Posts Tagged ‘Alzheimer’s’

Is J&J Cooking Its Books? Suit Alleges Double-Counting at the Pharma Giant

Wednesday, March 2nd, 2011

BNET – March 1, 2011

by Jim Edwards

A whistleblower lawsuit filed against Johnson & Johnson (JNJ) didn’t get much attention in the media because the unproven accusations within it — paying kickbacks to nursing home pharmacy Omnicare (OCR) — sounded familiar. But the details in the complaint are worth exploring because they go further than the usual allegations of paying for no-work contracts to boost pharmacy distribution of their drugs.

Plaintiff Scott Bartz, a former sales compensation manager at J&J, alleges that the company is cooking its books in two ways, both of which could lead to prison time for senior managers if his allegations are true:

  • The company is overstating its revenues by counting the discounts it pays to drug repackagers under the “cost of goods sold” line on its income statement. COGS are supposed to reflect manufacturing and shipping costs, not price discounts and rebates.
  • The company is double-counting sales of the injectable antipsychotic Risperdal Consta as the drug passes through wholesalers and retailers. The double-counting is part of a “channel-stuffing” scheme in which the company falsely inflates its sales by counting shipments to wholesalers as if they were actual sales at the retail level.

J&J has yet to respond to the suit, which was unsealed in December and didn’t surface in regulatory filings until last week. The company will be comforted by the fact that the Department of Justice has so far declined to intervene. That doesn’t necessarily mean the DOJ believes the case is without merit; the DOJ chooses its cases based on a range of criteria, including policy priorities and available resources. Nonetheless, the accusations should be taken with a pinch of salt until J&J responds.

The last time channel stuffing reared its ugly head in the drug industry was when Bristol-Myers Squibb (BMS) settled fraudulent accounting charges with the SEC for $150 million. In that case, BMS’ former president and CFO were indicted for fraud and conspiracy, but the charges were dropped last year in favor of a pair of deferred-prosecution agreements and $400,000 in fines.

Bartz worked for J&J from 1999 to 2007 and had responsibility for analyzing J&J’s financial and sales data from companies such as IMS Health, a market research company whose information is used as an industry benchmark. In 2004 and 2005, Bartz noted an alleged discrepancy between the amount of Risperdal Consta J&J sold to three wholesalers and the amount that pharmacies actually sold to patients:

  • J&J’s Risperdal Consta sales to wholesalers McKesson, Cardinal and AmeriSource Bergen
  • 2004: $130 million reported; $75 million actually sold
  • 2005: $285 million reported; $145 million actually sold

Bartz investigated, and found further alleged discrepancies. Alkermes, the company that makes Risperdal for J&J, reported worldwide sales to J&J’s Janssen unit worth $1 billion in 2005, Bartz alleges. But Janssen’s net sales of that drug in the same year were only recorded as $664 million; and sales from outlets and other distributors were $390 million, Bartz claims. J&J concealed its channel-stuffing scheme by counting the same sales twice, Bartz claims (click to enlarge):

The discrepancy between the sales J&J racked up with its wholesalers and actual sales at retail and pharmacy level did not go unnoticed, Bartz claims. An IMS Health executive said that there seemed to be “very little sellout” of some Risperdal Consta shipments that J&J had sent to McKesson:

Bartz alleges channel stuffing was widespread at J&J:

Plaintiff has also discovered that the practice of channel stuffing was used in all or most of the J&J products as a means to increase profit margins of distributors such as McKesson, Cardinal and AmeriSource Bergen.

For investors, the most serious allegation Bartz has to make is furnished with the least detail. He claims that J&J inflated sales of the Alzheimer’s drug Razadyne through a number of different schemes, including removing sales from the company’s books only to reinsert them once the books were closed at year’s end, and pretending that discounts J&J offers to repackagers on the drug are manufacturing costs:

That scheme would allow J&J to pretend it is making more money on the drug than it actually is, albeit at smaller margins. Oddly, the net effect of such a scheme on J&J’s bottom line would be a wash, but it would give outside observers the impression that the market for Razadyne is bigger than it actually is.

Bartz claims he was harassed and demoted after he complained to management that he believed the company’s accounting was false. He claims he had a stress-induced heart attack before he was finally terminated in 2007.

http://www.bnet.com/blog/drug-business/is-j-j-cooking-its-books-suit-alleges-double-counting-at-the-pharma-giant/7552

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Senate Aging Panel Blows Whistle on Over Drugging Dementia Patients

Tuesday, March 1st, 2011

“Beautiful young people are accidents of nature, but beautiful old people are works of art.” — Eleanor Roosevelt

Natural News,  March 1, 2011

by Monica G. Young

Pharmaceutical companies view the elderly as a lucrative market. However a panel of experts at the recent Senate Aging Committee forum decided to speak up. Over-medication occurs far too often in those diagnosed with dementia, the panel warned, and as baby boomers age the problem will only worsen.

