Elderly patients over-prescribed antipsychotic drugs

New York Post
Friday, December 02, 2011

In the United States, elderly patients with dementia are too often prescribed antipsychotic drugs to calm their disruptive behavior, a costly and risky practice that should end, experts said Wednesday
Instead, more care should be taken to determine why dementia patients may be acting up and treat those underlying causes, lawmakers were told at a hearing of the Senate Committee on Aging.
"As the baby boomer generation ages, it is imperative to address the overuse and misuse of antipsychotic drugs among nursing home patients," said Daniel Levinson, Health and Human Services Inspector General.

Levinson said recent government audits have raised concerns about the use of antipsychotics by elderly people with dementia in nursing homes, raising their risk of death and wasting money for the US healthcare system.
For instance, more than half of such prescriptions were wrongly paid for in 2007 by government Medicare because the patients did not exhibit symptoms of schizophrenia or bipolar disorder, amounting to about 230 million dollars in waste.
One audit showed 14 percent of nursing home residents had Medicare claims for antipsychotic drugs, he said.
But another panel member, Toby Edelman, senior policy attorney in the office of the Center for Medicare Advocacy, said that audit's estimate was low because it only included some kinds of anti-psychotics.
"Nursing facilities' self-reported data indicate that in the third quarter of 2010, 26.2 percent of residents had received antipsychotic drugs in the previous seven days. That is approximately 350,000 individuals," she said.
"Facilities reported they gave antipsychotic drugs to many residents who did not have a psychosis, including 40 percent of patients at high risk because of behavior issues."
Edelman also pointed out that this issue is far from new, and that the same Senate committee had issued a report on the misuse of drugs in nursing homes back in 1975, and held a workshop on the topic two decades ago.
The practice persists, even though it is against federal law, because of serious understaffing in nursing facilities, high turnover of staff, and "aggressive off-label marketing of anti-psychotic drugs," she said.
The pharmaceutical giant Eli Lilly in 2009 paid a nearly 1.5 billion dollar settlement, in which it admitted no wrongdoing, for off-label promotion of its drug Zyprexa as a treatment for dementia. The drug is FDA-approved for bipolar disorder and schizophrenia.
According to Tom Hlavacek, executive director at Alzheimer's Association's southeastern Wisconsin chapter, elderly people with dementia are sometimes prescribed these potent drugs for behaviors that have other causes.
Urinary tract infections, tooth decay, arthritic pain, or simply moving a patient from one place to another can lead to agitated behaviors.
"Our experience indicates that these care transitions can exacerbate behaviors and often lead to escalating drug treatments," he told lawmakers.
Experts said solutions could include creating stronger penalties for inappropriate prescribing, and a renewed focus on trying non-pharmacological approaches to a problem first.
"Most doctors treat unwelcome behavior in all settings as a disease that requires medication. These drugs are used as chemical restraints," said Jonathan Evans, a doctor who specializes in caring for frail elders.
"Behavior is not a disease. Behavior is communication. And in people who have lost the ability to communicate with words, the only way to communicate is through behavior," he added.
"Good care demands we figure out what they are telling us and help them."

Confusing Medical Ailments with Mental Illness

WALL STREET JOURNAL online
August 9, 2011

An elderly woman's sudden depression turns out to be a side effect of her high blood-pressure medication.
A new mother's exhaustion and disinterest in her baby seem like postpartum depression—but actually signal a postpartum thyroid imbalance that medication can correct.
A middle-aged manager has angry outbursts at work and frequently feels "ready to explode." A brain scan reveals temporal-lobe seizures, a type of epilepsy that can be treated with surgery or medication.
More than 100 medical disorders can masquerade as psychological conditions, according to Harvard psychiatrist Barbara Schildkrout, who cited these examples among others in "Unmasking Psychological Symptoms," a book aimed at helping therapists broaden their diagnostic skills.

