Monthly Archives: June 2008

Panel to review Medicaid guidelines for antipsychotic drugs

Daytona Beach News Journal
Staff Writer

A panel named this month to discuss changing state guidelines on paying for antipsychotic drugs for children will meet for the first time June 25.

At stake is the future treatment of more than 18,000 children in Florida currently receiving atypical antipsychotics medication for conditions ranging from ADHD to bipolar disorder and schizophrenia.

The number of children in the Florida Medicaid program prescribed the powerful drugs has nearly doubled from 9,364 kids in 2000 to 18,137 in 2006, the Daytona Beach News-Journal reported in January.

Among those children, the most common primary diagnosis was attention deficit hyperactivity disorder (ADHD) — an ailment not approved for treatment with antipsychotics by the Food and Drug Administration or by experts on the disease.

Medicaid will pay for a drug only if it is “medically necessary and prescribed for medically accepted indications,” according to current state guidelines.

Former Florida Agency for Health Care Secretary Dr. Andrew Agwunobi created the review group in January. The panel’s 11 members were announced this month, and officials said their recommendations will be presented to the agency’s Pharmaceutical and Therapeutic Committee after the June 25 meeting.

Dr. Lisa Cosgrove, a Merritt Island pediatrician who is a member of the review group and committee, said she will rely on a state-funded study by the Medicaid Drug Therapy Management Program for Behavioral Health at the University of South Florida when making recommendations. “It’s a good baseline model to follow,” she said.

During that 2005 study, a panel of experts recommended that antipsychotics (some of these drugs include: Risperdal, Seroquel, Zyprex, Abilify and Geodon) should not be used primarily to target ADHD, nor should antipsychotics be given to children younger than age 6 except under the most extraordinary circumstances.

The review group’s meeting will be 12:30 to 1:30 p.m. June 25 via teleconference.


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Florida Reporters Win Award for Antipsychotic Stories

Florida Society of Newspaper Editors
First Place
Robert Farley & Kris Hundley
St. Petersburg Times

“Drugs to Market”
Tackling a subject of national importance, the Times raised questions about the way the Food and Drug Administration licenses drugs. The pieces chronicled financial conflicts involving doctors and firms that cast doubt on the impartiality of the clinical trials that are the key feature of drug licensing.

You can find their articles here: St. Pete Times

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State may limit paying for some kids drugs

Miami Herald

The state’s healthcare agency is considering limiting payments for strong drugs prescribed to young children for illnesses such as autism and bipolar disorder.


TALLAHASSEE — Florida’s massive healthcare agency may cut back on paying for powerful drugs now prescribed for young children, although a final decision could be weeks or months away.

Since late April, the Agency for Health Care Administration has required doctors to obtain permission before the state’s Medicaid program will pay for drugs prescribed to children under the age of six for autism, bipolar disorder or attention deficit hyperactivity disorder. Any new prescriptions must be evaluated by psychiatrists at the University of South Florida in Tampa.

The reason for the change: the increase in the number of children prescribed the drugs in the past several years, especially since the U.S. Food and Drug Administration does not recommend anymore the use of what are known as ”atypical antipsychotic” drugs in young children. Previous published reports have said that the number of children in Medicaid getting such drugs has grown from more than 9,000 kids in 2000 to more than 18,000 in 2006.

A state panel met Wednesday to consider whether Florida should craft a more detailed policy to decide when it should pay for such drugs. The meeting drew a smattering of attendance, in person and on the phone, including a representative of the Citizens Commission on Human Rights, an offshoot of the Church of Scientology, who said the state was violating its own rules by paying for drugs not recommended by the FDA.

Dr. Jerome Isaac, a Bradenton pediatrician on the panel, questioned whether the state was pushing the issue to save money, saying that Medicaid should pay for a medication if it is recommended by a doctor.

”I see this as a cost-containment measure by putting obstacles in the way of physicians,” Isaac said.

