NYT series digs into overprescription and developmentally disabled adults
Filed under: Health journalism, Health policy, Hot Health Headline, Pharmaceuticals, Public health, Public records
In the series Abused and Used, New York Times reporter Danny Hakim and a host of his colleagues have been investigating how public resources are used to treat developmentally disabled New Yorkers. The series is ongoing, but hit an inflection point with the publication of Hakim’s piece on the few-strings-attached use of very powerful drugs to treat some of the state’s most vulnerable adult residents.
Developmental disabilities, Hakim writes, often manifest themselves in ways that are easily mistaken for mental illness, and these misdiagnoses can lead to unnecessary or improper medication. “In fact,” Hakim writes, “developmentally disabled residents of group homes in New York are more likely to be given Ativan, an anti-anxiety drug that has a tranquilizing effect, than multivitamins, the records show.”
Hakim’s reporting is rich with both anecdotes and data. These paragraphs from the series will give you an idea of how he approached the issue.
Tens of thousands of powerful pills created to treat serious mental illnesses like schizophrenia are given to developmentally disabled people in the care of New York State every day.
…a review by The Times of previously unreleased records, as well as interviews with state employees, clinicians, family members and outside experts, reveals that the psychotropic medications, which alter the brain’s chemistry, are often dispensed sloppily, without rigorous or regular review, by general practitioners with little expertise in the area.
And low-level workers at state group homes are frequently given discretion to increase the medication “as needed,” despite their lack of significant training.
Psychologists who have worked inside the system describe a culture in which the drugs are used to control the disruptive behavior of the developmentally disabled — people with conditions like autism, Down syndrome and cerebral palsy — an approach increasingly discredited in the field.
Antipsychotic use booms among Canadian kids
Filed under: Children, Hot Health Headline, Pharmaceuticals
Writing for The Vancouver Sun and Postmedia News, Sharon Kirkey and Pamela Fayerman, report that, in an environment where the rate at which physicians are recommending certain antipsychotics for children has doubled since 2006, a local children’s hospital has launched what the reporters call “the world’s first clinic to help children cope with the side effects of such medications.”
The clinic, which helps children and their parents prepare for antipsychotic use or cope with its side effects, opened in April and has a four-week waiting list.
(Dr. Jana Davidson, a child and adolescent psychiatrist who helped establish the specialized clinic) said she helped create the clinic because of her increasing alarm over the side effects of treatment in her patients. While she believes the medications are sometimes prescribed inappropriately, they are often useful for a range of disorders including severe aggression, mania in bipolar disorder and schizophrenia. But the side effects can be serious.
“I would see kids with psychosis in the emergency department and then I would see them again 10 months later and they would be 30 to 50 pounds heavier,” she said.
Despite sometimes serious neurological side effects, more Canadian families are turning to the drugs and antipsychotic drug recommendations for youth jumped 114 percent in Canada from 2005 to 2009.
The drugs — which have not been approved in Canada for use in children under 18 — are being used for attention-deficit/hyperactivity disorder, conduct disorders, irritability related to autism, mood disorders, physical or verbal aggression and other behavioural problems.
Fla. juvenile justice system relies on heavy antipsychotic use
Filed under: Children, Conflicts of interest, Health journalism, Hot Health Headline
In looking into the state Department of Juvenile Justice’s use of powerful prescription antipsychotics, The Palm Beach Post’s Michael LaForgia “analyzed department drug purchasing information and state Medicaid billing data and reviewed thousands of pages of DJJ inspection reports, drug company disclosure records and court documents.” It shows, as he surfaces with some powerful numbers and equally alarming anecdotes (Part 1, Part 2, Infographic).
…in state-run jails and residential programs, antipsychotics were among the top drugs bought for kids - and they routinely were doled out for reasons that never were approved by federal regulators, a Palm Beach Post investigation has found.
A key concern is that the prescriptions may be driven by their improper use as chemical restraints, or by the hefty speaker (and related) fees being paid from pharmaceutical companies to the most prolific prescription writers. Unfortunately, specifics are hard to come by as most homes are run by private contractors and the state doesn’t have the resources for close monitoring. For this story, the reporters were only able to obtain two years worth of data for 25 jails and three programs – a fraction of the statewide total. Those data still paint what LaForgia calls a “startling story.”
A look at the sheer numbers of drugs purchased … suggests a startling story is unfolding in state homes for wayward kids.
In 2007, for example, DJJ bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children.
That’s enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day.
More antipsychotics prescribed to foster children
Filed under: Children, Government, Health policy, Hot Health Headline, Pharmaceuticals
Need To Know, the PBS newsmagazine, recently took a look at the use of antipsychotics in foster children. Shoshana Guy’s piece opens with an anecdote about one 10-year-old foster child (now adopted) in Texas and expands from there. In nine years as a ward of the state, the boy was prescribed 20 different drugs by nine different doctors. After his adoption, a new, private physician diagnosed him only with ADHD, treatable with a single medication.
