Thursday, January 13, 2011

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.’’

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Monday, December 13, 2010

A Legacy of Unintended Side Effects

The Boston Globe
Patricia Wen
Dec 12, 2010


First in a three-part series.

Geneva Fielding, a single mother since age 16, has struggled to raise her three energetic boys in the housing projects of Roxbury. Nothing has come easily, least of all money.

Even so, she resisted some years back when neighbors told her about a federal program called SSI that could pay her thousands of dollars a year. The benefit was a lot like welfare, better in many ways, but it came with a catch: To qualify, a child had to be disabled. And if the disability was mental or behavioral — something like ADHD — the child pretty much had to be taking psychotropic drugs.

Fielding never liked the sound of that. She had long believed too many children take such medications, and she avoided them, even as clinicians were putting names to her boys’ troubles: oppositional defiant disorder, depression, ADHD. But then, as bills mounted, friends nudged her about SSI: “Go try.’’

Eventually she did, putting in applications for her two older sons. Neither was on medications; both were rejected. Then last year, school officials persuaded her to let her 10-year-old try a drug for his impulsiveness. Within weeks, his SSI application was approved.

“To get the check,’’ Fielding, 34, has concluded with regret, “you’ve got to medicate the child.’’

There is nothing illegal about what Fielding did — and a lot that is perhaps understandable for a mother in her plight. But her worries and her experience capture, in one case, how this little-scrutinized $10 billion federal disability program has gone seriously astray, becoming an alternative welfare system with troubling built-in incentives that risk harm to children.

A Globe investigation has found that this Supplemental Security Income program — created by Congress primarily to aid indigent children with severe physical disabilities such as cerebral palsy, Down syndrome, and blindness — now largely serves children with relatively common mental, learning, and behavioral disorders such as ADHD. It has also created, for many needy parents, a financial motive to seek prescriptions for powerful drugs for their children.

And once a family gets on SSI, it can be very hard to let go. The attraction of up to $700 a month in payments, and the near-automatic Medicaid coverage that comes with SSI approval, leads some families to count on a child’s remaining classified as disabled, even as his or her condition may be improving. It also leads many teenage beneficiaries to avoid steps — like taking a job — that might jeopardize the disability check.

The latest federal statistics, obtained by the Globe through a public records request, show a stunning rise over the past two decades in the number of children who qualify for SSI because of a variety of mental disabilities.

Of the 1.2 million low-income children nationwide who received SSI checks last year, 53 percent, or 640,000, qualified because of mental, learning, or behavioral issues, up from 8 percent in 1990. By significant margins, the top two disorders are Attention Deficit Hyperactivity Disorder, or ADHD, and delayed speech in young children, followed by autism spectrum disorders, bipolar illness, depression, and learning problems, according to the Social Security Administration, which runs this program and the $55 billion SSI system for adults.

In New England, the numbers are even higher — 63 percent of children qualify for SSI based on such mental disabilities. That is the highest percentage for any region in the country. And here and across the nation, the SSI trend line is up, with children under 5 the fastest-growing group. Once diagnosed, these children often bring in close to half their family’s income.

“This has become the new welfare,’’ said MIT economics professor David Autor. “This is a very valuable resource to families, but you’re providing incentives for them to produce a diagnosis for their children to be part of this program, and there’s also incentives to medicate them. This is a substantial public policy problem.’’

This transformation of the children’s SSI program is viewed as a victory by many disability and mental health advocates, who have long pressed for serious cases of depression and learning disorders to be recognized alongside cerebral palsy and Down syndrome as major disabilities. The program’s expansion has also undoubtedly helped many new families cope with the exhausting needs of deeply troubled children.

“A few years ago, we never saw a bipolar diagnosis in a child; now we do,’’ said David Rust, a top Social Security official who defended the agency’s handling of the SSI children’s program in an interview with the Globe. “The world is changing in terms of who we serve and the kinds of conditions we see.’’

But, the Globe review found, the changing nature of the SSI program has had some disturbing side effects. Many cash-strapped parents have come to believe that if only they can muster the necessary array of medical records, their children have a good shot at this benefit, even if it means carrying the stigma of the word “disabled.’’ And while some parents see their children’s behavior improve from psychotropic drugs — as has been the case so far with Fielding’s youngest boy — they bristle at the outsize role that these medications seem to them to play in securing SSI approval.

For many, the motivation to apply comes down to economics: SSI payments can be a lifeline in a bad economy, and they beat welfare checks in almost every way. For a Massachusetts parent with two children, welfare pays a maximum of about $600 a month. If one of those two children is approved for the SSI program, the total government benefit can be twice as much.

“Everybody’s poor, everyone’s got issues,’’ Fielding said, as she sat in her family’s apartment near Madison Park. “People are going to try to get a check.’’

Learning the system At the beginning of every month, postal carriers drop more than 21,000 SSI checks on behalf of children into mailboxes across Massachusetts, mostly in distressed areas of Springfield, Boston, Holyoke, Lawrence, and New Bedford. Only youngsters living around the poverty level are financially eligible, and many of their parents, out of work or maxed-out on welfare benefits, have grown resigned to homeless shelters and food pantries.

The children on SSI represent a cross section of the poor. Federal data show that roughly half identified as white, half as black; some 16 percent self-identified as Hispanic. Two of every three recipients are boys, in part because ADHD diagnoses skew heavily male. And ADHD is the top diagnosis, constituting 31 percent of all children on SSI for behavioral, learning, and mental disorders.