Others on the panel disagreed, saying that at a minimum the state should consider refusing to pay for any new prescriptions unless the child has previously been evaluated by a psychiatrist.

Anne Wells, the Medicaid Pharmacy Services bureau chief, said state officials were ”parents” and ”pharmacists” and that the right policy for children is a “bigger issue than cost containment.”


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Doctors Say Medication Is Overused in Dementia

New York Times

Ramona Lamascola with her mother, Theresa Lamascola.

Ramona Lamascola thought she was losing her 88-year-old mother to dementia. Instead, she was losing her to overmedication.

Last fall her mother, Theresa Lamascola, of the Bronx, suffering from anxiety and confusion, was put on the antipsychotic drug Risperdal. When she had trouble walking, her daughter took her to another doctor — the younger Ms. Lamascola’s own physician — who found that she had unrecognized hypothyroidism, a disorder that can contribute to dementia.

Mrs. Lamascola no longer takes antipsychotics.

Theresa Lamascola was moved to a nursing home to get these problems under control. But things only got worse. “My mother was screaming and out of it, drooling on herself and twitching,” said Ms. Lamascola, a pediatric nurse. The psychiatrist in the nursing home stopped the Risperdal, which can cause twitching and vocal tics, and prescribed a sedative and two other antipsychotics.

“I knew the drugs were doing this to her,” her daughter said. “I told him to stop the medications and stay away from Mom.”

Not until yet another doctor took Mrs. Lamascola off the drugs did she begin to improve.

The use of antipsychotic drugs to tamp down the agitation, combative behavior and outbursts of dementia patients has soared, especially in the elderly. Sales of newer antipsychotics like Risperdal, Seroquel and Zyprexa totaled $13.1 billion in 2007, up from $4 billion in 2000, according to IMS Health, a health care information company.

Part of this increase can be traced to prescriptions in nursing homes. Researchers estimate that about a third of all nursing home patients have been given antipsychotic drugs.

The increases continue despite a drumbeat of bad publicity. A 2006 study of Alzheimer’s patients found that for most patients, antipsychotics provided no significant improvement over placebos in treating aggression and delusions.

In 2005, the Food and Drug Administration ordered that the newer drugs carry a “black box” label warning of an increased risk of death. Last week, the F.D.A. required a similar warning on the labels of older antipsychotics.

The agency has not approved marketing of these drugs for older people with dementia, but they are commonly prescribed to these patients “off label.” Several states are suing the top sellers of antipsychotics on charges of false and misleading marketing.

Ambre Morley, a spokeswoman for Janssen, the division of Johnson & Johnson that manufactures Risperdal, would not comment on the suits, but said: “As with any medication, the prescribing of a medication is up to a physician. We only promote our products for F.D.A.-approved indications.”

Nevertheless, many doctors say misuse of the drugs is widespread. “These antipsychotics can be overused and abused,” said Dr. Johnny Matson, a professor of psychology at Louisiana State University. “And there’s a lot of abuse going on in a lot of these places.”

Dr. William D. Smucker, a member of the American Medical Directors Association, a group of health professionals who work in nursing homes, agreed. Though the group encourages doctors to conduct a thorough assessment and prescribe antipsychotics only as a last resort, he said, “Many physicians are absent without leave in the nursing home and don’t take an active role in the assessment of the patient.”

Some nursing homes are trying a different approach, so-called environmental intervention. The strategies include reducing boredom, providing intellectual and physical stimulation, exercise, calming music, bringing in pets for therapy and improving how the staff approaches and talks to dementia patients.

At the Margaret Teitz Nursing and Rehabilitation Center in Queens, social workers do life reviews of patients to understand their interests, lifestyle and former occupations.

“I had a patient who used to be in fashion,” said Nancy Goldwasser, the director of social services. “So we got her fabric samples. And she’d sit and look through the books, touch the fabric, and it would calm her.”

