Psychiatr Serv. 2009 Sep;60(9):1175-81. doi: 10.1176/appi.ps.60.9.1175.
Off-label use of antipsychotic medications in the department
of Veterans Affairs health care system.
Leslie DL, Mohamed S, Rosenheck RA.
Source
Department of Public Health Sciences, Penn State College of Medicine, 600 Centerview Dr.,
Hershey, PA 17033, USA. dleslie@hes.hmc.psu.edu
Abstract
OBJECTIVE:
This study aimed to determine the prevalence of prescribing antipsychotics to
adults without schizophrenia or bipolar disorder and to identify factors associated
with such off-label use.
METHODS:
Patients with at least one prescription for an antipsychotic medication from the
Department of Veterans Affairs (VA) during fiscal year (FY) 2007 were identified in
national VA administrative databases. Rates of off-label antipsychotic use were
determined along with average doses. Multivariate logistic regression models
identified sociodemographic and clinical characteristics associated with off-label
use.
RESULTS:
Of the 279,778 individuals in FY 2007 who received an antipsychotic medication,
168,442 (60.2%) had no record of a diagnosis for which these drugs are approved.
The most common mental illness diagnoses among patients given prescriptions
for antipsychotics off label were posttraumatic stress disorder (PTSD, 41.8%),
minor depression (39.5%), major depression (23.4%), and anxiety disorder
(20.0%). Among VA patients with mental illness other than schizophrenia or
bipolar disorder, the proportion who received prescriptions for antipsychotic
medications ranged from a low of 9.1% among patients with adjustment reaction;
to about 20% for those with depression, dementia, or PTSD; and to a high of
40.7% among patients with other psychoses. Doses were low, with over half of
patients who received off-label quetiapine, risperidone, or first-generation
antipsychotics receiving doses below those recommended for schizophrenia. In
logistic regression models, patients diagnosed as having other psychosis or
dementia had the highest odds of receiving an antipsychotic medication off label.
CONCLUSIONS:
Off-label use of antipsychotic medications was common. Given that these drugs
are expensive, have potentially severe side effects, and have limited evidence
supporting their effectiveness for off-label usage, they should be used with greater
caution.
Am J Manag Care. 2012 Mar 1;18(3):e109-17.
Off-label use of antipsychotic medications in Medicaid.
Leslie DL, Rosenheck R.
Source
Penn State University College of Medicine, Public Health Sciences and Psychiatry, Hershey, PA
17033, USA. douglas.leslie@psu.edu
Abstract
OBJECTIVES:
To determine how often antipsychotics are prescribed off-label to adults without
schizophrenia or bipolar disorder who are enrolled in Medicaid, which pays for
more than 70% of antipsychotic prescriptions in the United States.
STUDY DESIGN:
Retrospective analysis of 2003 administrative data from 42 state Medicaid
programs.
METHODS:
Continuously enrolled patients with at least 1 prescription for an antipsychotic
medication were identified. For these patients, inpatient and outpatient records
were checked for any diagnosis of schizophrenia or bipolar disorder; those without
any such diagnoses were considered to have received these medications off-label.
Offlabel antipsychotic use was compared across sociodemographic groups (age,
race/ethnicity, sex). Multivariate logistic regression models identified
characteristics associated with off-label use.
RESULTS:
Of the 372,038 individuals given an antipsychotic medication, 214,113 (57.6%)
received these agents for off-label disorders. Off-label use among patients
receiving an antipsychotic was more prevalent among individuals under age 21
years (75.9%) and those 65 years and older (64.8%) than it was among those
aged 21 to 64 years (49.0%). Rates of off-label use were relatively high for
Hispanics (65.7%) and low for African Americans (52.3%) compared with whites
(58.2%). Off-label use was most common among patients receiving risperidone
and least common among patients receiving clozapine.
CONCLUSIONS:
Off-label use of antipsychotic medications is common, particularly among the
elderly and children/adolescents. Given that these drugs are expensive, have
potentially severe side effects, and have limited evidence supporting their
effectiveness off-label, they should perhaps be used with greater caution.
P HAR MA & H EA LT HC AR E | 11/11/2012 @ 7:59PM |2,558 views
Nine Italian Cardiologists Arrested In Broad Investigation Of Research
Fraud And Misconduct
BMJ. 2012 Jan 3;344:d7292. doi: 10.1136/bmj.d7292.
Publication of NIH funded trials registered in
ClinicalTrials.gov: cross sectional analysis.
Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM.
Source
Section of General Internal Medicine, Department of Medicine, Yale University School of
Medicine, New Haven, CT 0520, USA. joseph.ross@yale.edu
Abstract
OBJECTIVE:
To review patterns of publication of clinical trials funded by US National Institutes
of Health (NIH) in peer reviewed biomedical journals indexed by Medline.
DESIGN:
Cross sectional analysis.