Different Diagnoses

More than 100 medical disorders can masquerade as psychological conditions or contribute to them, complicating treatment decisions.

WHAT SEEMS LIKE ...	MAY ACTUALLY BE ...
Depression	Underactive thyroid; low vitamin D or B-12 or folate; diabetes; hormonal changes; heart disease; Lyme disease; lupus; head trauma, sleep disorders; some cancers and cancer drugs
Anxiety	Overactive thyroid; respiratory problems; very low blood pressure; concussion; anaphylactic shock
Irritability	Brain injury; temporal lobe epilepsy;  disease and early stage dementia; parasitic infection; hormonal changes
Hallucinations	Epilepsy; brain tumor; fever; narcolepsy; substance abuse
Cognitive changes	Brain injury or infection; Alzheimer's; Parkinson's; liver failure; mercury or lead poisoning
Psychosis	Venereal disease; brain tumors and cysts; stroke; epilepsy; steroids; substance abuse

Source: WSJ reporting

Studies have suggested that medical conditions may cause mental-health issues in as many as 25% of psychiatric patients and contribute to them in more than 75%.
Untangling cause and effect can challenge even seasoned clinicians, and the potential for missed diagnoses is growing these days, said Dr. Schildkrout, who has more than 25 years of clinical practice in the Boston area. Most mental-health counselors rely on primary-care doctors to spot medical issues, but those physicians are increasingly time-pressed and may not know their patients well. Neither do the psychiatrists who mainly write prescriptions and see patients only briefly, she said in an interview.
Common culprits include under- or over-active thyroid glands, which can cause depression and anxiety, respectively. Deficiencies of vitamins D, B-12 and folate, as well as hormonal changes and sleep disorders have also been linked to depression.
Diabetes, lupus and Lyme disease can have a variety of psychiatric symptoms, as can mercury and lead poisoning and sexually transmitted diseases. Many medications also list mood changes among their side effects, and substance abuse is notorious for causing psychiatric problems.
Some underlying conditions are readily treatable. Others, such as Alzheimer's and Parkinson's disease and some brain tumors, are not. But a correct diagnosis can save months or years of frustration and ineffective treatment.
In some cases, a psychological problem is just the first sign of a serious medical issue. "Depression predicts heart disease and heart disease predicts depression," said Gary Kennedy, director of the geriatric psychiatry at Montefiore Medical Center in Bronx, N.Y.
About one-third of people who have their first episode of depression after age 55 have changes in brain circuits that are associated with hypertension, diabetes and heart attacks. Such patients are usually apathetic, have difficulty with executive planning and don't respond well to antidepressants. Making sure their blood pressure and blood-sugar levels are on target is crucial, though medical and psychotherapy may be needed as well, Dr. Kennedy said.
Recognizing an underlying medical condition can be particularly difficult when there is also a psychological explanation for a patient's dark moods. For example, victims of domestic violence are often anxious, depressed and withdrawn—but mild brain injury could be causing such symptoms, too.

Warning Signs

When to suspect a mental problem may be medical:
• Sudden change in mood or personality
• History of head trauma
• Depression that occurs for the first time after age 55
• Recent travel or exposure to infections
• Any rash, swelling, drooping eyelid; facial tic
• Standard medication or therapy isn't effective

