaries as defendants: Ortho-McNeil-Janssen Pharmaceuticals Inc.,

which makes and sells Risperdal and other drugs, and &

Health Care Systems Inc., which entered into contracts with

Omnicare.

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