As the Globe investigated the surge in SSI cases — mostly by visiting housing projects, Social Security offices, and downtown districts — many parents were reluctant to talk, fearful of losing this coveted benefit. Still, some two dozen families agreed to be interviewed, in part to vent their frustration at what they perceive to be the government’s arbitrary approval process in mental disability cases. Some wanted only their first names to be used as they described their persistent efforts to figure out what Social Security wanted, and their growing conviction that medication for the child was a critical step.

Waiting on a bench in a rundown commercial strip of Lawrence, Yessenia was among the frustrated.

The 28-year-old woman said late last summer that she will be trying, for the third time, to obtain SSI payments for her 7-year-old son based on his ADHD symptoms: impulsivity and inattention.

Yessenia said she is convinced her son’s first two applications were rejected because she had nothing to list in the section labeled “medications.’’ But in recent months, she has convinced the boy’s doctor to write a prescription. Her son is now taking a stimulant often used for ADHD.

“If you child doesn’t have medications, the SSI office thinks he doesn’t have any big problem,’’ she said.

Yessenia and her extended family have long experience with the SSI program. As a child, she said, she qualified for SSI based primarily because of learning disabilities, and after her 18th birthday, she requalified as an adult on the same basis. Her older sister, diagnosed with bipolar disorder, has been receiving SSI benefits since childhood.

Yessenia said she has other reasons to be optimistic that her son’s new application will be approved.

“Since he was denied all the time, the therapist said she’d give him another diagnosis, and that’s when she said he’s got depression,’’ said the mother, who has yet to submit the new application. “She’s also recommending another drug.’’

Yessenia, and the others interviewed, insisted that they do only what is best for their children’s health and would never medicate purely to boost their SSI application. But some of the parents said they know of others who exaggerate their children’s symptoms so that clinicians prescribe medications or add additional psychiatric diagnoses.

“A lot of people do it,’’ said Makeysha, a Jamaica Plain mother whose child is on SSI for ADHD. “A lot of people don’t have income coming in.’’

A special education teacher at Holyoke High School with two decades of experience said it is clear to her that indigent parents learn, through word of mouth, the strategic “ins and outs’’ of the SSI system. The teacher, who asked not to be named because she is not authorized to speak about student records, said she has seen hundreds of teenagers on SSI for mental disabilities.

“I don’t know anyone who isn’t on drugs,’’ she said.

She also said she is frequently asked by parents to complete SSI paperwork about a child’s academic level, in hopes that it will confirm a diagnosis for some kind of mental disorder.

A horrifying case The incentives built into the SSI program and their potential hazards came into starkest relief in the case of a South Shore couple, Carolyn and Michael Riley.

Their story was horrifying and far from typical, but also telling about how a child’s mental health diagnosis can be abused in the name of money.

Each of their three children was, according to medical records, diagnosed with ADHD and bipolar disorder, and prescribed three powerful drugs. The parents made sure to highlight the youngsters’ prescription data in their SSI applications: “If not for medication, my son would not be able to sleep more than 3 hours in a 24-hour period,’’ Michael Riley wrote. The parents obtained SSI benefits for the oldest two children, and for themselves through the SSI program for adults. They were applying for benefits for 4-year-old Rebecca, when the girl turned gravely ill sometime after midnight on Dec. 13, 2006.

Rebecca had been sick with an respiratory infection, but the Rileys did not take her to a doctor. Instead, they fed her excessive amounts of clonodine, a sedating medication often prescribed for ADHD, to get her to sleep. She ultimately died of a drug overdose, and jurors this year convicted her parents of killing Rebecca with their reckless care. Records made public during the murder trials showed the parents’ casual approach to medication over years, and how their calculated pursuit of SSI checks and psychiatric pills caused them to exaggerate their children’s behaviors to clinicians, including a Tufts Medical Center psychiatrist.

Until the day Rebecca died, the family depended largely on SSI checks totaling roughly $30,000 a year.

As extreme as their case proved to be, the way this family sustained itself financially is far from rare. As more families are cut off from the nation’s welfare benefits, millions of indigent parents have turned to SSI.

Said Williams College economist Lucie Schmidt: “It’s become the de facto backup safety net.’’

Top officials in the Social Security Administration, in an interview this fall at the agency’s headquarters just outside Baltimore, insisted they do their best to implement the Congressional mandates for the SSI children’s program, which require sensitivity to a wide range of physical and mental disabilities, while approving only those children with severe impairments.

Art Spencer, associate commissioner in the agency’s office of disability programs, said he was disturbed to hear that the Globe’s review found that many indigent families are convinced that psychotropic drugs are critical in obtaining SSI benefits.

“Medication helps confirm a diagnosis, but most of the decision is going to be based on the child’s function,’’ said Spencer, whose agency’s primary job is overseeing the nation’s $800 billion program for retirees’ and other workers’ benefits.

Rust, deputy commissioner in the office of retirement and disability policy, said each child’s case is carefully reviewed by a disability examiner, as well as an in-house pediatrician.

He said that the agency does not currently track how many children on SSI are prescribed psychotropic medications, but that a new computerized record-keeping system may give them the ability to do so. Rust emphasized that, ultimately, awarding benefits rests largely on what the child’s doctors and clinicians say about the child’s impairment, and that the agency needs to trust that information. He said, on occasion, disability officials have spotted clusters of SSI families with the same doctors, and with strikingly similar diagnosis and treatments, and referred those for possible fraud prosecution. But mostly, he said, “We work off the medical evidence we get.’’