One reason overmedication occurs, per this panel, is family members, caregivers, and nursing home workers often misinterpret patients’ complaints about physical ailments as unruly or aggressive conduct. To manage their behavior, such patients are administered antipsychotics they don’t need.

About five million patients are currently diagnosed with Alzheimer’s and other forms of dementia. “Those in this field have a feeling we’re headed in a very fast train toward the end of a cliff,” stated Patricia Grady, PhD, director of the National Institute of Nursing Research.

Director of California Advocates for Nursing Home Reform, Patricia McGinnis, demanded nursing homes be held “accountable” for the drugs they administer. “The way anti-psychotic drugs are used in nursing homes is a form of elder abuse,” she told the forum. “Instead of providing individualized care, many homes indiscriminately use these drugs to sedate and subdue residents.”

McGinnis urged for more informed consent before antipsychotics are given. She cited her own 89-year-old mother who was hospitalized for a broken hip, discharged to a nursing home and given an antipsychotic. McGinnis said her mother did not have dementia and didn’t need the drug, and family members were never consulted.

Professor of Nursing at the University of Wisconsin, Christine Kovach, spoke of an elderly patient who kept saying “No, no, no” and protesting whenever someone tried to move her. She was put on an anti-psychotic. X-rays later disclosed an untreated broken hip.

Nonpharmacological approaches can help, said Laura Gitlin, PhD, Director of the Jefferson Center for Applied Research on Aging and Health in Philadelphia. She listed alternatives like personal counseling, education, skill training of family members, and simple and engaging activities.

Antipsychotics have been widely used to squelch disruptive behavior among people with dementia. However these drugs are especially life-threatening to older people, raising the risk of strokes, diabetes and falls.

“There’s a bunch of problems, not least of which is those drugs can kill you,” reported Dr. Mark Kunik at Baylor College of Medicine in Houston at the annual Gerontological Society of America’s meeting. Instead of looking for physical causes of disruptive behavior, doctors typically prescribe drugs for dementia patients, he said, because “It’s the easy thing to do. … That’s true in hospitals, in clinics and in nursing homes.”

“Whether you have Alzheimer’s or not, there’s a reason people get frustrated or upset — pain, urinary tract infections, hunger, fear of strangers or loud noises or strange settings, maybe drug interactions,” Kunik stated. “If you figure that out, you likely can find a safer, nonpharmacologic treatment.”

There are alternatives that work. Eva Lanigant, a resident care coordinator for a facility in Minnesota, was tired of seeing elderly patients drugged into a stupor. Working with a psychiatrist and a pharmacist, she started a project to replace drugs with massage, games, exercise, personal attention, better pain control and other techniques. They trained the entire staff to interact with dementia residents.

Within six months they eliminated antipsychotic drugs and cut antidepressant use by half. Lanigan reported, “The chaos level is down, but the noise is up: the noise of people laughing, talking, much more engaged with life.  It’s amazing.”

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Now this, is the kind of mental therapy we can get behind—”Psychiatrist tries a different approach with dementia patients”

Tuesday, January 4th, 2011

STAFF PHOTO / CRAIG LITTEN - Dr. Miguel Rivera visits with patient Helen Kidd last month at the Pines of Sarasota. Under Rivera's direction, Pines caregivers have deployed some simple spa comforts to reduce agitation. As a result, dosages of antipsychotic drugs have dropped.

Herald Tribune
By Barbara Peters Smith
January 2, 2011

The pixie-like patient in a pink dress and a long, flirty strand of pearls lights up as visitors approach, and scoots her wheelchair along the corridor to give them her standard greeting.

“Okinawa! Saipan! Iwo Jima! Rome!” she chirps, alluding to the military career that took her around the world — long before dementia brought her here, to the Garden Memory Unit at Pines of Sarasota.

She tags along as the visitors inspect a shower room that has been freshly painted with an expansive scene of Gulf-front sand and sky. Isn’t that the most beautiful thing you’ve ever seen?” she asks them. “I love it in there!”

One of the Pines’ calming shower rooms.