But such approaches are time consuming, they do not help all patients, they can be prohibitively expensive and they will be more difficult to provide as Alzheimer’s continues to increase.

“Our health care system isn’t set up to address the mental, emotional and behavioral problems of the elderly,” said Dr. Gary S. Moak, president of the American Association for Geriatric Psychiatry.

Nursing homes are short staffed, and insurers do not generally pay for the attentive medical care and hands-on psychosocial therapy that advocates recommend. It is much easier to use sedatives and antipsychotics, despite their side effects.

The first generation of antipsychotics, like Haldol, carry a significant risk of repetitive movement disorders and sedation. Second-generation antipsychotics, also called atypicals, are more commonly prescribed because the risk of movement disorders is lower. But they, too, can cause sedation, and they contribute to weight gain and diabetes.

Used correctly, the drugs do have a role in treating some seriously demented patients, who may be incapacitated by paranoia or are self-destructive or violent. Taking the edge off the behavior can keep them safe and living at home, rather than in a nursing home.

If patients are prescribed an antipsychotic, it should be a very low dose for the shortest period necessary, said Dr. Dillip V. Jeste, a professor of psychiatry and neuroscience at the University of California, San Diego.

It may take a few weeks or months to control behavior. In many cases, the patient can then be weaned off of the drugs or kept at a very low dose.

Some experts say another group of medications — antidementia drugs like Aricept, Exalon and Menamda — are underused. Research shows that 10 to 20 percent of Alzheimer’s patients had noticeable positive responses to the drugs, and 40 percent more showed some cognitive improvement, even if it was not noticeable to an observer.

“Sometimes, it’s enough to take the edge off the behavioral problems, so the family and patient can live with it and you don’t expose people to much risk,” said Dr. Gary J. Kennedy, director of geriatric psychiatry at the Montefiore Medical Center in the Bronx.

Other experts cite a lack of research backing these drugs for behavioral problems.

If patients begin showing behavioral symptoms of dementia, doctors said, they should have complete medical and psychiatric workups first, especially if symptoms develop suddenly.
“Just because someone is 95 does not mean one should not do a workup, especially if she’s been healthy,” Dr. Kennedy said.

Common causes of the symptoms include ministrokes, reparable brain hemorrhage from a mild bump on the head, hypothyroidism, dehydration, malnourishment, depression and sleep disorders.

Some doctors point out that simply paying attention to a nursing home patient can ease dementia symptoms. They note that in randomized trials of antipsychotic drugs for dementia, 30 to 60 percent of patients in the placebo groups improved.

“That’s mind boggling,” Dr. Jeste said. “These severely demented patients are not responding to the power of suggestion. They’re responding to the attention they get when they participate in a clinical trial.

“They receive both T.L.C. and good general medical and humane care, which they did not receive until now. That’s a sad commentary on the way we treat dementia patients.”

To family members looking at a nursing home for an aging parent, experts recommend seeking out homes with low staff turnover, a high ratio of staff members to patients, and programs with psychosocial components.

The Medicare Web site has basic information on individual homes at The National Citizens’ Coalition for Nursing Home Reform, at, offers a consumer guide to choosing a nursing home.

If medications are necessary, a family member should communicate with the prescribing doctor, learn the goal of each medication and be involved in making the decision.

Dr. Moak, of the psychiatry association, emphasized seeking out the doctor. Family members, he said, “often speak through the nursing staff, and that’s a huge mistake.”

Family members who are not convinced that a relative is receiving the best care should get a second opinion, as Ramona Lamascola did.

The physician she consulted, Dr. Kennedy of Montefiore, stopped her mother’s antipsychotics and sedatives and prescribed Aricept.

“It’s not clear whether it was getting her hypothyroid and other medical issues finally under control or getting rid of the offending medications,” he said. “But she had a miraculous turnaround.”

Theresa Lamascola still has dementia, but she went from confinement in a wheelchair — unable to sit still and screaming out in fear — to being able to walk with help, sit peacefully, have some memory and ability to communicate, understand subtleties of conversations and even make jokes.

