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Overuse of antipsychotic meds risks lives of the elderly


Orange County Register (CA)

06-18-13

June 16--Grandma didn't smile anymore.

After four months at Carriage House Nursing Center and Windsor Gardens of Fullerton, 94-year-old Joanna Sienkiewicz had gone from spry and bossy to barely there. Medical records indicate attendants were giving her 15 milligrams a day of the powerful antipsychotic drug, Abilify, noting she was agitated and resisted care.

"Before she was lively, then she became completely listless," said granddaughter Anna Woronowicz, 34. "It was awful. We felt powerless."

At Windsor Gardens Convalescent Center of Anaheim, Richard Millikan, 71, was sedated on antipsychotics although his family never gave their consent, his ex-wife, Maria, alleged in a lawsuit.

"They kept him thoroughly sedated all the time, they never moved him, they never gave him any attention," Maria Millikan said.

At Windsor Vallejo Care Center, Robert Sohl, 87, was so doped out on the antipsychotic Seroquel, his family said in a lawsuit, that he stopped eating and drinking, eventually dying from dehydration.

"He was completely in la-la land. He didn't know who he was or where he was," said his daughter, Michelle Sohl.

The federal Food and Drug Administration warns that antipsychotics should not be used on elderly people with dementia. Prescribing such drugs to the elderly for dementia or Alzheimer's can hasten death, according to the FDA. Yet, medical experts and federal regulators say antipsychotic drugs are being used at an alarming rate by nursing homes to chemically restrain hard-to-handle seniors. More than 20 percent of the residents in nursing homes across the country receive antipsychotic drugs for reasons not approved by regulators, according to data analyzed by the Orange County Register.

The federal Centers for Medicare and Medicaid Services (known as CMS) began tracking the use of antipsychotics in nursing homes for quality purposes in 2011, after an Office of Inspector General report showed widespread abuse in convalescent centers. Despite a campaign by regulators to reduce such dosing, experts say progress is slow.

"Most of the care in nursing homes is pharmacological," said Dr. Victor Molinari, professor of aging at the University of South Florida. "Some people say nursing homes are basically psychiatric institutions without the trained psychiatric staff. There's this tendency to overuse psychiatric medicine and underuse other methods."

Molinari continued, "The issue is not heartless nursing home administrators, it's just they feel they don't have the resources to combat the problem. They reach for the prescription pad as opposed to having a more thoughtful approach to what's triggering the erratic behavior."

While nursing home reform advocates say antipsychotics are often used to offset low staffing, an analysis by the Register of 12,000 homes nationally failed to find a statistical association between low staffing and abusive drug prescriptions, meaning that low staffing is not a reliable predictor of over-use of antipsychotic drugs.

Federal agencies have fined pharmaceutical companies, including Astra Zeneca, Eli Lilly and AbbVie, for illegally marketing antipsychotics such as Seroquel, Zyprexa and Depakote, for "off-label" uses. Doctors are often paid to help with such marketing. Newly mandated federal disclosures show that drug companies have paid millions of dollars to thousands of doctors for helping to test or promote many of their drugs.

TRYING 'WARM MILK'

Joanna Sienkiewicz, Richard Millikan and Robert Sohl, the elderly patients whose deaths prompted lawsuits, were all in nursing facilities operated by Los Angeles-based S&F Management, which used the brand name "Windsor."

An analysis by the Orange County Register of 2011-12 data provided by the CMS found that Windsor residents received dangerous antipsychotic drugs at a rate higher than any of the largest chains in California, defined as those with more than 3,000 beds. Twenty-six percent of Windsor residents without schizophrenia received antipsychotics, compared to a statewide median of 17 percent. Nationally, the median is 22 percent.

Officials at the 3,865-bed Windsor chain insisted that they discourage the use of antipsychotics to control difficult patients who are not schizophrenic.

"It's frowned upon and discouraged. Can I say it doesn't happen 100 percent of the time? I probably can't say that," said Dr. Jameel Hourani, Windsor's corporate medical director. "We prefer to use non-pharmacological methods to treat patients, initially. If we can't stop (the behavior), we'll try to give them warm milk."