Rust, a former high school teacher, acknowledged, however, the risk that long-term SSI enrollment may exact a psychic toll.

“One of my concerns about the program is that by designating a child as being disabled, it creates a certain mindset with the child, with the family, with the schools… . You’re disabled. You are unable to do certain things,’’ he said. “I really do wor ry, in the program’s attempt to help children, and that’s what we’re trying to do, we can create a certain psychology of disability that is hard to break. ’’

A subjective scale It is easy to see why indigent families are confused by eligibility rules — and looking for a shortcut to SSI approval.

On paper, the eligibility requirements are daunting. According to the most recent Social Security rules, passed in 1996, a child can be approved for mental disability benefits only if he or she has a “medically determinable impairment that results in marked and severe functional limitations.’’ The impairment should be one that persists for at least a year or may result in death.

In some instances, a specific diagnosis for a severe condition — schizophrenia, for example — is a virtual and uncontroversial guarantee of benefits. But most diagnoses are not of that severity and SSI approval hinges on the highly subjective determination of whether a child’s condition, or cluster of conditions, amounts to a “severe’’ impairment.

Officials wade through piles of medical, clinical, pharmacy, and school records, some haphazardly or partially completed, to determine how a child functions in six designated “domains,’’ such as how well he or she communicates, or gets along with peers, or can take care of his or her own basic needs. One “marked’’ impairment is not enough for SSI approval, but a “severe’’ impairment in one domain, or, alternatively, “marked’’ impairments in two domains, is.

Officials may also rely on standardized neuropsychological and other tests or hire an independent medical expert to evaluate the child. Nevertheless, in many cases, diagnoses are based largely on a parent’s account, and disability evaluators never meet the child face-to-face.

Jennifer Erkulwater, a coauthor of the Harvard University Press book “Medicating Children,’’ about the rise of ADHD diagnoses nationwide, said it is easy to see how psychotropic drugs have turned into a potential marker of a mental disorder’s severity.

“If the doctor says it’s serious, he’s giving a prescription,’’ said Erkulwater, a political science professor at the University of Richmond.

She said it is unclear whether the SSI approval process is a factor behind federal data showing that indigent children are diagnosed and prescribed psychiatric drugs at a higher rate than more well-off children. A 2008 study found, for example, that 12 percent of children on Medicaid were diagnosed with ADHD, compared with 8 percent of children on private insurance. Other national studies using Medicaid data have found that poorer children with behavioral and mental diagnoses are also medicated with ADHD drugs and antipsychotic medications at higher rates.

Erkulwater said researchers have cited many explanations for this difference, including the possibility that doctors are more inclined to medicate poor children or that higher rates of mental disorders exist among the destitute. She said that “among the nexus of reasons’’ is that indigent families may be more open to psychotropic drugs if they believe a prescription will help a child’s SSI application.

Patrisha Thompson, a Fall River mother of two, cited another reason why poor families may be quicker to medicate their children for behavioral problems: They don’t have the time for bus or subway rides to talk-therapy sessions, and they know that counseling sessions are unlikely to impress a disability examiner.

Thompson, 28, said her job in the health care industry made her realize the importance of trying behavioral therapy. She took her sons to such sessions before agreeing reluctantly last year to let her sons start a prescription of an ADHD medication. She has since put in SSI applications for both boys, ages 7 and 10, whose diagnoses also include depression, anxiety, and learning disorders. But many indigent parents, she said, do not realize that there are alternatives to drugs, or don’t have the time to pursue them.

“It’s easier to medicate,’’ said Thompson, recounting what she hears from other parents.

Thompson is still waiting to hear how SSI rules on her oldest boy’s application. Her 7-year-old boy was denied, she said, adding that she was not given a reason.

She said the denial may indicate that drugs are not a decisive factor. But she said that, based on her knowledge of other cases, an application with no mention of drugs has “little to no chance’’ of success. Even if both sons’ applications are denied, she said, she is grateful that her job gives her enough income to provide the basics. But she can understand why others, more impoverished, seek SSI approval.

“Money determines everything,’’ she said. “It determines how much you eat, what you eat, and how you treat your kids.’’

Landmark ruling The federal disability program for poor children was born four decades ago, shortly after Congress rejected President Nixon’s groundbreaking 1969 proposal for a guaranteed minimum income for the poor.

Instead, as a compromise of sorts, federal lawmakers approved the Supplemental Security Income program for the elderly, as well as for blind and disabled adults. Some early drafts of the proposal made no mention of children. But at the 11th hour, and virtually as a footnote, lawmakers in 1972 designated disabled children eligible for SSI payments.

The idea was that the benefit would help replace wages lost by indigent parents as they took time out to care for children with severe physical and congenital disabilities, such as cerebral palsy, muscular dystrophy, and deafness, or those with life-threatening illnesses, such as cancer. The money was also seen as a way to help families with extra expenses, such as wheelchairs or taxi rides to hospitals.

It remained for many years a relatively small, highly restrictive program; as late as 1990, it served fewer than 300,000 children, and only 8 percent qualified based on behavioral or mental disorders.

Then, after a landmark legal ruling, the ground began to shift.

The case grew out of a campaign in the early 1980s under President Reagan to reduce SSI rolls. Social Security officials, responding to the new mandate, cut off Brian Zebley, a boy who had been receiving benefits since he was toddler, ruling that he was no longer disabled despite a variety of physical and intellectual disabilities. His family’s lawyer challenged the fairness of the eligibility rules, arguing they were too adult-oriented and rigid, and in 1990, the US Supreme Court agreed. Social Security authorities then rushed to implement new, looser rules, and also widened eligibility for children’s behavioral and learning disorders.