Similarly, a former college athlete who becomes angry and irritable in his 40s could be suffering a midlife crisis—or delayed reaction to head injuries sustained decades earlier. "We now know that multiple concussions can have a sleeper effect for years. Then one day, out of the blue, you start acting explosive and depressed," due to a brain swelling known as chronic trauma encephalopathy, said Jerrold Pollak, a neuropsychologist at Seacoast Mental Health Center in Portsmouth, N.H., and lead author of an article on distinguishing mental from medical disorders in the Journal of Clinical Psychology Practice this spring.
If the head-injury diagnosis is missed, Dr. Pollak added, the patient could be in psychotherapy for months, "thinking that he has trouble with his father or feels like a failure for not becoming a pro athlete."
Giving every patient who seeks psychological help a brain scan first would be prohibitively expensive and likely yield many confusing results. But experts say mental-health counselors should ask patients about their medical histories as well as emotional issues, and make sure they've had a recent physical exam.
Tell-tale signs of underlying medical problems include significant changes in energy, weight, appetite or sleep, which could be due to an endocrine disorder. Sudden changes in mood or personality, visual hallucinations and alternations in smell, taste or tactile senses could signal a brain tumor or other abnormality.
Sometimes a single physical sign can broaden a clinician's diagnostic thinking. Manhattan psychiatrist Drew Ramsey recalled that early in his career, he examined a patient with daily panic attacks and noticed a swelling on her shins, a classic sign of Graves' disease, a form of overactive thyroid that can cause severe anxiety.
Like other psychiatrists, Dr. Ramsey said he always takes a medical history and orders blood tests for patients. He found that one was anemic and improved markedly when meat was added to her diet. Another who was depressed and drinking heavily was low on vitamins D and B-12.
Similarly, Dr. Schildkrout once treated a 50-year-old woman for mood swings and noticed a slight slurring to her speech. While it could have been dismissed as ill-fitting dentures, it turned out to be the first sign of amyotrophic lateral sclerosis, which also causes severe fatigue and odd jags of laughing and crying in its early stages.
Some patients may benefit from both psychological counseling and medical help. Therapists need not turn patients away while medical issues are being explored, experts say. "Clinicians can say, 'While we work on these issues, let's also discuss any possible medical conditions that could be contributing, so we can at least rule them out,"' Dr. Pollak said.
Finally clarifying a diagnosis can be a relief to clinicians and patients—particularly when therapy hasn't been working or patients have spent years blaming themselves. "When you find the right diagnosis, not only is there appropriate treatment, but it can make a dramatic improvement in terms of healing their self esteem," Dr. Schildkrout said.
—Email HealthJournal@wsj.com

Copyright ©2011 Dow Jones & Company, Inc. All Rights Reserved

Mass Attorney General Files Suit Against Ortho-McNeil-Janssen for Illegally Marketing Risperdal

MARTHA COAKLEY
ATTORNEY GENERAL
Press Release
August 01, 2011

BOSTON – Drug manufacturer Ortho-McNeil-Janssen (“Janssen”) is being sued by Attorney General Martha Coakley’s office for illegally marketing Risperdal, an atypical antipsychotic medication. The lawsuit alleges that Janssen promoted the drug to treat elderly dementia and a number of uses in children and adolescents when these uses had not been shown to be safe and effective and had not been approved by the U.S. Food and Drug Administration (“FDA”).

The complaint, filed in Suffolk Superior Court, further alleges that Janssen failed to disclose serious risks associated with Risperdal’s use, including the risk of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.

“Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Attorney General Coakley said. “Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing to disclose serious risks associated with Risperdal’s use.”

According to the Attorney General’s lawsuit, Janssen’s unfair and deceptive practices included:

Omitting and/or concealing material facts regarding Risperdal’s efficacy and safety in its communications with Massachusetts health care providers and consumers;

• Concealing, omitting or minimizing the side effects and risks associated with Risperdal’s use;
• Promoting Risperdal to treat elderly dementia without disclosing to prescribers the serious risks associated with Risperdal’s use in dementia patients, including an increased risk of death;
• Promoting Risperdal to treat elderly dementia without disclosing to prescribers that the U.S. Food & Drug Administration had rejected the company’s request to market Risperdal for this use because of unaddressed safety concerns;
• Promoting Risperdal’s use as safe and effective to treat conduct disorder and other conditions in children for more than a decade before receiving FDA approval to market Risperdal to treat any conditions in children;
• Making misleading and deceptive statements to prescribers about Risperdal’s safety, particularly with respect to weight gain and the risk of developing diabetes;
• Paying physicians to participate in sham consulting programs that were, in fact, thinly disguised marketing programs touting unapproved uses;
• Targeting its sales and marketing efforts to prescribers who rarely, if ever, prescribe Risperdal for its FDA-approved uses, primarily the treatment of schizophrenia and bipolar mood disorder.