SETTING:
Clinical trials funded by NIH and registered within ClinicalTrials.gov
(clinicaltrials.gov), a trial registry and results database maintained by the US
National Library of Medicine, after 30 September 2005 and updated as having
been completed by 31 December 2008, allowing at least 30 months for publication
after completion of the trial.
MAIN OUTCOME MEASURES:
Publication and time to publication in the biomedical literature, as determined
through Medline searches, the last of which was performed in June 2011.
RESULTS:
Among 635 clinical trials completed by 31 December 2008, 294 (46%) were
published in a peer reviewed biomedical journal, indexed by Medline, within 30
months of trial completion. The median period of follow-up after trial completion
was 51 months (25th-75th centiles 40-68 months), and 432 (68%) were published
overall. Among published trials, the median time to publication was 23 months (1436 months). Trials completed in either 2007 or 2008 were more likely to be
published within 30 months of study completion compared with trials completed
before 2007 (54% (196/366) v 36% (98/269); P<0.001).
CONCLUSIONS:
Despite recent improvement in timely publication, fewer than half of trials funded
by NIH are published in a peer reviewed biomedical journal indexed by Medline
within 30 months of trial completion. Moreover, after a median of 51 months after
trial completion, a third of trials remained unpublished.
Are Pharma Companies Using Foreign Research
Studies to Boost Off-label Sales?
by A DM IN on A UG UST 2, 2 0 11
In this era of mega international pharmaceutical mergers, pending False Claims
Act lawsuits oftentimes bubble to the surface at the closing table. Recently, as
Teva Pharmaceuticals looked to wrap up its acquisition of Cephalon, Inc., it was
revealed that the United States government was, once again, examining
Cephalon’s marketing practices. Specifically, Cephalon disclosed that it had
recently received a government subpoena requesting documents related to the
alleged off-label promotions of its Treanda medication. While Trenda is only FDA
approved for the treatment of chronic lymphocytic leukemia, allegations are
swirling that Cephalon pushed the medication as a suitable first-line treatment of
non-hodgkin’s lymphoma.
According to one news source, government investigators are especially interested
in “uncompleted clinical studies that may be used to support off-label use,” and, in
particular, “documents pertaining to a clinical study being conducted by to Mathias
Rummel, who is the head of hematology at the University Hospital in Giessen,
Germany.” This comes on the heels of recent announcements that the U.S. Justice
Department is looking to expand its investigations into overseas pharmaceutical
research studies, in order to uncover clinical trial fraud.
“Oftentimes enticed by lowered regulatory hurdles, pharmaceutical companies are
increasingly flocking to foreign researchers to study the unapproved uses of their
products,” said Nolan & Auerbach partner and former Taxpayers Against Fraud
president Jeb White. “When beneficial preliminary data emerges from these
studies, the results seep their way into paid speaker presentations and the
promotional arsenals of pharmaceutical sales representatives. The end result is
that off-label data is promoted to health care providers, outside the watchful eye of
the U.S. Food & Drug Administration.”
Only time will tell if Cephalon was engaged in this international end run around the
FDA. However, the message should be clear to the pharmaceutical industry that
illegal off-label promotions, wherever their origin, will not be tolerated in the United
States. Nolan & Auerbach, P.A. partner Ken Nolan wrote about Pharmaceutical
Research Subcontractors in the October 2003 issue of Contract Pharma.
J&J Fined $70 Million for International Kickbacks
by NO LA N AN D AU E R B AC H on MAY 1 9, 2 011
Pharmaceutical giant Johnson and Johnson has agreed to pay $48.6 million in
disgorgement charges, and another $21.4 million in criminal charges as part of a
settlement agreement. These fines are in response to allegations brought forward
by the Securities and Exchange Commission contending J&J paid out kickbacks to
foreign doctors, hospitals, and governments to gain drug prescriptions, use of
medical equipment, and even government contracts.
Some of the kickbacks were not in the form of direct cash, but rather indirectly
paid, such as inappropriate travel with lavish dinners and gifts, and the use of fake
civil contracts, slush funds, and off-shore companies.
The methods used to break the law are great and will always vary. When the
bottom line takes greater precedence than the care of the patient, companies will
always seek a way to circumvent the system. Nolan & Auerbach, P.A. encourages
individuals that may have witnessed fraud, and have evidence of this fraud to step
forward. The actions of these brave individuals keep our healthcare system safe
and honest.
How Independent Are Vaccine Defenders?
2008-0725, CBS News
http://www.cbsnews.com/stories/2008/07/25/cbsnews_investigates/main4296175.
shtml
They're some of the most trusted voices in the defense of vaccine safety: the
American Academy of Pediatrics, Every Child By Two, and pediatrician Dr. Paul
Offit. But CBS News has found these three have something more in common strong financial ties to the industry whose products they promote and defend. The
vaccine industry gives millions to the Academy of Pediatrics for conferences,
grants, medical education classes and even helped build their headquarters. The
totals are kept secret, but public documents reveal bits and pieces. A $342,000
payment from Wyeth, maker of the pneumococcal vaccine - which makes $2
billion a year in sales. A $433,000 contribution from Merck, the same year the
academy endorsed Merck's HPV vaccine - which made $1.5 billion a year in sales.