A subsequent spike in mental disability cases led to a national uproar. Media accounts described parents coaching their children to misbehave or flunk tests. Some of those who desired change wanted ADHD cut from the list of allowed SSI diagnoses, arguing that the condition was not typically severe, and that its inclusion was leaving the system vulnerable to an explosion of claims. But they were drowned out by advocates for the disabled. Meanwhile, some federal authorities raised concerns about the program’s potential to harm children.

“Here the moral hazard is that the family may become dependent on SSI, and in order to continue to receive payments, decline to seek treatment aggressively or fail to encourage a child to do his or her best to overcome a disability,’’ said Jim Slattery, a former congressman and chairman of the National Commission on Child Disability, during a 1995 hearing.

By the mid-1990s, federal lawmakers were cracking down.

Congress passed tougher standards for SSI mental disability disorders, saying a child now had to exhibit a “medically determinable’’ disability with “marked and severe’’ limitations. These changes were included as part of sweeping 1996 welfare reforms.

The children’s SSI disability rolls instantly shrunk — but the decline would be short-lived. Families and clinicians began to adjust to the new rules, which emphasized extensive medical records for any claimed disability. From 1997 to 2007, the number of children who qualified under behavioral, mental, and learning disorders more than tripled from 180,000 to 562,000. By last year, more than 639,000 children were on SSI, 53 percent of all cases.

This abrupt climb in cases is a sign, some researchers say, that the SSI program has veered far from its original purpose.

Dr. James Perrin, a Massachusetts General Hospital pediatrician who has served on federal panels evaluating the SSI program, defended the program, saying it cares for many of the most vulnerable youngsters. One of SSI’s main benefits, he said, is providing near-automatic Medicaid coverage for disabled children. But he said some aspects of the program may need to be reconsidered, including the no-strings-attached cash benefit.

“Families with children with disabilities have real needs for additional income - but perhaps that money should be linked to meeting the specific needs of the child’s disability and, where possible, to supporting that child’s transition to productive adult life.’’

‘Driven by the dollar’ The pressure on medical professionals to help families make the case for SSI approval can be considerable.

One nurse practitioner in a large urban clinic who asked to be unnamed because she is not authorized to speak about her patients said she recently faced the wrath of a parent whose 4-year-old child’s SSI benefits, granted at birth due to prematurity, were cut off because the child was much better now. The nurse said she had candidly filled out the SSI form about the child, saying the boy had caught up with his peers and had only “minimal deficits.’’ The mother was livid, shouting at her, “Don’t you think this child’s disabled?’’

“They get angry with us,’’ the nurse practitioner said.

One diagnosis she believes is seriously overused is “the whole vague developmental delay’’ category for young children, often preschoolers who are behaving badly at home or in day care for undetermined reasons. She said clinicians often attribute such behavior to developmental delay, especially if they are sympathetic to that family’s needs for SSI payments.

“It’s all driven by the dollar,’’ she said.

Many doctors, therapists, and social workers say they are well aware of the impact SSI benefits can have on indigent families. Indeed, some clinicians said they often feel pressure to upgrade a diagnosis or tailor the SSI paperwork to increase the odds of approval. Some say they go that extra mile because they believe that furthering the financial stability of needy families is essential in helping a troubled child.

“Some psychiatrists do feel these people are entitled to benefits,’’ said Judy Rolph, a pediatric psychiatric nurse in Boston for more 30 years. “You know these people are poor.’’

Also pushing hard for SSI approvals is the growing number of for-profit firms that specialize in helping poor families tap into SSI benefits. These companies, which call themselves “eligibility service providers,’’ are hired by hospitals, which stand to lose money when caring for uninsured patients. If these firms successfully obtain SSI benefits for an uninsured child, the youngster’s medical bills are paid by Medicaid. The reimbursement rates are even higher if the child is deemed disabled.

Health insurance companies, which administer Medicaid plans, also sometimes hire these firms, for similar financial reasons.

State welfare department officials also often urge poor families to apply for SSI benefits on behalf of their children. There, too, money is the motivation. An indigent child cannot be on both welfare and SSI at the same time, so states save money if a child goes on SSI, which is entirely paid for by federal funds. The cost of traditional welfare is covered by state and federal money.

Such help with the SSI application can be critical for parents, many of whom are at a loss to complete the complex paperwork.

Giselle Cabrera, a family services coordinator at the Head Start preschool in Holyoke, who helps families with SSI applications, sees firsthand how parents struggle to complete certain SSI forms and wonder how candid to be about their children’s symptoms. They are often desperate, she said, and often medication is what they believe will help their child’s case.

“It’s very frustrating for parents,’’ she said.

‘It’s all about surviving’ Sitting in her apartment near Madison Park, Geneva Fielding is surrounded by stacks of well-organized SSI files for her three sons. She continues to be torn about medicating her youngest. Tucked among her thick files is a favorite article, titled, “What if Einstein had been on Ritalin?’’

She acknowledges that her youngest boy is focusing more on his schoolwork, and that doctors say his dosages of Concerta are safe. But still, she says, she wants to stop these drugs as soon as possible. She says she does not worry if her benefits, in the future, are cut.

“God’s been good to me. If they cut me off, I’ll be all right,’’ says Fielding, who is active in parent and neighborhood groups.

As she folds laundry in her three-bedroom apartment, she says she believes her middle child, the 14-year-old, has the greatest mental disabilities. He has been diagnosed with dyslexia, and he struggles with reading. He also has asthma and emotional issues. She worries he will wind up illiterate, like her father. His SSI application has been rejected, but she is appealing.