Janssen’s illegal marketing and sales tactics helped the company generate hundreds of millions of dollars in sales in the Commonwealth, according to the complaint. Citing company documents, the lawsuit notes that these illegal tactics helped make Risperdal a market leader in both the children and adolescent and elderly market segments.

This matter is being handled by Assistant Attorneys General Sarah Ragland, Wendoly Langlois and Emiliano Mazlen, with assistance from division chief Thomas O’Brien and paralegal Marie Defer, all of the Attorney General Coakley’s Health Care Division.

Mass. aims to cut drug overuse for dementia Effort targets nursing homes

The Boston Globe
By Kay Lazar
November 18, 2010

State regulators and the Massachusetts nursing home industry are launching a campaign today to reduce the inappropriate use of antipsychotic medications for residents with dementia — a practice that endangers lives and is more common here than in most other states.

During the next year, a team of specialists will identify nursing homes with successful methods for avoiding overuse of antipsychotics and determine which homes need help cutting back. Nursing home staff will be taught how to deal with aggressive and difficult behaviors, often displayed by dementia patients, without resorting to antipsychotics to sedate them.

In 2009, 22 percent of Massachusetts nursing home residents who received antipsychotic medications did not have a diagnosis for which the drugs were recommended — the 12th highest rate of inappropriate antipsychotic use in the nation, the Globe re ported earlier this year.

Twice in the past five years, federal regulators have issued nationwide alerts about troubling and sometimes fatal side effects when antipsychotics are taken by people with dementia, often Alzheimer’s patients.

Specialists say that understaffing sometimes prompts overuse of these medications to help control dementia patients’ behavior, but that inappropriate use can also be traced to lack of training in alternative approaches.

“There is a knowledge gap between the front-line workers — the nurses — and the black-box warnings on these medications,’’ said Laurie Herndon, a geriatric nurse practitioner who is leading the initiative for Massachusetts Senior Care, the trade group representing the state’s 430 nursing homes. A black-box warning is the most serious type of caution used in prescription drug labeling.

“We wanted to avoid talking at them, and instead provide educational material they can use,’’ Herndon said.

Campaign details will be unveiled at the association’s annual meeting today in Worcester, which is expected to draw about 900 people.

Alice Bonner, the state’s top nursing home regulator, said she appointed a task force to study the overuse of antipsychotics in nursing homes and develop alternative approaches after the Globe highlighted the problem in Massachusetts earlier this year. The task force includes nursing home physicians, nurses, social workers, and pharmacists, along with elder advocates, researchers, and state surveyors who monitor the quality of the facilities.

Bonner, director of the Bureau of Health Care Safety and Quality in the Department of Public Health, said the state, given its budget problems, does not have new resources to devote to the campaign, but is working with legislators and the Patrick administration to get new funding in the next state budget. The trade association intends to apply for grants from nonprofit groups to fund the initiative.

“No one is going to plunk a whole lot of money in our laps,’’ Herndon said, “but that shouldn’t stop us.’’

Bonner said that the task force has already identified low-cost approaches used by some nursing homes. One approach involves more careful screening of patients when they are admitted, which includes gathering more detailed information from families about the patient’s personality before the onset of illness. This, Bonner said, helps staffers tailor care and activities to each patient.


“They get a good sense of who a person was before they began to suffer with dementia, what kinds of things they like to do, and what kinds of things their family can tell us makes them calm or gets them engaged,’’ Bonner said.

“When you see a nursing home with a low rate of antipsychotics, very often you will see these programs,’’ she said.

Bonner also said that nursing homes that give workers consistent schedules that allow them to work with the same patients have also been successful.