Every Child By Two, a group that promotes early immunization for all children,
admits the group takes money from the vaccine industry, too - but wouldn't tell us
how much. Then there's Paul Offit, perhaps the most widely-quoted defender
of vaccine safety. He's gone so far as to say babies can tolerate "10,000
vaccines at once." In fact, he's a vaccine industry insider. Offit holds in a
$1.5 million dollar research chair at Children's Hospital, funded by Merck. He
holds the patent on an anti-diarrhea vaccine he developed with Merck. And
future royalties for the vaccine were just sold for $182 million cash.
Note: For an excellent report endorsed by dozens of respected doctors and
nurses on the serious risks and dangers of vaccines, click here. For powerful
evidence presented in major media articles that some vaccines are much more
dangerous than the health industry will acknowledge, click here.
Report: About 30 cents of every health care dollar
wasted; US can cut costs without rationing
2012-09-
06, Washington Post/Associated Press
http://www.washingtonpost.com/politics/report-about-30-cents-of-every-health-...
The U.S. health care system squanders $750 billion a year — roughly 30 cents of
every medical dollar — through unneeded care, byzantine paperwork, fraud and
other waste, the influential Institute of Medicine [said] in a report. President Barack
Obama and Republican Mitt Romney are accusing each other of trying to slash
Medicare and put seniors at risk. But the counter-intuitive finding from the report is
that deep cuts are possible without rationing, and a leaner system may even
produce better quality. More than 18 months in the making, the report identified
six major areas of waste: unnecessary services ($210 billion annually);
inefficient delivery of care ($130 billion); excess administrative costs ($190
billion); inflated prices ($105 billion); prevention failures ($55 billion), and
fraud ($75 billion). Adjusting for some overlap among the categories, the
panel settled on an estimate of $750 billion. The report makes ten
recommendations, including payment reforms to reward quality results instead of
reimbursing for each procedure, improving coordination among different kinds of
service providers, leveraging technology to reinforce sound clinical decisions and
educating patients to become more savvy consumers. The report’s main message
for government is to accelerate payment reforms, said panel chair Dr. Mark Smith,
president of the California HealthCare Foundation, a research group. For
employers, it’s to move beyond cost shifts to workers and start demanding
accountability from hospitals and major medical groups. For doctors, it means
getting beyond the bubble of solo practice and collaborating with peers and other
clinicians.
Note: The US spends far more on health care than most other developed
countries which provide health care to all of their citizens. The US system is driven
by profits.
Antidepressant Pills May Help Only Most Severe
Cases
2010-01-06,
http://www.bloomberg.com/apps/news?pid=20601124&sid=aIjvgTRz2PN8
Antidepressants ... may be no better than dummy pills for people with mild or
moderate depression, according to a study that suggests 70 percent of patients
wouldn’t benefit from the drugs. In a review of six trials of antidepressants
involving more than 700 patients published yesterday in the Journal of the
American Medical Association, researchers led by Jay Fournier at the University of
Pennsylvania found the drugs helped only those patients with the most severe
depression. Doctors, policy makers and sufferers should be made aware that
there’s little evidence to show the treatments will benefit patients with less severe
symptoms, the authors said. “This important feature of the evidence base is not
reflected in the implicit messages present in the marketing of these medications to
clinicians and the public,” they said. The researchers combined data from six trials.
The drugs had a “nonexistent to negligible” effect on patients with mild,
moderate and severe symptoms, compared with those who took a placebo,
according to a commonly used scale used to measure the disorder. The pills
had a large effect on patients with very severe symptoms, the study found.
The danger of drugs … and data
2009-05-09, The
Guardian (One of the UK's leading newspapers)
http://www.guardian.co.uk/commentisfree/2009/may/09/bad-science-medicaljourn...
A fascinating court case in Australia has been playing out around some people
who had heart attacks after taking the Merck drug, Vioxx. This medication turned
out to increase the risk of heart attacks in people taking it, although that finding
was arguably buried in their research, and Merck has paid out more than £2bn to
44,000 people in America. The first ... thing to emerge in the Australian case is
email documentation showing staff at Merck made a "hit list" of doctors who
were critical of the company, or of the drug. This list contained words such
as "neutralise", "neutralised" and "discredit" next to the names of various
doctors. "We may need to seek them out and destroy them where they live,"
said one email, from a Merck employee. Staff are also alleged to have used
other tactics, such as trying to interfere with academic appointments, and dropping
hints about how funding to institutions might dry up. Worse still, is the revelation
that Merck paid the publisher Elsevier to produce a publication. This time Elsevier
Australia went the whole hog, giving Merck an entire publication which resembled
an academic journal, although in fact it only contained reprinted articles, or
summaries, of other articles.