Dementia patients can get anxious to the point of violence while bathing, and this cheery beach mural is one of many small innovations that have lifted moods here in recent months. Under the direction of psychiatrist Dr. Miguel Rivera, caregivers at the Pines have deployed such simple spa comforts as music, massage and calming colors to help reduce agitation. As a result, dosages of antipsychotic medications have dropped to less than half the state average for this most challenging patient population.

Rivera, a gentle, sweet-spoken native of Puerto Rico who completed his psychiatric residency at the University of South Florida in 2001, stresses that none of these therapeutic tactics are his own invention.

“These were not things they taught us in our residency program, but I didn’t create them, either,” he says. “I’m more the person that maybe has the credentials to bring this to people, and people will tend to believe me because I have this M.D. behind my name.”

But Pam Polowski, the Alzheimer’s Association program specialist for Sarasota County, says Rivera works a kind of magic that is rare in this field.

“One of the things that is really important to know is that we can’t drag our dementia patients into our world,” Polowski says. “We have to go to their world and join them on that journey. And he gets that.”

Dementia is a loss of brain function that cripples memory, emotions and behavior. Medicare payments for services to dementia patients are expected to total $172 billion in 2010. So low-cost interventions such as Rivera’s could save tax dollars.

In a light-filled common room at the Pines, activities director Shirley Riesz is using karaoke to help 20 or so residents power through the normally trying hours before suppertime. Dementia patients’ circadian rhythms can make them prone to “sundowning,” Rivera explains, when they “begin to pace, get aggressive, want to go home and set off alarms” on the unit’s doors to the outside world.

A music therapy session at any long-term care facility can be a dreary, halfhearted ritual. But here, the atmosphere is alive. As “High Hopes” plays, Riesz holds the microphone for a man who sings out strongly, “Whoops, there goes another rubber tree plant!”

Even those not joining in are attentive and mostly smiling. Several wave at Rivera, and he waves delightedly back.

“They don’t know I’m a doctor,” he said, indicating his casual, golf-style shirt. “They just think I’m this friendly guy who comes around a lot.”

Through research and trial and error, Rivera has discovered that what he calls “courting music” — from the days when his patients were young and in love — evokes the most dramatic responses. He explains that the vivid connection between a particular song and a potent emotion reflects “things that the mind doesn’t really know. If you are really able to concentrate and visualize through music, you get transported and the body responds.”

Rivera tells the story of Ann, who moved to the memory unit from the assisted-living section of the Pines after a stroke. Unable to speak, she was despondent and withdrawn.

“I had the intuition that what we really needed to do was to start her on a singing program,” he recalls. “We started to notice early on that she was able to sing words and phrases that she was not able to speak. Little by little, it started to spill into her day. She started saying ‘OK’ or ‘yes’ or ‘no.’ We never knew that she liked coffee until the other day, when she told Shirley, ‘I love coffee.’ So now she gets to enjoy her coffee.”

And there is Grace, the patient so upset by the bathing process that she was giving her attendant bruises.

“This is a Monday ritual without fail,” Riesz wrote in a recent e-mail message to Pines education director Joann Westbrook. “But today there was NO screaming, just laughing, dancing and singing.”

The song that did the trick, according to certified nurse assistant Valrie Miller, was “Will You Love Me Tomorrow?” After the first nonviolent bath time, Miller says, Grace asked her, “Will you love me today?”

Thanks to a small grant that paid for iPods and “courting music”; waterproof plastic iPod holders made by Rivera’s neighbor, a retired engineer; and those calming beach scenes painted by Westbrook’s husband, K.C. Higgins, the Pines found a way to do for Grace what the strongest pharmaceuticals could not.

“What is ironic,” Riesz added, was that “her daughter gave me a preferred music CD and it has no connection or relation to the genre she was enjoying. Let that be a lesson to us: Make up your preferred playlist of music now, because someday your children may do it for you.”

Rivera, who works as a mental health medical director for seven long-term care facilities in Sarasota, did not plan any of this.

He came to Sarasota in 2001 with what he now calls the “grandiose” idea of running an alternative, yoga-based medical practice that would “teach people how to change their lives.” The business failed.

“Right around the same time that this is disappearing,” he says, “I get a call from Bruce Robinson, the chief of geriatrics at Sarasota Memorial. And he said, ‘Hey, I heard you were in Sarasota; would you mind doing some nursing home consultations for me?’ They say in Spanish, when you’re born to be a hammer, it rains nails from the skies.”

Robinson says finding trained psychiatrists to take on this work is a struggle.

“There’s a desperate need for more mental health care in long-term facilities,” he says. “It’s a shame there aren’t more doctors like Miguel. He’s there. He answers his phone.”