“That helps reduce difficult behaviors with patients with dementia because staff knows the patients so well, they pick up on early signs of trouble and prevent a catastrophic event, so they can intervene early,’’ she said. Consistent schedules have the side benefit of helping nursing homes retain their workers longer, Bonner said. “Once this is in place, it turns out it is less expensive because staff turnover is expensive,’’ she said.

The education campaign will draw on the work of Dr. Susan Wehry, a geriatric psychiatrist and associate professor of psychiatry at the University of Vermont College of Medicine. Wehry recently concluded an intensive, nine-month pilot project in four Vermont nursing homes that taught all staffers, from housekeepers to medical directors, alternative approaches, such as using music and massage, to manage difficult patient behaviors.

The program, she said, helped identify which alternatives work, which don’t, and how challenging the mission can be.

Wehry is still analyzing the results but said preliminary findings showed that in one of the homes where the administrator made all of the training sessions mandatory for staff, antipsychotic use was dramatically reduced. A third of the patients with dementia had been prescribed antipsychotics before the program, and not one was on them by the end, she said.

“They were much improved in terms of staff-resident interactions and level of alertness,’’ Wehry said. “And they looked happier.’’

Data from another home that did not make all of the training mandatory showed no change in the number of dementia patients given the medications. Wehry said a more troubling trend also emerged there — one of the physicians switched from giving antipsychotics to prescribing antianxiety medications.

“If all we do is shift the burden, then all we have done is create a different set of problems,’’ Wehry said. “Our goal is not to just reduce our reliance on antipsychotics, but to change [patient] behaviors.’’

Bonner said that the task force has already identified low-cost approaches used by some nursing homes. One approach involves more careful screening of patients when they are admitted, which includes gathering more detailed information from families about the patient’s personality before the onset of illness. This, Bonner said, helps staffers tailor care and activities to each patient.


“They get a good sense of who a person was before they began to suffer with dementia, what kinds of things they like to do, and what kinds of things their family can tell us makes them calm or gets them engaged,’’ Bonner said.

“When you see a nursing home with a low rate of antipsychotics, very often you will see these programs,’’ she said.

Bonner also said that nursing homes that give workers consistent schedules that allow them to work with the same patients have also been successful.

“That helps reduce difficult behaviors with patients with dementia because staff knows the patients so well, they pick up on early signs of trouble and prevent a catastrophic event, so they can intervene early,’’ she said. Consistent schedules have the side benefit of helping nursing homes retain their workers longer, Bonner said. “Once this is in place, it turns out it is less expensive because staff turnover is expensive,’’ she said.

The education campaign will draw on the work of Dr. Susan Wehry, a geriatric psychiatrist and associate professor of psychiatry at the University of Vermont College of Medicine. Wehry recently concluded an intensive, nine-month pilot project in four Vermont nursing homes that taught all staffers, from housekeepers to medical directors, alternative approaches, such as using music and massage, to manage difficult patient behaviors.

The program, she said, helped identify which alternatives work, which don’t, and how challenging the mission can be.

Wehry is still analyzing the results but said preliminary findings showed that in one of the homes where the administrator made all of the training sessions mandatory for staff, antipsychotic use was dramatically reduced. A third of the patients with dementia had been prescribed antipsychotics before the program, and not one was on them by the end, she said.

“They were much improved in terms of staff-resident interactions and level of alertness,’’ Wehry said. “And they looked happier.’’

Data from another home that did not make all of the training mandatory showed no change in the number of dementia patients given the medications. Wehry said a more troubling trend also emerged there — one of the physicians switched from giving antipsychotics to prescribing antianxiety medications.

“If all we do is shift the burden, then all we have done is create a different set of problems,’’ Wehry said. “Our goal is not to just reduce our reliance on antipsychotics, but to change [patient] behaviors.’’

