Johnson & Johnson and Omnicare Face Lawsuits over Risperdal in ...

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We represent EVERYONE in need anywhere in Washington - Minor and Major Injuries Experienced trial attorneys that will fight for your right to recover compensation FREE Case Review and we only get paid if you get paid If you had any reservations as to the length a giant pharmaceutical company will go to make a profit then this story may be the one that convinces you.

The Attorney General of Massachusetts, Martha Coakley’s office joined a federal lawsuit yesterday against Johnson & Johnson. The suit contends that, beginning as early as 1999, J&J paid tens of millions of dollars in kickbacks to national nursing home medical products provider Omnicare to get its drugs, especially the powerful antipsychotic Risperdal, prescribed in nursing homes.

This comes a year after the generic version of Risperdal was approved by the Food and Drug Administration (FDA). Officials J&J wrote in a business plan as recently as just a few months ago, “The geriatric market represents Risperdal’s second wave of growth. The aging population will continue to drive market growth well into the next century.”

This means that J&J intended to treat dementia patients with Risperdal even after learning about the side effects.

You see, the problem is that FDA specifically warned that Risperdal considerably raises a dementia patient’s chances of death. J&J might have intended to use early death of senior citizens with dementia as an engine for profit.

Risperdal

Risperdal is an antipsychotic drug that is used to treat schizophrenia. It quells symptoms of the mental disorder. In the mid 90’s it was also touted as a go-to drug for a myriad of mental disorders, but was severely reigned in by the FDA by the late 90’s because the side effects can be pretty severe. It is used for more mild conditions such as bi-polar disorder and over-aggression in autistic children.

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Johnson & Johnson Internal Documents Reveal Unsavory and Potentially Illegal ...
The multi-billion dollar drug company, Johnson & Johnson (J&J), has come under fire for allegedly violating the rules in their marketing of Risperdal,

J&J relied on geriatrics to grow Risperdal
"Aggressive expansion of Risperdal use in other indications is therefore mandatory." Based on its review of the documents, Bloomberg reports that the

CORRECT: Omnicare 4Q Earnings Triple On Lower Costs; Rev Down
Johnson (JNJ) paid Omnicare "tens of millions of dollars in kickbacks" to increase sales of drugs including blockbuster antipsychotic Risperdal.

US Seeks More Information About J&J Antipsychotic Marketing
J&J has said it's cooperating with government requests for documents and witnesses related to Risperdal. J&J hasn't disclosed the exact nature of the probes

Omnicare 4Q profit jumps as legal costs decrease
tens of millions in kickbacks to Omnicare so more nursing home patients would be prescribed drugs including Risperdal, a treatment for schizophrenia.

3 Chances with Pimavanserin
Data from this phase IIb trial demonstrated that the addition of pimavanserin (20mg) to low-dose Risperdal (2mg) had several positive outcomes,

Smackdown! Why We Need More Head-to-Head Drug Trials
four new antipsychotics used to treat schizophrenia—Risperdal, Seroquel, Geodon, and Zyprexa—with a 50-year-old generic drug called perphenazine.

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Omnicare 4Q profit jumps as legal costs decrease

COVINGTON, Ky. — Omnicare Inc., which dispenses drugs to nursing homes and long-term care facilities, said Thursday its profit almost tripled in the fourth quarter after it resolved allegations it paid kickbacks to nursing homes, and received money for buying and recommending drugs.

In June, Omnicare agreed to pay $98 million to settle the investigation. The terms were completed in November. The Justice Department said Omnicare paid $50 million to a pair of Atlanta nursing homes to gain their business, while also asking for and getting kickbacks from two drug companies for recommending their products.

Some of those kickbacks involved drugmaker Johnson & Johnson. Federal prosecutors charged Johnson & Johnson with paying tens of millions in kickbacks to Omnicare so more nursing home patients would be prescribed drugs including Risperdal, a treatment for schizophrenia.

Omnicare did not acknowledge any wrongdoing as part of the settlement.

In the fourth quarter, the company said its profit rose to $80 million, or 68 cents per share, from $27.6 million, or 24 cents per share, a year earlier. Omnicare said it earned 74 cents per share from continuing operations, but that includes a tax benefit of 11 cents per share. Its revenue fell 2 percent to $1.54 billion from $1.57 billion

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Analyst Report ) are moving forward with a 3-pronged strategy for pimavanserin. Acadia plans a phase III trial in Parkinson’s disease psychosis (PDP) and a phase II feasibility study in Alzheimer’s disease psychosis (ADP). Biovail plans a phase III trial with pimavanserin as an adjunctive therapy for schizophrenia. All three programs should be up and running by the third quarter 2010.

Management has made a number of changes to the planned third phase III program with pimavanserin PDP that we believe will aid in the success of the trial.

Firstly, the trial will test only 40mg pimavanserin vs. placebo in a 1:1 randomization. We remind investors that the previous program had 3 arms at a 2:1 randomization (10mg and 40m vs. placebo). Reducing the randomization to 1:1 should help reduce the perception that patients believe they are on drug and reduce the statistic hurdle that is required to meet significance (to p<0.05).

Second, management will conduct fewer patient visits during the active dosing portion of the trial.  This will limit the interaction between the Parkinson’s patient and the clinician, which may have resulted in improved perception in disease psychosis during the first phase III trial. For example, the patients in the first trial received a significant step-up in quality of care relative to non-participating patients.

Smackdown! Why We Need More Head-to-Head Drug Trials

Is so damning. It turns out that fewer than two thirds of studies fall into the comparative-effectiveness category, and the reason, according to the paper’s authors, is chicanery on the part of drug companies.

The authors of the paper—Michael Hochman of the Keck School of Medicine of the University of Southern California, and Danny McCormick of Harvard Medical School/Cambridge Health Alliance—looked at 328 clinical trials that were recently published in prestigious journals. Two thirds of the studies were “devoted to the development of new therapies,” says Hochman, “not helping doctors use existing therapies more effectively.” Only two of the 328 studies bothered to examine which drugs were both effective and cheap—even though part of the reason the White House loves comparative effectiveness is its potential to cut back on health-care costs by making medicine more efficient. Instead, most of the studies compared new, expensive drugs to either no treatment or a placebo.