Fielding says the SSI checks have helped get her through difficult economic times, but she has mixed feelings about the role they play among poor families. She says she decided to speak to the Globe to highlight the worrisome incentive to prescribe children drugs.

“Sometimes I don’t know why we get a check for this,’’ she said, referring to her youngest son’s case. “But if someone says you have ADHD and you’re depressed and you can get a check, they’re going to try to get a check. The poor people will take that every time. It’s all about surviving.’’

Patricia Wen can be reached at wen@globe.com.

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Tuesday, June 8, 2010

Antipsychotic [Haldol] Deflates the Brain, Drug for schizophrenia causes side effects by shrinking part of the brain.

NATURE
6 June 2010
Amy Maxmen


A leading antipsychotic drug temporarily reduces the size of a brain region that controls movement and coordination, causing distressing side effects such as shaking, drooling and restless leg syndrome.

Just two hours after injection with haloperidol, an antipsychotic commonly prescribed to treat schizophrenia, healthy volunteers experienced impaired motor abilities that coincided with diminished grey-matter volume in the striatum1 — a brain region that mediates movement.

"We've seen changes in the brain before, but to see significant remodelling of the striatum within a couple of hours is staggering," says Clare Parish at the Howard Florey Institute for brain research in Melbourne, Australia, who was not involved in the study. "Our viewpoint was that only chemical changes would happen in such a short time."

In functional magnetic resonance imaging (fMRI) scans the authors observed the participants' striatal volume diminishing and changes to the structure of the motor circuitry in their brains. Further, their reaction times slowed in a computer test taken after the treatment, indicating the onset of lapses in motor control that affect many patients on antipsychotics.
Dopamine downsizing

Haloperidol has a number of side effects, although many of these are minor and recede within weeks of starting treatment. With few better alternatives, psychiatrists have prescribed the drug for more than 40 years to treat people suffering from hallucinations, delirium, delusions and hyperactivity.

Like most antipsychotics, haloperidol blocks the D2 receptor, which is sensitive to dopamine. The drug stifles the elevated dopamine activity that is thought to underlie psychosis. D2 receptors are abundant in the striatum, where their activity regulates gene expression. But, until now, no one knew that blocking the receptors would rapidly alter the brain's physical structure.

"This is the fastest change in brain volume ever seen," says Andreas Meyer-Lindenberg, professor of psychiatry and psychotherapy at the University of Heidelberg in Mannheim, Germany, and a lead author on the report in Nature Neuroscience1. "Studies have found that the volume of brain regions changes over a number of days, but this is in one to two hours, and in half that time it bounces back."

Within a day, volunteers' brains returned to almost their original size as the effects of the single haloperidol dose subsided. Meyer-Lindenberg says this result should alleviate fears that the drug destroys brain cells. "We know it's not killing neurons because the brain rebounds," he says.

Instead, the team suggests that haloperidol downsizes synapses, the junctions through which neurons communicate. Meyer-Lindenberg speculates that the change is mediated by the protein BDNF, which is involved in synapse growth and diminishes in response to antipsychotic treatments in mice.
The bigger picture

"I think this study will cause worry to some," says Shitij Kapur, dean of the Institute of Psychiatry at King's College London. To counteract those fears, he notes that the brain changes caused by the drug seem to be reversible and that the dose used in the study was a little higher than that usually given to patients who had not taken the drug before.

The findings may also hint at why people with bipolar disorder have reduced grey matter in parts of their brains after manic mood swings2. Andrew McIntosh at the University of Edinburgh, UK, says that the connection between the brain-shrinking effects of an antipsychotic reported in this study and the grey-matter reduction he and others have observed in schizophrenic and bipolar patients is "a bit uncertain but this paper definitely makes this worthy of further investigation".

Furthermore, D2 receptors in parts of the striatum have been associated with addiction. This has led Parish to ponder on whether structural changes underlie reward-seeking behaviours. "You wonder what sort of acute changes happen through those receptors in the addicted brain because you hear of cases where addiction happens after just one exposure," she says.

*
References
1. Tost, H. et al. Nature Neurosci. doi:doi:10.1038/nn.2572 (2010).
2. Moorhead, T. et al. Biol. Psychiatry 62, 894-900 (2007). Article PubMed

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Friday, May 21, 2010

Drug Company to Pay Half a Billion Dollar Fine for ILLEGAL Marketing

Mercola.com
The World's #1 Free Natural Health Newsletter
May 20, 2010


Drugmaker AstraZeneca has agreed to pay $520 million to settle federal investigations into marketing practices for its schizophrenia drug Seroquel. This makes AstraZeneca the fourth big drug company in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs.

The company was accused of misleading doctors and patients by spotlighting favorable research while failing to adequately disclose studies showing that Seroquel increases the risk of diabetes.

The New York Times reports that:

"AstraZeneca still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug's risks. "

Sources:
New York Times April 26, 2010
The United States Department of Justice April 27, 2010


Dr. Mercola's Comments:

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The illegal and unsafe actions of drug companies make headlines yet again as AstraZeneca agrees to pay a $502 million fine to settle the federal charges of using illegal marketing tactics to drive up sales of its blockbuster drug Seroquel.

Although this sounds like a lot of money, it's little more than a symbolic slap on the wrist when you consider how much money they've made from the drug already. According to the New York Times, the antipsychotic drug Seroquel pulled in $4.9 BILLION in sales last year!