Hourani suggested that the Windsor chain's numbers are skewed by one home that specializes in patients with psychological problems, Windsor Palms Care Center of Artesia. CMS data shows that 60 percent of patients there are on antipsychotics, one of the highest rates for antipsychotic use in the nation.

"No other nursing homes will take these (mental health) patients," Hourani said.

Disclosures by drug companies show that Hourani and a drug research company he worked for were paid nearly $1 million to conduct research on behalf of companies that produce antipsychotics and other drugs in 2011 and 2012. Hourani said that his former employer, California Clinical Trials, received the bulk of the $977,257 that drug companies paid for that research.

Hourani, who graduated from the West Virginia School of Osteopathic Medicine, was the principal investigator on research funded by Pfizer, maker of the antipsychotic drug Zeldox, and Merck, maker of Saphris, according to those companies' disclosures. Hourani was also paid $38,513 directly in 2012 by Forest Pharmaceuticals, maker of the antipsychotic Cariprazine, for speaking, meals and travel.

Although Hourani is the head physician for the Windsor homes, he said he only prescribes drugs for the Windsor home in Los Angeles and that it is Windsor psychiatrists who prescribe the antipsychotics. CMS data shows that home, Windsor Care Cheviot Hills, prescribes antipsychotics to 16 percent of its patients, below the state median.

Sienkiewicz entered Carriage House in September 2005, which became Windsor Gardens during her four-month stay.

Records show that Sienkiewicz, who suffered from dementia, was given an antipsychotic drug called Abilify for "psychosis manifested by agitation and resisting care." Her family alleged in a lawsuit that Carriage House Nursing Center and Windsor Gardens of Fullerton did not get the required consent to give the drug. The family believes the drug was used mainly to restrain her from acting out.

"She was out of it. Not coherent. Not interacting with us," said Anna Woronowicz, the granddaughter. "She didn't seem happy to be with us."

Abilify and other antipsychotics are not federally approved for the treatment of Alzheimer's or dementia. In fact, the Food and Drug Administration offers its strongest warning, known as a "black box warning," that such use can increase the likelihood of death. There's an increased risk of stroke, heart attack and falls. But there are no laws prohibiting doctors from prescribing the medication for an "off-label" use -- that is, for medical conditions for which a drug has not been approved.

Costa Mesa psychiatrist Jason Kellogg, who specializes in geriatrics, approved the Abilify for Sienkiewicz, according to medical records. Kellogg in 2010 prescribed antipsychotics to 66 percent of his patients in a Medicare subsidy program called Part D, compared to the national average of 49 percent, according to a database compiled by the ProPublica online newsroom.

Kellogg did not respond to requests for an interview, which were left with a secretary.

Sienkiewicz died in January of 2006 after being moved to a hospital because her blood had become infected, according to her family.

Sienkiewicz's daughter, Marie Woronowicz, sued Windsor and Kellog for wrongful death, lack of informed consent and medical malpractice. The case was settled out of court, according to legal records, and the settlement remains confidential.

Richard Millikan's ex-wife said in a 2008 lawsuit that informed consent was not obtained from his family before he was given antipsychotic drugs at Windsor Gardens Convalescent Center of Anaheim. Millikan suffered from dementia and died in June 2008 from pulmonary congestion. His death certificate also says he suffered from leg ulcers. Maria Millikan said she was forced to drop her suit because she didn't have any legal standing as a former spouse.

Federal numbers show that Windsor Gardens of Anaheim administers antipsychotics to 43 percent of its patients who do not have a diagnosis of schizophrenia. That's nearly triple the state rate.

Carole Lillis, vice president of clinical services for Windsor, said she could not comment on individual cases. But Lillis said the CMS data doesn't account for some psychosis-causing ailments, such as manic depression. Lillis added the company has been striving to meet a 15 percent reduction in the use of antipsychotics, a goal set nationally by the CMS.

About 17 percent of the residents at Windsor Gardens in Fullerton, where Sienkiewicz stayed, typically receive antipsychotic drugs without a diagnosis of schizophrenia, according to the 2011-2012 data.