Antipsychotics are designed primarily to treat bipolar disorder and schizophrenia, diseases which affect about 3 percent of the population. Yet somehow, they’re the top selling class of drugs in the United States with $14.6 billion in sales in 2009.
Specific numbers on foster children are hard to come by, but the 2010 paper cited in the broadcast, Antipsychotic Medication use in Medicaid Children and Adolescents (48-page PDF), is a good start. Broader forces, such as pharmaceutical marketing and the increasing frequency of mental illness diagnoses for children are at work here, Guy found, but that doesn’t mean that the foster care environment itself isn’t also a factor. It’s a system in which people are frequently looking for ways to “manage” problematic children. Judging by a companion post on Need to Know, this sounds like a story that will develop significantly in the coming year.
…foster care children are prescribed drugs at a rate much greater than that of other kids. Concern over their well-being — not to mention the amount it costs to treat them — has prompted the Government Accountability Office to investigate potentially abusive prescribing practices in America’s state foster care systems. The GAO findings are expected to come out later this year.
Watch the full episode. See more Need To Know.
You can find Need to Know’s health stories on this landing page, but as of yet I haven’t been able to find a health-specific RSS feed.
Some fear DSM update opens door for exploitation
On All Things Considered, NPR’s Alix Spiegel looks to the past and future to ferret out the potential drawbacks and benefits of the expanded psychiatric diagnoses proposed in the upcoming revision of the American Psychiatric Association’s Diagnostic and Statistical Manual.
Photo by Richard Masoner via Flickr
Spiegel begins with the forceful perspective of Allen Frances, the man who edited the last update of the DSM. From Frances, Spiegel pulls a few cautionary tales of the unintended consequences of changing DSM entries.
The first? Aspergers.
It’s a disease that needed to be diagnosed, Frances says, but it’s now massively overused because of the unforeseen “unintentional incentive” created by schools that offer greatly expanded educational resources to children diagnosed with Aspergers.
“And so kids who previously might have been considered on the boundary, eccentric, socially shy, but bright and doing well in school would mainstream [into] regular classes,” Frances says. “Now if they get the diagnosis of Asperger’s disorder, [they] get into a special program where they may get $50,000 a year worth of educational services.”
Another cautionary tale? Bipolar disorder. The last DSM revision made it a far easier diagnosis to get. In essence, this easier diagnosis opened a gaping door in medicine, one which pharmaceutical companies quickly muscled through.
“Drug companies got indications for treating bipolar disorder,” Frances says. “Not just with mood stabilizers, but also with the newer antipsychotic drugs. And they began very intensive ubiquitous advertising campaigns. So the rates of bipolar disorder doubled. And lots of people got way too much antipsychotic and mood stabilizing medicines. And these aren’t safe drugs.”
For the other side of the story, Spiegel spoke to a psychiatrist who argued that broadening diagnoses means that fewer of the mentally illl go undiagnosed, and that diagnoses are delivered earlier than they would be otherwise. Furthermore, he believes that adding illnesses to the DSM will spark research and investment toward treating those ilnesses.
Ethics professor takes on clinical trials, marketing
Filed under: Hot Health Headline, Pharmaceuticals
Writing for Mother Jones, University of Minnesota medical ethics professor Carl Elliott digs into the Dan Markingson story first covered by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto. Elliott works at the same institution as the physicians who who administered a Seroquel trial that the 26-year-old was enrolled in when he committed suicide.
Given his teaching field and institution, it’s not surprising that Elliot couldn’t stay away from the Markingson story.
…the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.
Elliot goes after the idea that the new wave of anti-psychotics was any safer than its predecessors, then explains the clinical trial manipulations he says were used to claim they were.
From there, Elliot takes on the use of clinical trials for marketing purposes. Clinical trials can be dangerous, which is theoretically acceptable if they have the potential to advance medical care. But what if patients are just being exposed to those dangers in an effort to sell more drugs?
Medicaid kids more likely to get antipsychotics
Filed under: Hot Health Headline, Pharmaceuticals
New York Times reporter Duff Wilson reports on federally funded research that has revealed that children covered by Medicaid are four times more likely to get antipsychotic drugs than those covered by private insurers. Wilson puts the story in context with discussion of possible new FDA regulations on antipsychotics for children, as well as state efforts to curb the Medicaid-related prescriptions.
A group of Medicaid medical directors from 16 states, under a project they call Too Many, Too Much, Too Young, has been experimenting with ways to reduce prescriptions of antipsychotic drugs among Medicaid children. They plan to publish a report early next year.
Wilson explores a number of potential causes for the disparity, noting that, at the very least, children on Medicaid don’t get adequate mental health services.
600-plus Ill. patients drugged without consent
After a review of 40,000+ inspection reports for Illinois nursing homes, the Chicago Tribune’s Sam Roe reports that the paper found 1,200 violations (affecting 2,900 patients) involving psychotropic drugs since 2001. More than 600 patients were drugged without their consent. According to Roe, “The actual numbers are likely far higher because regulators inspect some facilities just once every 15 months, and even then they usually check only a small sample of residents for harm.”