Nursing Home Drug Use Puts Many at Risk, Antipsychotics given to some with dementia

The Boston Globe
By Kay Lazar, Globe Staff
March 8, 2010

Nearly 2,500 nursing home residents in Massachusetts were given powerful antipsychotic drugs last year that were not intended or recommended for their medical condition, a practice that is more common here than in most other states, according to a Globe analysis of federal data.

Data collected by the federal Centers for Medicare and Medicaid Services show that 28 percent of Massachusetts nursing home residents were given antipsychotics in 2009. Of that group, 22 percent - or 2,483 - did not have a medical condition that calls for such treatment.

That rate was the 12th highest in the nation, according to the federal data.

The use of such drugs is especially worrisome in nursing homes because a substantial number of residents suffer from dementia, a condition that puts them at greater risk of death when given antipsychotic medications.

The drugs, also known as “‘psychotropics,’’ were developed to treat people with severe mental illnesses such as schizophrenia, not dementia, which is the progressive loss of memory or other intellectual function than can result from aging or Alzheimer’s disease.

Twice in the past five years, federal regulators have issued nationwide alerts about troubling and sometimes fatal side effects when antipsychotics are taken by people with dementia, including increased confusion, sedation, and weight gain.

Scott Plumb, senior vice president of the Massachusetts Senior Care Association, the trade group representing the state’s 440 nursing homes, said Massachusetts’ consistent ranking as one of the heaviest users of psychotropic drugs indicates much more training is needed in nursing homes.

“We recognize the number is too high,’’ Plumb said, “and we are working to try to bring it down.’’

As the nation ages - up to 14 million baby boomers are expected to develop Alzheimer’s disease or a similar dementia - the drugging of such vulnerable patients takes on increasing urgency. While there has been much focus on the increasing use of antipsychotic drugs among children - highlighted by the recent overdose death of 4-year-old Rebecca Riley - much less attention has been paid to the similar problem among seniors.

“Way too many patients in nursing homes are treated with antipsychotics purely to sedate them or to control behaviors that are difficult for the staff,’’ said Robert A. Stern, an Alzheimer’s specialist and brain researcher at Boston University School of Medicine.

“To the defense of nursing homes and nursing home staff,’’ Stern said, “they are indeed understaffed, they are indeed under-trained, and it takes an awful lot of well-trained people to manage the difficult behaviors that can be exhibited by people with dementia.’’

While there is no barometer for what is considered an appropriate amount of antipsychotic use in nursing homes - and there is no law governing the matter - specialists in caring for the elderly note that the use of antipsychotics is much lower in some homes than others, and in some states than others.

They also point to the federal government’s recent legal action against the largest provider of drugs to nursing homes in the United States. The company, Omnicare, agreed in November to pay $98 million to settle charges that it took kickbacks from Johnson & Johnson to recommend the drug maker’s products, including the antipsychotic Risperdal. The government said Omnicare persuaded physicians to prescribe the medication to dementia patients with behavioral problems. A government suit against J&J is pending.

Specialists say antipsychotics can improve the quality of life for some dementia patients who suffer from extreme agitation and sleeplessness, common symptoms of Alzheimer’s. But too often nursing homes don’t regularly reevaluate patients’ medications to determine whether the antipsychotics are, in fact, effective and whether the dose can be lowered or eliminated, said psychologist Paul Raia, vice president of clinical services for the Massachusetts and New Hampshire Alzheimer’s Association.

Raia helps train nursing home staff in behavior management techniques that can ease agitation and the need for the drugs - skills and training that, specialists say, are often lacking in nursing homes in Massachusetts and across the country. In these homes, he said, as many as 80 percent of the residents are on antipsychotic drugs.

“And then I walk into a good place, one with training, and see 2 or 3 percent on these medications,’’ he said.

A nursing home’s track record for antipsychotic use often is a good predictor for future patients, according to new research from the University of Massachusetts Medical School. The scientists analyzed data from 1,257 nursing homes nationwide and found that patients newly admitted to facilities with some of the highest rates for prescribing antipsychotics are 37 percent more likely to receive the drugs than patients entering homes with the lowest prescribing rates.