You see from the company's perspective it's merely another cost of doing business. For every dollar they are fined they are making ten. While not all of their profit was due to their illegal marketing practices, the fine was only a one-time fine, while revenues have poured in over many years and will continue to do so in the future, as a result of these illegal activities.

How Did Potent Antipsychotics Become the Top Selling Drug Category in US?

Amazingly, and something that not even I had realized until this article was being written, is that this class of antipsychotics has now surpassed cholesterol-lowering drugs as the top-selling category of drugs in the US!

This fact, in and of itself, should be a red flag that something has gone seriously awry, because no nation could possibly have that many psychotic residents.

And that's just... We don't.

Using illegal marketing tactics to promote the use of Seroquel and other drugs like it has greatly expanded the sale of these types of drugs for far less serious, and at times completely unrelated, ailments.

Making matters even worse, they've also been heavily promoted for seniors and children - groups in which this drug can be far more dangerous.

Seroquel has been found to cause rapid weight gain and diabetes, for example. And seniors with dementia are at a higher risk of death when taking this drug. These are just a couple of reasons why Seroquel has been unable to gain FDA approval for certain uses. And yet, AstraZeneca, like so many other drug companies, chose to put profits before safety and health once again.

Puny Fines after Making Massive Illegal Profits Seem to Be the Norm

Just last month I discussed the case of Pfizer, the world's largest pharmaceutical company, that was "punished" with a fine that amounted to three month's worth of profit for the illegal marketing of the painkiller Bextra.

In 2005, when Bextra was pulled from the market due to its increased risks of heart attack and stroke, about half of its $1.7 billion in profits that year were due to unapproved off-label uses.

There's no doubt that Seroquel's blockbuster status and massive sales are in large part due to dangerous off-label uses as well.

Seroquel was approved by the FDA in September 1997 for "the treatment of manifestations of psychotic disorders."

Three years, later, the FDA actually considered NARROWING its approval to the short term treatment of schizophrenia only. However, by January, 2004, the drug was approved for the short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania), and two years later, they also approved it for bipolar depression.

Schizophrenia and bipolar disorder are serious mental disorders that in many cases may warrant drug treatment, at least short term. However, AstraZeneca also pushed Seroquel for things like anger management, ADHD, Alzheimer's disease, and even difficulty sleeping!

No federal criminal charges have been filed against the company, but I wonder if that wouldn't be justified. After all, they're promoting a potent drug for diseases that they were never formally studied or approved for.Without this important proof of safety and effectiveness, they have put countless human lives at risk for serious side effects, including premature death.

How is this NOT a crime?

But wait, of course no criminal charges will be filed because, just like Wall Street bankers, these companies are "too big to fail". What a load of horse manure, pardon my language. Nevertheless, that is what happens when your profits are so large you can afford to lobby and payoff the right people in government, to effectively insulate you from any prosecution.

Yes these companies are VERY clever.

Off-Label Use of Drugs Increase Your Risk of Harmful Side Effects

While doctors can legally prescribe FDA-approved medications off-label for any use, drugmakers are not allowed to market them for anything other than approved uses.

Many physicians, however, for all intents and purposes rely nearly exclusively on drug reps to educate them about the indications for drugs and what other leading physicians are using them for, and drug companies are not shy about suggesting off-label uses.

As demonstrated by this recent rash of lawsuits, drugmakers actually go several steps further, by fraudulently manipulating doctors into prescribing their drugs for ailments that they could not gain approval for in the first place.

Complicating matters further is the fact that it can be difficult for physicians to determine what certain medications are approved for, based on the Summary of Product Characteristics (SPC) -- the information given to physicians about drugs.

In fact, according to a 2009 study, it was impossible for physicians to determine the licensing status for about 20 percent of drug... which means it's even more likely they'll rely on drug reps' opinions and suggestions.

Off-label drug use is actually extremely common, for drugs of all kinds.

According to studies conducted in Britain, when a "suitable alternative" did not exist, doctors used unlicensed or "off label" medicine in:

* 90 percent of babies in neonatal intensive care units
* 70 percent of children in pediatric intensive care units
* Two-thirds of children on general medical and surgical pediatric wards in the UK

According to two of the studies, children taking these medicines face a higher risk of side effects, with one estimate suggesting they suffer up to three times more side effects as a result.

This is why it's so important that drug companies refrain from these illegal marketing tactics, because doctors mislead by their pharmaceutical reps are literally putting their patients' lives at risk!

As Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania stated:

"People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues."

In the end that's all it is... Promoting drugs for off-label uses has nothing to do with trying to help more people. It's all about making more money off a drug that has a limited market.

The Dangerous Side Effects of Seroquel

It's hard to believe that anyone would agree to take such a potent antipsychotic unless they were suffering from a serious mental illness, but the numbers prove that plenty of people do.

This choice can be a devastating one. (And remember, it IS a choice. Your doctor cannot force you to take any drug, and in many cases, people see an ad on TV and voluntarily ask for the drug.)

The potential side effects of taking Seroquel are numerous, and some of them can be fatal.

For example, elderly patients who have lost touch with reality as a result of dementia are at an increased risk of death, which is why Seroquel is not approved for this use.

Seroquel can also increase your risk of suicidal thoughts and actions, especially in children, teens and young adults.

It's worth noting that the list of serious side effects is far longer - and these reactions are FAR MORE COMMON - than the list of the non-life threatening adverse reactions.