That rate is equivalent to the median for all California nursing homes.

FEDERAL REGULATORS 'SENDING A MESSAGE'

The California Advocates for Nursing Home Reform warn against leaving loved ones at homes with a high rate of antipsychotic drug use.

"Unless you have a severe mental illness and have a legitimate need for these drugs, it is not safe to enter a nursing home that uses antipsychotic drugs at a high rate," says the group's website.

Data collected by the federal CMS shows that an average of 22 percent of the people in nursing homes nationally were receiving antipsychotics in December 2012, down from 23 percent in June 2011. That's far below the 15 percent reduction sought by CMS but trending in the right direction, according to CMS officials.

Besides Windsor, the 3,765-bed Longwood Management chain -- which operates Park Anaheim Health Care -- is at 21 percent, well above the state median. The other large California chains -- Plum, Country Villa, The Ensign Group, Skilled Healthcare, Sava Senior Care and Covenant -- are at or below the state's 17 percent median.

Hoping to curb the use of antipsychotics in nursing homes, CMS officials search for such things as excessive dosing or prolonged use, issuing fines that can reach into the thousands per day.

"We are sending a loud and clear message from CMS that there will be enforcement for any misuse," said Alice Bonner, who oversaw nursing homes for the CMS until she was promoted to another position this year.

Surveyors in each state -- who annually visit each nursing home -- are being trained by the CMS to watch for antipsychotics abuse.

A 2011 investigation by the Office of Inspector General for the Department of Health and Human Services found that 83 percent of antipsychotic drug claims in nursing homes were for uses not approved by the FDA. Moreover, $116 million in claims did not fit Medicare reimbursement criteria.

Omnicare, Inc., a large pharmacy which serves Windsor and other chains, agreed in 2009 to pay $98 million to settle federal allegations that it received kickbacks from pharmaceutical manufacturers for recommending their antipsychotic drugs for use in nursing homes, according to the OIG investigation.

The company issued a prepared statement when asked for comment: "Omnicare, like other companies in the industry, continues to work closely with CMS and prescribing physicians to reduce the use of antipsychotic drugs in nursing homes."

Pharmaceutical companies have also paid heavy fines for suggesting to doctors that they prescribe antipsychotics for unapproved uses.

In 2007, Bristol-Myers Squibb paid $515 million to settle federal investigations for, among other things, promoting Abilify for uses not approved by the FDA.

In 2010, AstraZeneca agreed to pay $520 million to settle federal and state civil accusations it promoted "off label" use of the drug Seroquel to doctors who treat the elderly and children.

In a statement sent to the Register, AstraZeneca said it tries to comply with all federal laws and regulations.

"It is and was AstraZeneca's policy to promote our medicines and to conduct interactions with healthcare professionals in compliance with the laws and regulations that govern the healthcare community in the United States. We train AstraZeneca employees to follow our compliance policies," wrote company spokesman Tony Jewell in an email.

Many in the nursing home industry agree that antipsychotics are being over-used.

"It's the view of our association that the number of residents being prescribed antipsychotics can be reduced and we continue to explore ways to help our members prevent and manage difficult behavior without medications," said Deborah Pacyna, spokeswoman for the California Association of Health Facilities, which represents about 60 percent of the nursing homes in the state.

Nursing home reformers say the answer is more therapy and fewer chemicals.

"They shouldn't have to rely on the crutch of psychotropic drugs. The answer isn't a pill," said Anthony Chicotel, attorney for association. "It makes you less active and less able to communicate your needs."

In California, only six out of 927 nursing homes do not appear to use antipsychotic drugs, including the Sun Mar Nursing Center in Anaheim.

"We try and avoid the antipsychotic drugs. The spiritual aspect (of treatment) is very important and we have wonderful family support," said Sarah Lee, social services director for Sun Mar.

Lee noted all the residents are Korean speakers, as well as all the caregivers.

"We just provide quality of care," said Lee. "Most of the time, it works."

___

(c)2013 The Orange County Register (Santa Ana, Calif.)

Visit The Orange County Register (Santa Ana, Calif.) at www.ocregister.com

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Copyright Orange County Register (CA) 2013

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