The violations, many of which were caused by a desire to make patients easier to deal with, were “for ‘chemical restraint’ and ‘unnecessary drugs’ as well as cases involving dosages that exceeded safety standards or falls in which psychotropics possibly played a role.”
While some nursing home residents suffer from major mental illnesses, such as schizophrenia, the inspection reports show that many patients harmed by antipsychotic drugs had not been diagnosed with psychosis. They were disabled by Alzheimer’s disease, cancer or Parkinson’s disease. Some were blind or so frail that they could not breathe without the aid of an oxygen tank.
In a follow-up story, Roe reveals that doctors responsible for these dubious prescriptions are not held accountable, even when cited by government entities.
The Chicago Tribune’s full series on nursing home safety can be found here.
Recent workshop
AHCJ’s Aging in the 21st Century workshop, held Oct. 16 and 17 in Miami, addressed many topics raised by the Tribune’s reports, as well as the changing picture of aging Americans and key research and issues related to this growing population. Tip sheets and presentations from that workshop are available to AHCJ members.
Related tip sheets
Aging Nation: Troublesome Health Care Issues
Headlines an advocate for seniors would like to see
The impact of aging upon health care
Covering nursing homes and other issues of aging
How will retiring boomers affect the national health agenda?
You Can Run, but You Can’t Hide: Policy and Problems in Long-Term Care
Biology of Aging: Sources and Resources
Sealed Seroquel documents hearing is Thursday
A closely watched hearing will take place in a federal courtroom in Orlando, Fla., tomorrow [Thursday] over the extent to which AstraZeneca should be forced to divulge internal documents filed in connection with product-liability litigation over its Seroquel antipsychotic. About 6,000 lawsuits have been consolidated and allege the drugmaker failed to adequately disclose that the pill can cause serious weight gain and diabetes.
At issue is whether thousands of pages of material should be unsealed. Typically, numerous documents are sealed at the outset of such litigation under agreements between attorneys for defendants and plaintiffs, in part, to speed along the proceedings. Companies also seek to have documents sealed to avoid publicity, investigations and additional lawsuits.
But earlier this month, Bloomberg News filed a motion to have some of the Seroquel documents unsealed, citing ”the public’s right of access to judicial documents.” An AstraZeneca spokesman told BusinessWeek that releasing incomplete information could create a public health risk. However, Bloomberg argued that concerns about health risks are among the very reasons the documents should be unsealed.
Not surprisingly, the controversy is drawing parallels to the litigation over Eli Lilly’s Zyprexa, another antipsychotic linked to serious weight gain and diabetes. However, the Zyprexa lawsuits yielded an unexpected ruckus when David Egilman, a Brown University professor and an expert witness for the plaintiffs, leaked sealed Lilly documents to the media (background here).
Meanwhile, the Seroquel case is generating interest for yet another reason - allegations of sexual impropriety. An AstraZeneca employee, who was responsible for the drug in the United States, allegedly cavorted with a Seroquel researcher in the United Kingdom and a ghostwriter in the United States, according to court documents. You can read more about that here.
Update: AstraZeneca lawyer Stephen McConnell announced at the hear that AstraZeneca would release the documents, according to AmericanLawyer.com.
14 meds used off label need further study
Researchers have assembled a list of 14 widely prescribed drugs they believe urgently need additional study to determine safety and effectiveness for off-label use. Their list, which specifically targets meds that are widely used off-label without proper scientific backing, include a number of popular antidepressants and antipsychotics. And the most common off-label use for six of the drugs was for bipolar disorder.
“Off-label prescribing means that we’re venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective,” Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center, who is the senior author of the study, says in a statement. “This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence.”
At the top of the list was AstraZeneca’s Seroquel antipsychotic, which was approved by the FDA to treat schizophrenia. Not only did this drug lead all others in its high rate of off-label uses with limited evidence (76 percent of all uses of the drug), the researchers say it raised additional concerns because of its high cost at $207 per prescription, heavy marketing and the presence of a “black-box” warning from the FDA.
The study, which appears in Pharmacotherapy, appears only days after an FDA advisory committee criticized the growing off-label use of antipsychotics in children and amid an investigation by a group of state Medicaid directors. The consortium is evaluating the use of the drugs in children on state Medicaid rolls to ensure they are properly prescribed. The growing use of the medicines has been driven partly by the sudden popularity of the diagnosis of pediatric bipolar disorder.
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New at HealthJournalism.org
- Data gives depth to investigation of patient safety
- What reporters should know about Alzheimer’s and related dementias
- Apply for fellowships to attend Health Journalism 2012
- AHCJ asks Supreme Court to permit broadcast of arguments in health reform case
- Tips for print, online journalists to embrace broadcast opportunities
- Numbers reveal how often, or how rarely, states check doctors’ disciplinary records
- How I did it: Falsified charts in nursing homes linked to patient care
- Access Denied: Looking at a lack of health care availability
- Transparency & medical errors: Public reporting of patient harm is a potent force
