CCHR International » Omnicare

Cause for alarm: Antipsychotic drugs for nursing home patients

cchrint — Tue, 31 May 2011 21:17:06 +0000

CNN
By Daniel R. Levinson, Special to CNN
May 31, 2011

Daniel Levinson, inspector general for the OIG in the Department of Health and Human Services.

When a loved one moves into a nursing home, the support of family and friends is particularly important. This is especially true when the nursing home patient has dementia and can’t adequately advocate on his or her own behalf.

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.

Frequently, they are prescribed in ways that don’t qualify as medically accepted for Medicare coverage. In addition, the drugs were predominately prescribed for uses that are not approved by the Food and Drug Administration.

But the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia.

This is precisely the population that faces an increased risk of death when using this class of drugs, according to the FDA. That’s why the agency puts its strongest safety warning, called a “black box warning” on these antipsychotic drugs, cautioning about the risk of death when taken by elderly people with dementia.

The report didn’t investigate why patients with dementia are prescribed antipsychotic drugs so often. But a series of lawsuits and settlements that my office helped bring about suggests that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years.

Another view: In defense of antipsychotics for dementia

The study began a few years ago, when a member of Congress questioned how many nursing home residents received a class of antipsychotic drugs introduced in the 1990s, among them risperidone and olanzapine. These drugs are known as “atypical” or “second generation” antipsychotics. They replaced the antipsychotic drugs introduced in the 1950s and 1960s to treat schizophrenia — and, incidentially, are far costlier.

The report found about 305,000 nursing home residents (about 14%) had Medicare claims for atypical antipsychotic drugs. Of these, about one in five residents was prescribed these antipsychotics in a way that violated government standards for their use. For example, residents were on a drug for too long, or at too high a dose.

Another finding: A little more than half the antipsychotic drug claims for which Medicare paid should not have been covered. Why? The claimed drugs were not used for medically accepted reasons or there were no records the drugs were actually provided.

To be clear: Most physicians and nursing homes dispense antipsychotic drugs with the best interests of patients in mind. Physicians can use their medical judgment to prescribe drugs for uses unapproved by the FDA, and also to patients for whom the boxed warning applies. Ideally, however, doctors who prescribe in such ways first determine that the benefits outweigh the risks.

Yet it remains a concern that so many elderly nursing home residents with dementia are prescribed antipsychotics. And, unfortunately, examples abound of companies’ improper promotion of these drugs.

Government investigations of Bristol-Myers Squibb, AstraZeneca and Pfizer found that they improperly promoted their antipsychotic drugs for unapproved uses.

Federal prosecution is pending against Johnson & Johnson for allegedly paying millions of dollars in kickbacks to induce Omnicare, the nation’s largest long-term care pharmacy, to recommend the use of Risperdal in treating nursing home patients, many of whom had dementia.

And Eli Lilly pleaded guilty to criminal charges associated with illegally marketing its drug Zyprexa, including to doctors who treat elderly nursing home patients.

Pharmaceutical companies have paid billions to resolve civil and criminal liabilities under federal health and safety laws. But money can’t adequately compensate for corporate campaigns that could put vulnerable, elderly patients at risk.

How do we solve this problem? There’s plenty to do.

Family members of nursing home residents must learn about their loved ones’ medications, the reasons for their use, proper dosages and possible side effects.

Nursing homes and pharmacies that serve the elderly must keep the best interests of the patient in mind when dispensing pharmaceuticals and not base the decision on the improper influence of drug companies.

Doctors, too, should rely on their best medical judgments and engage in an especially careful analysis when prescribing drugs for off-label use.

Government must combat illegal off-label promotion of these powerful and potentially lethal drugs and uphold nursing home safety standards.

And drug companies should follow the laws, and refrain from promoting drugs for unapproved uses — or paying kickbacks to influence doctors and institutions. About 46 million people are enrolled in Medicare. That will only grow as the huge baby boomer population retires. We cannot afford to leave unaddressed the urgent problem of antipsychotic drug use among elderly nursing home residents.

The opinions in this commentary are solely those of Daniel Levinson.

Read article here: http://www.cnn.com/2011/OPINION/05/31/levinson.nursing.home.drugs/

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Antipsychotic Drugs Called Hazardous for the Elderly

cchrint — Tue, 10 May 2011 03:57:23 +0000

The New York Times
By Gardiner Harris
May 9, 2011

Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, a government audit found.

More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the audit found, costing the program $116 million for those six months.