For example, some of the most common side effects of Seroquel include:

* High triglycerides in 23 percent of patients
* Weight gain in 23 percent of patients
* Agitation in 20 percent of patients
* High cholesterol in 17 percent of patients

Meanwhile, mild side effects like nausea, congestion and stomach pain are far less common, occurring in only two to ten percent of patients.

Be One Less Victim

Fortunately, you can avoid becoming the next victim by taking control of your health. This means educating yourself about your condition, any symptoms you may have, the drugs your doctor recommends, and other alternatives.

I can't stress this enough: You are NOT REQUIRED to take a drug recommended by your doctor.

You ARE allowed to demand detailed answers to any questions you have about the drug prescribed to you, and if you decide that the risks are greater than the potential benefit, you can "just say no," and seek out alternatives.

Remember, this is your life, and your health, so take an active role in it!. If your doctor pressures you to take it, remember that there are other doctors out there and it is probably best to find someone else who will actually LISTEN to you.

Leading a healthy lifestyle and staying educated about drug-free and non-invasive treatment options are the keys to your long-term well-being.

It's unfortunate, but many are still completely unaware of the pervasive corruption that exists within the field of pharmaceuticals. You need to understand that any corporation's primary and essential responsibility is to their shareholders -- NOT to you.

Drug companies have accumulated so much wealth, power and political influence that they're able to escape any serious consequences linking them to profiting from permanently disabling, crippling or even killing consumers. This is why it's so imperative you make your own informed decisions rather than blindly trusting the system.

Physicians must also, en masse, come to the realization that drug reps cannot be trusted. This may be one of the most difficult areas to change, as the pharmaceutical industry has devised a highly effective system of indoctrination and very specific psychological techniques to manipulate physicians.

Doctors usually believe they are immune to persuasion tactics, and drug reps know just how important it is to maintain that illusion -- which is why it works so well. However, the idea that reps provide a valuable, informative service to physicians is total fiction, created and perpetuated by the drug industry, to keep this deadly, but profitable, scheme going.

Until real change takes place, I urge you to not risk your money or your life on a paradigm designed to profit from your ill health.

Instead, take control by adopting natural lifestyle strategies that will promote your body's natural healing abilities without the need for the drug companies' latest creations.

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Monday, April 26, 2010

Why don't psychiatrists notice when patients experience medication side effects? If side effects fall in the forest, do they make a sound?

Psychology Today Blog
by Jonathan Rotenberg, Ph.D.
April 20, 2010


A rich scientific study raises more questions than it answers.

This point is exempified by new work conducted at Rhode Island Hospital and published in the Journal of Clinical Psychiatry.

The investigators followed 300 patients who were in ongoing outpatient treatment for depression over six weeks. The authors compared what the patient reported on a standardized scale of 31 different side effects (Toronto Side Effects Scale; TSES) with the information recorded by the treating psychiatrist on each patient's chart. The main finding: A stunning disconnect between psychiatrists and their patients. The average number of side effects reported by the patients on the TSES was 20 times (!) higher than the number recorded by the psychiatris. When the investigators concentrated on those side effects that were most troubling to the patient, patients still reported 2 to 3 times more side effects than were recorded by the treating psychiatrist.

The authors summarize their provocative findings in mild language, "The findings of the present study indicate that clinicians do not record in their progress notes most side effects reported on a side effects questionnaire by psychiatric outpatients receiving ongoing pharmacological treatment for depression."

Obviously all is not well in the state of Demark. Although the findings concern the treatment of depression, they raise broader questions about the doctor-patient relationship.

Why is there such a massive disconnect between what psychiatrists and patients report, on something so basic as whether prescribed medications are having untoward effects? Do psychiatrists not ask enough questions about side effects? Do psychiatrists not dig deep enough into patients' responses? Are psychiatrists hearing what patients say, but not documenting it in their notes? Or is the problem more on the patient side? Are patients reluctant to speak candidly to their doctors about side effects (i.e., yes, I am having problems with sexual functioning)? Or do patients freeze up and forget their experiences when asked in the heat of the moment (it is easier to respond to a standardized list of side effects using pencil and paper)? Or is it the situation that is to blame for this disconnect? Are patient-doctor interactions in this day and age simply too rushed to insure efficient or effective transfer of information?

Whatever the explanation, psychiatrists appear to believe that patients are having fewer problems with medications than they truly are. It is hard to see how psychiatrists can act in the best interest of their patients if they do not know what their patients are experiencing!!!!

The researchers recommend the use of a self-administered patient questionnaire in clinical practice to improve the recognition of side effects for patients in treatment. This study reveals a chasm of misunderstanding between doctors and patients. This recommendation is a sensible, but baby, step towards narrowing it...

The study:
Underrecognition of Clinically Significant Side Effects in Depressed Outpatients
Mark Zimmerman, MD; Janine N. Galione, BS; Naureen Attiullah, MD; Michael Friedman, MD; Cristina Toba, MD; Daniela A. Boerescu, MD; and Moataz Ragheb, MD
J Clin Psychiatry 2010;71(4):484–490
10.4088/JCP.08m04978blu
© Copyright 2010 Physicians Postgraduate Press, Inc.

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Thursday, October 15, 2009

$2.5M verdict over birth defects blamed on Paxil

Associated Press
By MARYCLAIRE DALE (AP)
October 14, 2009


PHILADELPHIA — A jury ordered GlaxoSmithKline to pay $2.5 million to a woman whose son was born with serious heart defects after she took the antidepressant Paxil during her pregnancy.

