NPR. "We're not talking about abandoning standards for safety and efficacy, we're talking about leveraging opportunities in science so we can do a more effective job as regulators and also improve the drug development process." The agency said eliminating or reducing the number of routine visits to the doctor could free up prescribers "to spend time with more seriously ill patients, reduce the burdens on the already over burned health care system and reduce health care costs." Drugmakers would have to request a switch for each drug individually, and the FDA would judge the safety of each proposal on a case-by-case basis. "We're not talking about very specific drugs right now, we're talking about the concept," Dr. Janet Woodcock, director of FDA's drug center, told NPR. --- On the Net:
1Turning Point Alcohol and Drug Centre, Eastern Health and Monash University, Victoria, Australia
2Ambulance Victoria, Victoria, Australia
- Belinda Lloyd, Turning Point Alcohol and Drug Centre, 54?62 Gertrude Street, Fitzroy, VIC 3065, Australia. Email:
belindal@turningpoint.org.au
To the Editor
In the December 2010 issue,
Hollingworth
et al
. (2010 detailed increased prescribing of atypical antipsychotic medications in Australia between 2002 and 2007. While olanzapine and risperidone remain the most commonly prescribed atypical antipsychotics, quetiapine prescribing is increasing, with PBS prescriptions rising by 27% between 2008/09 (431,096 and 2009/10 (545,410 (
Department of Health and Ageing, 2010 . Reasons for the growing use (including off-label prescribing relate to its sedative properties and favourable extrapyramidal and metabolic profile, as well as emerging evidence of positive outcomes at low doses for a range of mental disorders (
Hollingworth et al., 2010 .
While the toxicity profile of atypical antipsychotics is considered preferable to typical agents, particularly regarding overdose risk, recent literature has called the relative safety of quetiapine into question. In one study, quetiapine-related overdoses were more likely to result in hypotension, respiratory depression, coma, or death than all the other antipsychotics combined (
Ngo et al., 2008 . This is particularly concerning given the growing number of case reports citing quetiapine as a potential substance of misuse, a phenomenon unseen with other atypical antipsychotic preparations (
Sansone and Sansone, 2010 .
A recent study (
Lloyd and McElwee, 2011 identified a non-significant increase in antipsychotic-related ambulance attendances over 2000?2009 in metropolitan Melbourne. While demographic characteristics remained relatively consistent over the period, there was a significant increase in antipsychotic-related attendances where other drugs (both licit and illicit were also implicated in presentations. However, differential harms across different antipsychotic preparations have not been adequately explored at a community level.
To further our understanding of this emerging issue, we analysed ambulance attendance data from metropolitan Melbourne across different antipsychotic preparations to provide a preliminary quantification of quetiapine-related harms. Data were derived from the Ambo Project database (
Lloyd and McElwee, 2011 , utilizing data from patient care records completed by paramedics, with additional coding undertaken to identify involvement of alcohol or other drugs in ambulance presentations. While there was a small increase in antipsychotic-related ambulance attendances between 2000/01 and 2009/10 (from 783 to 1074 attendances , quetiapine-related attendances increased substantially over the same period (from 32 in 2000/01 to 598 in 2009/10 . Similar increases were not found for other antipsychotic preparations.
Anecdotal reports from Victorian alcohol and drug agencies participating in the Earlier Identification of Drug Harms Project (unpublished data indicate that quetiapine demand, use, diversion, misuse, and harms are ongoing issues, particularly for clients with a history of illicit drug use. Over the course of this project involving bi-monthly data collection, quetiapine was the only antipsychotic consistently reported as being used in a problematic manner, regardless of source of supply.
Such an increase in acute quetiapine-related harm represents a growing public health issue. Further exploration is required to identify the nature and magnitude of quetiapine-related harms, population groups at increased risk of harm, prescribing trends, and strategies to ensure benefits of quetiapine are balanced against potential risks to patients, and costs to the community. In the meantime, it is important that clinicians are aware of growing misuse and diversion of quetiapine, and adopt prescribing practices that minimize the risk of harms.
Funding
This project is a collaborative project between Turning Point Alcohol and Drug Centre and Ambulance Victoria, and is funded by the Victorian Department of Health.
Acknowledgments
The authors would like to acknowledge and kindly thank Ambulance Victoria and its paramedics for their entry of data used in this study and Annie Haines for coding cases.
- © The Royal Australian and New Zealand College of Psychiatrists 2012
The telephone survey, which was funded by New York State’s Office of Alcoholism and Substance Abuse Services (OASAS and conducted in conjunction with the Partnership at Drugfree.org, included responses from more than 2,500 people over 18, who were asked, “Did you used to have a problem with drugs or alcohol but no longer do?”
Read more:
http://healthland.time.com/2012/03/07/quitting-drugs-or-alcohol-10-of-the-u-s...