Rivera took to his mission right away. But he was frustrated that his only option for helping distraught patients was to increase their medications.

“I remember so many times walking through that old west hallway at the Pines” before the building was remodeled, he says. “After the first few years of me working there and seeing how people were overmedicated, and boredom was so prevailing, I remember — and I feel it right now — just walking down that hall, and praying, saying, ‘Please, God, show me a way.’ ”

It was Rivera’s wife, Natasha, he says, who put him on a path to exploring alternatives to drugs. Both practitioners of TriYoga, they met in 2007 on a spiritual trip to India. By the end of the three-week stay, they were married. A year later, she joined him in Sarasota from her native Russia. And almost immediately, Rivera says, she changed the way he was doing his job.

“All of a sudden there is this fresh pair of eyes that is asking all these questions,” he says. “‘What is Alzheimer’s disease? Why do people get it?’ It made me look at things; it took me out of that automatic mode.”

Rivera soon found research on the use of music, massage and other therapies on dementia patients. His reading also led to the use of daily affirmations by Pines staffers, who tell the patients, “You are safe; you are loved; you are happy.” The result, says Westbrook of the Pines, was “this whole beautiful circle he has created here that has changed that unit.”

Robinson views Rivera’s work from a more scientific standpoint, and applauds the fact that out of some 40 patients in the Pines memory unit, only eight are taking antipsychotic drugs.

“I am happy to have them report that,” he says. “Since the only evidence we have for the effects of antipsychotics is that they kill people, anything that can reduce that is a good thing.

“The life of an old person with dementia can be very meager: Where’s the fun?” Robinson adds. “The idea of having something positive in your life, like massage — all those things have an evident face validity.”

Read the rest of the article here:  http://www.heraldtribune.com/article/20110102/ARTICLE/101021037/2055/NEWS?p=1&tc=pg

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Nursing homes are seeking to end the psychiatric drug stupor

Sunday, December 5th, 2010

Note from CCHR: The wholesale psychiatric drugging of the elderly in both private and public nursing homes has reached epidemic levels, with the use of antipsychotics, antianxiety drugs (tranquilizers) and antidepressants  skyrocketing and patients being harmed and killed as a direct result.  These drugs are highly dangerous when prescribed to anyone, but when prescribed to the elderly the risks for diabetes, stroke and sudden death are greatly increased.    As stated in the article below, ” Instead of looking for causes of disruptive behavior among dementia patients, doctors typically prescribe drugs to mask the symptoms… because it’s the easy thing to do. … That’s true in hospitals, in clinics and in nursing homes.” It is for this reason we feel the more humane non-drug approach being undertaken by this particular chain of nursing homes in treating elderly patients  suffering from dementia should not only be commended, but employed by all nursing homes caring for the elderly.

The Star Tribune – Dec 4, 2010

by Warren Wolfe

Instead of treating behavioral problems with antipsychotic drugs, the Ecumen chain of 15 homes is using strategies including aromatherapy, massage, music, games, exercise and good talk. The state is helping out.

The aged woman had stopped biting aides and hitting other residents. That was the good news.

But in the North Shore nursing home’s efforts to achieve peace, she and many other residents were drugged into a stupor — sleepy, lethargic, with little interest in food, activities and other people.

“You see that in just about any nursing home,” said Eva Lanigan, a nurse and resident care coordinator at Sunrise Home in Two Harbors, Minn. “But what kind of quality of life is that?”

Working with a psychiatrist and a pharmacist, Lanigan started a project last year to find other ways to ease the yelling, moaning, crying, spitting, biting and other disruptive behavior that sometimes accompany dementia.

They wanted to replace drugs with aromatherapy, massage, games, exercise, personal attention, better pain control and other techniques. The entire staff was trained and encouraged to interact with residents with dementia.

Within six months, they eliminated antipsychotic drugs and cut the use of antidepressants by half. The result, Lanigan said: “The chaos level is down, but the noise is up — the noise of people laughing, talking, much more engaged with life. It’s amazing.”

Now the home’s operator, Shoreview-based Ecumen, has started a project called Awakenings throughout its 15 long-term care nursing homes. It’s based on Lanigan’s work and funded with a two-year, $3.7 million state grant.

“We saw what Eva was doing — something everybody in the industry talks about — and we were impressed,” said Mick Finn, an Ecumen vice president. “We said, ‘Hey, this is real. Can we all do this?’ ”

The dangers of drugs

Powerful antipsychotic drugs have been used for years to reduce agitation, hallucinations and other debilitating symptoms among people with mental illnesses.

