European Parliament legislation will improve the regulation of pediatric drug treatment, according to an Editorial in the British Medical Journal (BMJ), this week's issue.
Author, Professor Imti Choonara, University of Nottingham, UK, explains that over the past decade studies have indicated that the use of unlicensed and off-label drugs to treat children is widespread. Eight years ago the European Union had expressed concern about the popularity of off-label drugs usage for children, rather than treatments which had been scientifically evaluated and licensed. In December last year the European parliament introduced legislation to make sure that drugs used for pediatric treatment are subject to high quality research.
It will also provide improved data on the advantages and disadvantages of medications used for babies and children, without subjecting children to needless clinical trials and without undermining the introduction of new drugs for adults.
The legislation encourages companies to study drugs for children, with some financial incentives. However, the author notes that in America drug companies tend to study drugs that have done well with adults - the ones that have made the most money - possibly at the expense of the clinical needs of infants and children.
A register of European clinical trials of pediatric drugs will be established, and the results which are sent to the regulatory agency will be available to the public. The writer stresses that transparency is crucial if it is to benefit European children. It will be necessary that the pharmaceutical industry work closely with pediatric health professionals to make sure that all clinical trials in children are designed and performed safely.
The new legislation will hopefully stimulate scientific interest in the study of pediatric drugs and raise the total number of pediatric clinical pharmacologists in the European Union, the writer concludes.
http://www.medicalnewstoday.com/articles/91876.php
Friday, December 14, 2007
Monday, December 11, 2006
Dissolving Heart Stent Created
Imagine a heart stent which completely dissolves after a while, minimizing the risk of side-effects, such as secondary blood clots, while at the same time making it easier to perform further surgery on the affected artery. Such a stent has been developed at Auckland City Hospital, New Zealand.
A heart stent is a type of scaffold, or mesh, which is placed in a blocked/narrowed artery to keep it open. Stents are commonly used for heart attack patients, people with a clogged artery, as well as patients with angina. Currently, stents are made of metal and stay where they are placed, intact, for life. The problem is that because they are like a mesh, clogs can build up and created blockages - these blockages can occur many years after the stents were placed. These blockages are called 'late stent thrombosis'.
This novel stent, called the BVS everolimus-eluting stent (Bioabsorbable Vascular Solutions, Inc.), is made of a polymer that disappears after three years. The polymer turns into lactic acid. It eventually breaks down into carbon dioxide and water (metabolized through the Krebs cycle).
Dr John Ormiston, team leader, said "You wouldn't want to keep a cast on a broken arm after its mended. In the same way, there is no point keeping a stent in place after the artery has healed. I think we'll look back in 10 years' time and laugh at the idea of putting bits of metal into coronary arteries that stay there for ever."
The researchers say this new stent has many advantages:
-- Lower risk of late stent thrombosis
-- Easier to perform further surgeries on the artery
-- Clearer CT and MRI images because stents are not made of metal
-- As they are flexible, they fit more snugly inside the artery
It is also a drug eluting stent, meaning it releases a drug - its elution period is about 120 days.
The BVS stent had a high success rate in a trial with 30 patients who had single, de novo, native coronary artery lesions. - no major adverse cardiac events were reported during a 30-day follow-up, according to Dr. Ormiston, who works at the Green Lane and Mercy Hospital in Auckland, New Zealand. He said there were no cases of ischemia-driven major adverse cardiac events during the patients' stay in hospital. The procedural success rate was 100%.
Copyright by medicalnewstoday.com
A heart stent is a type of scaffold, or mesh, which is placed in a blocked/narrowed artery to keep it open. Stents are commonly used for heart attack patients, people with a clogged artery, as well as patients with angina. Currently, stents are made of metal and stay where they are placed, intact, for life. The problem is that because they are like a mesh, clogs can build up and created blockages - these blockages can occur many years after the stents were placed. These blockages are called 'late stent thrombosis'.
This novel stent, called the BVS everolimus-eluting stent (Bioabsorbable Vascular Solutions, Inc.), is made of a polymer that disappears after three years. The polymer turns into lactic acid. It eventually breaks down into carbon dioxide and water (metabolized through the Krebs cycle).
Dr John Ormiston, team leader, said "You wouldn't want to keep a cast on a broken arm after its mended. In the same way, there is no point keeping a stent in place after the artery has healed. I think we'll look back in 10 years' time and laugh at the idea of putting bits of metal into coronary arteries that stay there for ever."
The researchers say this new stent has many advantages:
-- Lower risk of late stent thrombosis
-- Easier to perform further surgeries on the artery
-- Clearer CT and MRI images because stents are not made of metal
-- As they are flexible, they fit more snugly inside the artery
It is also a drug eluting stent, meaning it releases a drug - its elution period is about 120 days.
The BVS stent had a high success rate in a trial with 30 patients who had single, de novo, native coronary artery lesions. - no major adverse cardiac events were reported during a 30-day follow-up, according to Dr. Ormiston, who works at the Green Lane and Mercy Hospital in Auckland, New Zealand. He said there were no cases of ischemia-driven major adverse cardiac events during the patients' stay in hospital. The procedural success rate was 100%.
Copyright by medicalnewstoday.com
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