Telegraph. The supervisors of one trial noted, “It was rather common for patients to claim significant insights into their problems, to feel that they had been given a new lease on life, and to make a strong resolution to discontinue their drinking.” In the 70s, governments began crackdowns on any aspect of LSD being clinically studied and research was left incomplete and shelved. None of the experiments that were begun featured enough patients to draw any firm conclusions, however a reanalysis of all the data taken together suggests the compound could have potential after all. A study, presented in the Journal of Psychopharmacology, looked at data from six trials with 536 patients and it said there was a “significant beneficial effect” on alcohol abuse, which lasted several months after as little as one dose was taken. LSD is one of the most powerful hallucinogens ever identified. It appears to work by blocking serotonin in the brain, which controls functions including perception, behavior, hunger and mood, reports
BBC News. For the group of patients taking LSD, 59 percent showed reduced levels of alcohol misuse compared with 38 percent in the other group. This effect was maintained for up to six months after taking the hallucinogen, but it disappeared after a year. The report’s authors, Teri Krebs and Pal-Orjan Johansen, told BBC News: “A single dose of LSD has a significant beneficial effect on alcohol misuse,” and suggested that more regular doses might lead to a sustained benefit. Norwegian researcher and fellow of Harvard Medical School, who led the research, Pal-Orjan Johansen said in a recent press statement: “Given the evidence for a beneficial effect of LSD on alcoholism, it is puzzling why this treatment approach has been largely overlooked.” Dr. David Nutt, former advisor on drugs to the government, told The Telegraph: “I think this study is very interesting and it is a shame the last of these studies were done in the 1960s.” “I think these drugs might help people switch out of a mindset which is locked into addiction or depression and be a way of helping the brain switch back to where it should be, in a similar way that Alcoholics Anonymous programs do.” For the moment, studying human behavioral responses rather than brain chemistry may be more helpful in understanding how the drugs work, writes Arran Frood for
Nature. Robin Carhart-Harris, a psychopharmacologist at Imperial College London who has researched how psilocybin could treat depression, told Frood that psychedelics must work at both biological and psychological levels. “Psychedelics probably work in addiction by making the brain function more chaotically for a period — a bit like shaking up a snow globe — weakening reinforced brain connections and dynamics,” he said. --- On the Net:
Mar 8
Video-
The Importance of the New Hepatitis C Treatments in Clinical Practice
Updates at
NATAP
CROI:
GS-7977 + Ribavirin in HCV Genotype 1 Null Responders: Results from the ELECTRON Trial -
CROI:
The Pharmacokinetic Interactions of HCV Protease Inhibitor TMC435 with Rilpivirine, Tenofovir, Efavirenz or Raltegravir in Healthy Volunteers
CROI:
Evaluation of NS3 Amino Acid Variants in a Phase 1b Study of GT 1 Infection with the HCV Protease Inhibitor, MK-5172
Pioglitazone Decreases Hepatitis C Viral Load in Overweight, Treatment Naïve, Genotype 4 Infected-Patients: A Pilot Study
Insulin resistance (IR is induced by chronic hepatitis C virus (HCV genotypes 1 and 4 infections. It is not known whether drugs that affect IR such as Pioglitazone and Prednisone also affect serum HCV RNA titers independently of PEG-Interferon-a2/ribavirin treatment. The primary aim was to assess whether Pioglitazone by improving IR and/or inflammation decreases HCV viral load independently of standard of care HCV treatment. A secondary aim was to assess whether Prednisone, a drug that induces insulin resistance and stimulates HCV viral entry and replication in replicon culture systems, increases HCV viral load in this population......
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An experimental vaccine from GlaxoSmithKline halved the risk of African children getting malaria in a major clinical trial, making it likely to become the world’s first shot against the deadly disease.
Final-stage trial data released on Tuesday showed it gave protection against clinical and severe malaria in five- to 17-month-olds in Africa, where the mosquito-borne disease kills hundreds of thousands of children a year.
“These data bring us to the cusp of having the world’s first malaria vaccine,” said Andrew Witty, chief executive of the British drugmaker that developed the vaccine along with the nonprofit PATH Malaria Vaccine Initiative (MVI .
While hailing an unprecedented achievement, Witty, malaria scientists and global health experts stressed that the vaccine, known as RTS,S or Mosquirix, was no quick fix for eradicating malaria. The new shot is less effective against the disease than other vaccines are against common infections such as polio and measles.
“We would have wished that we could wipe it out, but I think this is going to contribute to the control of malaria rather than wiping it out,” Tsiri Agbenyega, a principal investigator in the RTS,S trials in Ghana, told Reuters at a Seattle, Washington, conference about the disease.
U.S. authorities are looking at pharmacy companies with possible Canadian connections as they seek the source of fake cancer drugs entering their country.
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