The closely watched verdict handed down Tuesday in Philadelphia was the first of about 600 similar cases pending across the country that blame Paxil for heart problems and other birth defects.

The jury found GlaxoSmithKline guilty of negligence but not outrageous conduct, and rejected punitive damages. The company vowed to appeal.

"The adverse events started to come in the late 1990s, early 2000. The evidence was overwhelming and alarming," said lawyer Jamie Sheller, who represented plaintiff Michelle David. "They could have known this way, way before they did, way before they changed the label in 2005."

Paxil was classified as a drug with no known link to increased birth defects from its introduction in 1992 through 2005. The Food and Drug Administration began warning in September 2005 that Paxil may be associated with birth defects and strengthened the warning four months later.

David, 28, of Bensalem delivered her full-term son, Lyam Kilker, in October 2005.

He was diagnosed with heart defects two months later and spent five months in a Philadelphia hospital, undergoing surgery to repair two holes in his heart, lawyer Jamie Sheller said Wednesday. He also has a third, separate heart defect and will need at least one more surgery as he grows, she said.

David, a dance teacher and former Philadelphia 76er cheerleader, has no history of heart defects in her family, her lawyer said.

GlaxoSmithKline argues that birth defects occur in 3 to 5 percent of all live births, whether or not the mother took medication during pregnancy.

"The scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition," the drugmaker said in a statement. "Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicine's labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

Plaintiffs lawyers will continue to pursue punitive damages in the hundreds of remaining cases, the next of which is set for trial in Philadelphia in November.

"We're starting to chip away at this story, but even as we speak, we're still fighting them, documents are still being produced, depositions are still being taken," Sheller said.

Sales of Paxil totaled $849 million last year.

Paxil has competed fiercely in the marketplace at times with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. The drug no longer has patent protection and now competes against cheaper generic versions.

Copyright © 2009 The Associated Press. All rights reserved.

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Tuesday, August 4, 2009

CCHR INTERNATIONAL Announces FDA Reported Psychiatric Drug Side Effects Search Engine

PRNEWSWIRE
August 4, 2009

Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone

Los Angeles, CA (PRWEB) August 4, 2009 -- For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).

The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.

The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.

The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).

It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.

Since the reform of the Prescription Drug User Fee Act (PDUFA) in 2007, ads for psychiatric and other drugs must include statements encouraging consumers to report adverse drug reactions to the FDA's MedWatch system--Adverse Events Reporting System (AERS). However, consumers or doctors attempting to access the AERS online were confounded by a system so complex that it was impossible to use. Although the FDA should have made the information collected readily accessible, it failed in that duty to the public. It took a computer programmer over 1,000 hours to decipher four years' worth of data to make this information available.

The programmer identified the main psychiatric drugs in the AERS, wading through quarterly reports of seven different reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication (diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each year from 2004-2006 and 2004-2008 to the FDA's MedWatch system.

Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists, other health care providers and consumers once those drugs are out in the consumer market, is fundamental to drug safety monitoring. Yet these reports have been frequently ignored or dismissed as "anecdotal" by the FDA even when serious side effects number in the thousands. The FDA approves the majority of psychiatric drugs only after Phase 2 (short term) clinical trials. However, once the drugs are out in the consumer market, the FDA is supposed to require longer clinical trials, or post-marketing studies of the drugs, however this rarely happens. Subsequently, dangerous and deadly drugs have been left without black box warnings, or on the market for far too long. The best "signal" event for the FDA to direct its resources in identifying or pulling dangerous drugs is what is happening out in the real world, with consumers and patients, not in a controlled short term clinical trial, funded by the pharmaceutical companies seeking approval for their drugs to go to market.

For years the information contained in the FDA's MedWatch reporting system has been inaccessible and therefore virtually useless for consumers and doctors. CCHR's stance has always been that consumers have the right to this information for then ̶ and only then ̶ can consumers have full "informed consent" regarding the risks of psychiatric drugs, and so it has provided this database as a free public service.

The psychiatric drug search engine features a promotional video as well as an instructional video for users on CCHR's newly launched website so they can get the information from the database they are looking for in the shortest amount of time.

About The Citizens Commission on Human Rights:

The Citizens Commission on Human Rights is a mental health watchdog co-founded in 1969 by Professor of Psychiatry Emeritus Thomas Szasz and the Church of Scientology. It is a non-profit, non political, non-religious organization that has been responsible for more than 100 reforms that help protect patients rights against abuses in the field of mental health. For more information about CCHR go to http://www.cchrint.org

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Thursday, May 28, 2009

Video-Risperdal Creating Lactating Breasts on Boys

CBS Evening News [click for graphic video]
– May 25, 2009 – Risperdal


Graphic CBS Video Covering Law Suit Against Johnson & Johnson for their Antipsychotic Risperdal Creating Lactating Breasts in Male Children


“Caution: Graphic Content:” For children “diagnosed” with ADD and bi-polar disorder, Risperdal is used for “treatment”. The side effects are putting them at serious risk.

2 Comments on Video

  • Lisa Jones RN

    I cried the first time I had to give my son Risperdal. I am now homeschooling and have him OFF the medication. He is doing well….now.

    It is the pubic school system that pushes this !! When will it ever stop?

  • It would never cross my mind to give a kid or anyone a substance to “solve” a behavioral problem.

    Why?

    Look around you – look at the ever-growing population of insane people and compare that to the ever-growing, billion-dollar drug sales business in the United States.

    People need to come to their senses and stop buying into this practice, this money-making racket, and justice needs to be brought once and for all to everyone involved in these CRIMINAL activities.

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