Or, as her daughter put it, “I got my mother back.”

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Inappropriate prescribing ‘cutting lives short’

The Guardian
Sarah Boseley, health editor

The use of so-called “chemical cosh” antipsychotic drugs to subdue people with dementia will be curbed as part of a government strategy to help the growing numbers of people with the condition.

In an interview with the Guardian the social care minister, Ivan Lewis, made it clear he was unhappy with the number of dementia patients, usually in care homes, who are being heavily sedated, with risks to their health. “I’m really perturbed by this question of the inappropriate prescribing of drugs,” he said. “We sometimes dehumanise stories like this – it is my or your mum and dad who is being over-medicated.”

Lewis, who has pledged “to drag dementia out of the dark ages”, announced an immediate review of the use of the drugs, which according to the Alzheimer’s Society are being inappropriately given to an estimated 100,000 people. It will look at the use of drugs generally to change the behaviour of people who may be agitated because of their condition, and at why GPs were prescribing two drugs in particular – the atypical antipsychotics risperidone and olanzapine – to so many dementia patients in the face of official guidance that they should not be used.

As long as ago as 2004 the Medicines and Healthcare Products Regulatory Authority (MHRA) restricted the prescribing of these drugs because of evidence that dementia patients taking them were three times as likely to suffer a stroke. The dangers, said the MHRA, “outweigh the likely benefits in the treatment of behavioural symptoms of dementia”.

Liberal Democrat MP Paul Burstow, who campaigns on this issue, said immediate action was necessary and pointed out that the authorities in the United States had put a “black box” warning on the drugs. “The evidence is already compelling: these drugs don’t treat dementia, they cut lives short,” he said. Lewis said the review was needed because there were circumstances in which the prescription of the drugs for dementia patients might be necessary.

Professor Sube Banerjee, consultant in old-age psychiatry at the Maudsley hospital in London, who is advising the department on the dementia strategy, said it was not easy to tell who was overprescribing, but “the reality is that the scale of the prescription makes it clear that these aren’t just the exceptions we are seeing”. There are alternatives to drugs for managing patients’ agitation, he said. Early diagnosis and training doctors, nurses and care staff to help and manage patients was key.

Neil Hunt, chief executive of the Alzheimer’s Society, said the drugs worsened the problems dementia patients were suffering, reducing their mobility and their grip on reality.

The review will report in September, to coincide with the official launch of the national dementia strategy which, in its consultation form published yesterday, has three aims: to increase awareness of dementia and remove the stigma of it, to ensure early diagnosis and intervention, and to improve the quality of care people receive.

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Florida Seroquel Case – AstraZeneca CEO Deposed

The News Journal
Astra CEO in London trial will take stand
AstraZeneca faces 8,440 cases over Seroquel risks
By Andrew Eder

The chief executive of AstraZeneca is set to be deposed today regarding allegations the company hid the risk that its anti-psychotic drug Seroquel could cause diabetes in users.

David Brennan, who led AstraZeneca’s U.S. unit in Fairfax before being appointed CEO of the London-based drug maker in 2006, will answer questions in London from attorneys representing thousands of plaintiffs across the Unites States.

“A lot of very good people have been severely injured for the rest of their life because of the conduct of this company and the effect of this drug,” said attorney Paul Pennock of the New York firm Weitz & Luxenberg, which is handling about 2,500 Seroquel cases in federal and state courts.

In all, AstraZeneca said it faces 8,440 personal injury lawsuits from more than 12,000 plaintiffs over Seroquel, a drug developed in Delaware by AstraZeneca’s corporate predecessor Zeneca Group.

The lawsuits include a consolidated case in federal court in Florida, for which Brennan is giving his deposition, as well as clusters of state court cases in Delaware, New Jersey, New York and Missouri. Pennock said the first cases are likely to go to trial next spring.