“Government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions,” Daniel R. Levinson, inspector general of the Department of Health and Human Services, wrote in announcing the audit results.

Mr. Levinson noted that such drugs — which include Risperdal, Zyprexa, Seroquel, Abilify and Geodon — are “potentially lethal” to many of the patients getting them and that some drug manufacturers illegally marketed their medicines for these uses “putting profits before safety.”

The audit is an unusual assessment by the government of whether doctors are treating Medicare patients appropriately in nursing homes. Mr. Levinson suggested that the government should collect information on the diagnoses given Medicare patients so that the government can assess whether the drugs prescribed to them are appropriate.

While common in the private sector, such basic oversight is unheard of in the Medicare program and would almost certainly be opposed by doctors’ groups and many in Congress who view government intrusions into the doctor-patient relationship as inappropriate. In response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers’ paying kickbacks to nursing homes to increase prescriptions for the medicines.

Omnicare Inc., a pharmacy chain for nursing homes, paid $98 million in November 2009 to settle accusations that it received kickbacks from Johnson & Johnson and other drug makers for antipsychotic prescriptions.

Medicare officials said that diagnosis information is not generally included with prescriptions so the government cannot assess in real time whether prescription payments are appropriate.

While the Food and Drug Administration has warned doctors that using antipsychotic drugs in elderly patients with dementia increases their risks of death, doctors continue the practice because they have few other good choices, said Dr. Daniel J. Carlat, editor in chief of The Carlat Psychiatry Report, a medical education newsletter for psychiatrists.

“Doctors want to maximize quality of life by treating the patient’s agitation even if that means the patient will die a bit sooner,” Dr. Carlat said.

The government auditors found that of the 2.1 million elderly patients in nursing homes during the first six months of 2007, 304,983 had at least one Medicare claim for an antipsychotic medicine. Nursing home residents received 20 percent of the 8.5 million claims for antipsychotic medicines for all Medicare beneficiaries at a cost of $309 million during those six months.

The auditors found that 83 percent of antipsychotic prescriptions for elderly nursing home residents were for uses not approved by federal drug regulators, and 88 percent were to treat patients with dementia — for whom the drugs can be lethal.

“These results are alarming,” said Senator Charles E. Grassley, Republican of Iowa, who asked for the audit. “Medicare officials need to pay attention.”

Federal rules require that any drugs that are paid for by the government be given only for uses that are approved either by the government or one of three independent drug usage encyclopedias. Auditors found that 51 percent, or 726,000 of 1.4 million claims, for antipsychotic medicines did not meet this criterion and were thus paid for by the government improperly.

Government rules also ban drugs that are used in excessive doses or duration, even if patients are found to have a condition for which the drug is appropriate. Auditors found that 22 percent, or 317,971 of 1.4 million claims, for antipsychotic medicines failed this standard.

Read article here: http://www.nytimes.com/2011/05/10/health/policy/10drug.html?_r=2

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Federal Judge & DOJ back lawsuit accusing Johnson & Johnson of illegal kickback scheme to push antipsychotic drugs on elderly

admin — Tue, 01 Mar 2011 19:42:44 +0000

AboutLawsuits.com

March 1, 2011

A federal judge has refused to toss out a whistleblower lawsuit backed by the Department of Justice (DOJ), which accuses Johnson & Johnson of involvement in an illegal kickback scheme to push their antipsychotic drugs on elderly nursing home residents that did not need them.

Johnson & Johnson sought to have claims brought by the DOJ, a number of whistleblowers and states dismissed, saying that what the plaintiffs are calling illegal kickbacks were completely legal rebates. However, U.S. District Judge Richard Stearns found that plaintiffs had sufficient evidence to go forward with the complaint.

Judge Stearns did remove several plaintiffs from the case, including the states of Nevada, Texas and Illinois, but allowed Kentucky, Indiana and Virginia to stay part of the lawsuit. Whistleblower David Kammerer was also removed from the lawsuit.

The DOJ filed a civil False Claims Act compliant against J&J on January 15, 2010, saying that the company paid millions to Omnicare, Inc. as kickbacks for selling Risperdal to nursing home patients.

In 2009, Omnicare settled charges brought against it by the government for allegedly paying kickbacks to nursing homes to prescribe the drug. At that time, the Justice department investigators indicated that the illegal nursing home drug kickbacks were hidden as data fees, education fees and as payments to attend Omnicare meetings.