They also are widely used “off label” to quell disruptive behavior among people with Alzheimer’s disease and other forms of dementia.

Medicare spends more than $5 billion a year on those drugs for its beneficiaries, including about 30 percent of nursing home residents. Several studies have concluded that more than half are prescribed inappropriately. The drugs are especially hazardous to older people, raising the risk of strokes, pneumonia, confusion, falls, diabetes and hospitalization.

“There’s a bunch of problems, not least of which is those drugs can kill you,” said Dr. Mark Kunik at Baylor College of Medicine in Houston who spoke last month at the Gerontological Society of America’s annual meeting in New Orleans.

Instead of looking for causes of disruptive behavior among dementia patients, doctors typically prescribe drugs to mask the symptoms, he said, because “It’s the easy thing to do. … That’s true in hospitals, in clinics and in nursing homes.”

Federal regulators are cracking down on homes that don’t routinely reassess residents on psychotropic drugs. But use remains widespread.

“Whether you have Alzheimer’s or not, there’s a reason people get frustrated or upset — pain, urinary tract infections, hunger, fear of strangers or loud noises or strange settings, maybe drug interactions,” Kunik said. “If you figure that out, you likely can find a safer, nonpharmacologic treatment.”

Treating loss with love

About 150 miles south of Two Harbors, Bernice Brockelman, 91, was snacking on cookies last Wednesday beside the Christmas tree at Ecumen Parmly LifePointes, a nursing home in Center City — all the while alternating quickly from calm to worry to calm.

“Can I stay here tonight? I don’t know where to go. Can I stay with you?” she asked Christy Johnson, the home’s therapeutic recreation director. Though Johnson reassured her, she asked the question again — and again and again.

In an effort to calm her while preparing to wean her from pills, the Parmly staff invited Brockelman into a game of Bingo and to recite the Polish phrases she learned from her immigrant parents. Then she spotted a male visitor.

“Hey, is he married?” she asked with a sparkle in her eye.

“When she’s feeling good, Mom’s an outrageous flirt and she can be really funny,” said her daughter, Judy Balthazor of Center City. “But often there is the repetitive questions, the worry, sometimes just being washed out. I can’t wait for them to get her off her drugs.”

Until the Awakenings project, few at the home knew Brockelman’s whole story — the loss of both parents when she was in high school, of her husband at age 46, then two sons, a close friend and a nephew. Found to have psychosis and dementia, she “just shut down because she had so many losses,” Balthazor said.

Now, the Parmly staff is gaining deeper knowledge of 15 residents who are on psychotropic drugs and who frequently are agitated or upset. They are about to start weaning the residents from the drugs, but they’ve already started a range of activities tailored to each.

Some say nursing homes cannot afford to replace drugs with personal attention because it requires too much staff time.

“Our guess is that it will take the equivalent of two extra people at each home, spread across all job categories,” said Finn, Ecuman’s vice president. “Can we afford it? We think we have to, because it’s the right thing.”

Brockelman, who lived nearly all of her life in northeast Minneapolis, loved to bake, so now she helps make bread and cookies. She danced and was physically active, so she walks with an aide and taps her toes to polka music. A devout Catholic, she attends several weekly church services. She plays Bingo with aide Jenna Miller and sometimes other residents.

“When [you] understand who Beatrice has been in the past, you know her a lot better in the present,” Miller said. “With the Awakenings project, I have permission to spend the time I need with Bernice so she feels safe and loved.”

http://www.startribune.com/lifestyle/health/111326224.html?page=1&c=y

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Scandalous abuse of the elderly prescribed antipsychotics in hospital exposed

Wednesday, October 7th, 2009

Rebecca Smith
The Daily Telegraph
October 7, 2009

Three quarters of nurses have seen people with dementia in general wards in hospital prescribed antipsychotic drugs that are known to double the risk of death and triple the risk of a stroke in these patients, research has shown.

It is the first time the scale of the abuse in hospital wards is exposed, following warnings that 100,000 dementia patients in care homes are prescribed the drugs leading to the deaths of 23,000 a year.

Ten leading charities, carers groups and experts have written to The Daily Telegraph saying: “We cannot stand by while this scandalous abuse of vulnerable citizens continues.”

Neil Hunt, Chief Executive of Alzheimer’s Society said: “The massive over prescription of antipsychotics to people with dementia is an abuse of human rights, causing serious side effects and increasing risk of death.

Read entire article: http://www.telegraph.co.uk/health/healthnews/6264962/Scandalous-abuse-of-the-elderly-prescribed-antipsychotics-in-hospital-exposed.html

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