AstraZeneca said Seroquel, part of a class of drugs known as atypical anti-psychotics, has helped millions of people suffering from mental illnesses lead healthy lives.

The company said the nature of the plaintiffs’ alleged injuries is unclear and little or no information about the alleged injuries was provided in the complaints.

“AstraZeneca intends to litigate these cases on the merits and will defend the cases vigorously,” company spokesman Tony Jewell said.

Pennock said the team of plaintiffs’ attorneys, from several law firms across the country, believes the evidence at trial will show that AstraZeneca knew Seroquel could potentially cause high blood sugar levels, weight gain and diabetes; that the company hid the dangers; and that it avoided studying the issue to limit evidence of the risks.

AstraZeneca added a warning about the risk of hyperglycemia and diabetes to Seroquel’s label in 2004 at the urging of the U.S. Food and Drug Administration.

Pennock said as many as 70 percent of Seroquel prescriptions were for “off-label” uses, meaning the FDA has not approved the drug for those uses. Seroquel is approved for the treatment of schizophrenia and bipolar disorder, but AstraZeneca is asking the FDA also to approve its once-daily version of the drug, Seroquel XR, for depression and anxiety disorder.

At least three states, including Pennsylvania, have sued AstraZeneca over its marketing of Seroquel, the company’s No. 2 drug with more than $4 billion in sales last year.
Jewell said AstraZeneca promotes its medications in accordance with FDA regulations. Doctors are free to prescribe medications as they see fit.

“That’s their decision based on their medical judgment about the needs of their patients,” Jewell said.

Eli Lilly & Co. has paid at least $1.2 billion to settle product liability claims with more than 31,000 people over Zyprexa, another atypical antipsychotic. AstraZeneca said in a financial filing in January that it had incurred legal costs of about $200 million, and that it expects its product liability insurance to cover its legal costs in the cases.

Pennock, who said AstraZeneca’s attorneys have refused to discuss a settlement, said he thought Seroquel litigation could cost the drug maker as much as $10 billion.

On Thursday, Pennock’s firm released information on a lawsuit filed in New Jersey on behalf of a New York City paramedic who was injured at the World Trade Center on Sept. 11, 2001.

The law firm said the paramedic was prescribed Seroquel for post-traumatic stress disorder and later developed type 2 diabetes.

“His case is emblematic of the problem,” Pennock said.

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Doctors’ prescriptions need dose of disclosure

Chicago Sun Times

When your doctor gives you a prescription, you expect full disclosure and a little straight talk.

Full disclosure on the research behind the drug.

Straight talk from your doctor on why he is recommending this drug over another.

But far too often, that full disclosure and straight talk are deeply compromised by money and perks from your friendly global drug company, though you may never know. Recent reports reveal that drug companies quietly pay billions of dollars to the medical researchers who study new drugs and the doctors who prescribe them.

Three prominent psychiatrists at Harvard Medical School and an affiliated hospital recently were caught greatly underreporting the amount of money that drug companies have put in their pockets over the years. Two of the researchers were paid $1.6 million each in consulting fees from drug companies between 2000 to 2007, while the third was paid more than $1 million — much of it never reported, as required, and revealed only after a congressional inquiry.

What’s particularly unsettling is that the researchers specialize in children with psychiatric problems, and they have been effective boosters of using strong antipsychotic drugs for treatment.

As for the doctors who do the prescribing, a survey published last year in the New England Journal of Medicine revealed that more than a third of the doctors had been reimbursed by drug and medical device companies for professional meetings or continuing education, and more than 25 percent got money for consulting, giving speeches or enrolling patients in medical trials.

A Senate bill, sponsored by Republican Sen. Charles Grassley and Democratic Sen. Herb Kohl, offers a reasonable antidote. It would require big drug and medical device companies to report payments to doctors that exceed $500 a year, information that would be posted online.

What a fine idea.

Given how much money drug companies throw around, a second opinion can’t hurt.

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