According to the DOJ complaint against Johnson & Johnson, the drug maker paid $50 million to Omnicare between 1999 and 2004 to get it to prescribe Risperdal to elderly patients with dementia, and then hid those kickbacks as payments for services that Omnicare never actually provided. Omnicare then enacted intervention programs such as the “Risperdal Initiative” to persuade physicians to prescribe the drug to elderly dementia patients.

Omnicare, the largest pharmaceutical supplier for nursing homes in the U.S., has pharmacists on staff who review patients’ records and then makes recommendations to the patients’ physicians. Those recommendations are followed about 80% of the time, the DOJ said.

The claims were originally made by Omnicare pharmacist Bernard Lisitza in 2003, and the DOJ chose to intervene on Lisitza’s behalf.

Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

Risperdal (risperidone) is manufactured by Janssen, a division of Ortho-McNeil-Janssen, which is a subsidiary of Johnson & Johnson. Risperdal is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism, but it is commonly used among elderly with dementia and sometimes as a form of chemical restraint in nursing homes.

Risperdal is not approved for treatment of dementia, and patient advocates have been pushing nursing homes to reduce the use of the drug among elderly due to the health risk and a lack of actual health benefits. According to a recent report from the United Kingdom, side effects of Risperdal and other similar antipsychotics, like Seroquel, Zyprexa and Abilify, could be linked to as many as 1,800 deaths and 1,620 strokes per year in elderly patients with dementia.

http://www.aboutlawsuits.com/risperdal-omnicare-lawsuit-proceeds-16571/

To see more international drug regulatory warnings and studies on Risperdal and other antipsychotic drugs, visit CCHR’s Psychiatric Drug Side Effects Database here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

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Lawsuit Alleges Johnson & Johnson Pushed Drugs on Seniors

cchrint — Thu, 08 Apr 2010 19:41:15 +0000

ConsumerAffairs.com
By Jon Hood
April 8, 2010

A lawsuit filed last week accuses Johnson & Johnson of conspiring with pharmaceutical consultant Omnicare in an effort to push J&J drugs on nursing home residents, and violating federal Medicaid laws in the process.

As a result of the scheme, “residents were overcharged for their medications, had additional medications administered and were unlawfully switched to Johnson & Johnson drugs,” all in the name of increasing revenue, according to the lawsuit.

The suit, filed in federal court in California, says Omnicare — which “occupies a ‘dual’ role of a dispensing pharmacy and consulting pharmacy” — gave certain J&J drugs “elevated status as the default drug of choice” for thousands of nursing home patients. J&J allegedly gave Omnicare “performance rebates” — essentially kickbacks — in return for its services. This arrangement was memorialized in a 1997 “Supply Agreement” between the two companies, the suit states.

The agreement provided that the two companies would “meet quarterly to review their joint ‘business plan’ and ‘performance goals,’” and came up with a novel way to deal with the performance-rebates: they would be treated as year-end bonuses.

The drugs allegedly targeted for promotion under the agreement included Floxin, Levaquin, Risperdal, Ultram, Duragesic, Procrit, and Aciphex.

The suit contends that under the agreement, J&J paid to have its drugs labeled as “preferred” — a status that Omnicare purportedly confers on drugs that receive high marks “for their clinical effectiveness in the geriatric community.”

Read entire article: http://www.consumeraffairs.com/news04/2010/04/jnj_omnicare_suit.html

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$112 million settlement: charged with kickbacks from drug company & recommending docs prescribe antipsychotic drug Risperdal

cchrint — Wed, 04 Nov 2009 18:02:03 +0000

Reuters
November 3, 2009

Omnicare Inc, the largest U.S. provider of pharmacy services to nursing homes, will pay $98 million and Teva subsidiary IVAX Pharmaceuticals will pay $14 million to settle allegations of kickbacks, the U.S. Department of Justice said on Tuesday.

The department said Omnicare both solicited and paid kickbacks.

Omnicare allegedly asked IVAX to pay $8 million in exchange for agreeing to purchase $50 million in IVAX drugs, the DOJ said.

It also accused Omnicare of soliciting kickbacks from Johnson & Johnson in exchange for recommending that physicians prescribe the antipsychotic drug Risperdal to nursing home patients.

“J&J’s kickbacks to Omnicare took multiple forms, including rebates that were conditioned on Omnicare engaging in an ‘Active Intervention Program’ for Risperdal and payments disguised as data purchase fees, educational grants, and fees to attend Omnicare meetings,” the Justice Department said.

Read entire article: http://www.reuters.com/article/healthcareSector/idUSN0350746820091103

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CCHR International » Omnicare

Cause for alarm: Antipsychotic drugs for nursing home patients

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