Nicki Solomon of Norwood has seen those highs and lows. In 2007, she placed her mother, Corinne, in a nursing home. Although the retired surgical nurse suffered from dementia, she was still able to feed herself and converse clearly, but she had lost her short-term memory, was sometimes agitated and anxious, and would wander off.

Solomon said the nursing home, High Gate Manor in Dedham, asked her permission to prescribe her mother an antipsychotic but didn’t explain the potential side effects. Within weeks, Solomon said, her mother was transformed into someone she didn’t know.

“My mother was out of it all the time. She was asleep and noncommunicative,’’ Solomon said. “She was smothered.’’

She had been given Seroquel, Solomon said, one of the drugs that federal regulators months later would specifically warn against for dementia patients.

High Gate, citing patient confidentiality laws, declined to comment on Solomon’s care.

In June 2008, Solomon transferred her mother to a Needham nursing home that specializes in using alternatives to medication in caring for dementia patients. Her mother rebounded, she said, living another 15 months before her death last November.

Alice Bonner, the state’s top nursing home regulator as director of the Bureau of Health Care Safety and Quality, said “culture change,’’ including a growing consumer movement that focuses on more closely involving families and patients in care decisions, can lower the use of psychotropic drugs.

“We can do better, and use fewer drugs, and do more with behavioral interventions by changing the way we deliver care in nursing homes,’’ she said. Her agency is developing a brochure for nursing homes to give new residents and their families, encouraging them to ask y about the medications prescribed.

For Sharlene Hemp, a North Andover resident who says her father died from side effects of psychotropic drugs just 34 days after entering a nursing home, the answer is legislation. Her father had Alzheimer’s, but she said the family was never told about the medications nor of the potential lethal side effects, until after his death in 2001.

Hemp persuaded her state senator, Steven A. Baddour, to file legislation that would require all Massachusetts nursing homes and their prescribing physicians to obtain written permission from a patient’s health care proxy, which is often a family member, and a court appointed guardian before using antipsychotic medications. A public hearing was held on the bill in January, and it remains in committee.

“When you put a loved one in a nursing home, you are putting your trust in the nursing home and the doctor,’’ Hemp said. “But you don’t know when they go in that they are given all these drugs, and especially dementia patients, because they can’t tell you what they are given.’’

Kay Lazar can be reached at klazar@globe.com.
© Copyright 2010 The New York Times Company

Lilly ghostwrote Zyprexa studies, documents show

Fierce Pharma

June 12, 2009

By Tracy Staton

Eli Lilly prodded doctors to prescribe Zyprexa for dementia patients even though it had data showing the drug didn't help those patients, Bloomberg reports, based on internal company documents made public as part of a lawsuit. Plus, the company "ghostwrote" journal articles supporting the atypical antipsychotic, then scouted for doctors to append their bylines, the documents show. Lilly also compiled a guide to hiring scientists to write favorable articles.

Aggrieved by the document release, Lilly defended itself: "Plaintiffs are releasing one-sided, cherry-picked documents obtained in discovery to selected news media in an effort to try their cases in the media," Lilly spokeswoman Marni Lemons told Bloomberg, adding that the company will fight the lawsuit. She wouldn't answer specific questions, however.

The unsealed documents were submitted as evidence in lawsuits against the drugmaker, filed by health insurance companies and pension plans that want to be repaid for their spending on Zyprexa. The plaintiffs are asking for as much as $6.8 billion in damages. Lilly already settled off-label marketing claims with the U.S. government and several states--for $1.42 billion, including a $615 million criminal penalty. The company has paid $1.2 billion to settle individual patient claims, Bloomberg reports. For comparison's sake, Zyprexa sales for 2008 amounted to $4.69 billion, down slightly from $4.76 billion in 2007.