Why we need better drug monitoring
2011-01-11
(Press-News.org) The use of recombinant activated factor 7 (rFVIIa) despite its potential for adverse events displays the serious shortcomings of Canada's current drug surveillance system, according to a commentary published in CMAJ (Canadian Medical Association Journal) (pre-embargo link only) http://www.cmaj.ca/embargo/cmaj101842.pdf.
Off-label use of this therapy — a blood product — was driven by key physician opinion leaders who thought recombinant factor VIIa could be used to treat or prevent bleeding in patients without hemophilia at risk of death. This shows how promising case reports can change practice prematurely before more data is available.
Use of recombinant factor VIIa in patients without hemophilia is expensive, marginally effective and risky.
"Off-label use of drugs can be beneficial, however, without a process for ongoing evaluation, deaths, disabilities and costs may be accruing without being obvious at the bedside," writes Paul Hébert, Editor-in-Chief, CMAJ, with coauthors. "With recombinant factor VIIa, physicians were too eager to believe the anecdotes and did not push for the appropriate studies."
Monitoring drug use as well as safety is complicated and lacks a simple solution, although several changes should be considered. These include improved collaboration between payers and insurers who approve and track usage as well as manufacturers, prioritizing higher risk drugs in an improved drug surveillance system, better evaluation of new drugs and greater surveillance powers for regulatory bodies.
INFORMATION: END
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2011-01-11
A paper published online on January 10 in the Journal of Experimental Medicine reports that retinal ganglion cells—neurons in the eye—are rescued by immune cells that infiltrate the mouse retina after eye injury.
A group led by Michal Schwartz at the Weizmann Institute detected immune cells called macrophages in the retinas of mice that sustained eye injuries a few days prior. Thanks to their expression of an anti-inflammatory protein, these macrophages dampened injury-induced inflammation and protected the retinal ganglion cells from death. Macrophage arrival also awakened ...
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2011-01-11
A team of scientists has created particles that closely mirror some of the key properties of red blood cells, potentially helping pave the way for the development of synthetic blood.
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2011-01-11
TITLE:
A microRNA-dependent program controls p53-independent survival and chemosensitivity in human and murine squamous cell carcinoma
AUTHOR CONTACT:
Leif Ellisen
Massachusetts General Hospital Cancer Center, Boston, MA, USA
Phone: (617)726-4315; Fax: (617)726-8623; E-mail: ellisen@helix.mgh.harvard.edu
View this article at: http://www.jci.org/articles/view/43897?key=34ca4a64f929de6d5fea
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2011-01-11
TITLE:
Generation of hyaline cartilaginous tissue from mouse adult dermal fibroblast culture by defined factors
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Phone: +81-6-6879-3552; Fax: +81-6-6879-3559; E-mail: ntsumaki@dbcb.med.osaka-u.ac.jp
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2011-01-11
EDITOR'S PICK
Cancer cell survival is not miR-ly dependent on p53
Squamous cell carcinoma (SCC) is a common type of skin cancer and remains one of the most resistant to available chemotherapies. Many cancer therapeutic strategies are directed at restoring the function of the tumor suppressor gene p53, because when active, cells are more sensitive to the DNA damage induced by chemotherapy. Other proteins related to p53, including p63 and p73, have also been implicated in cancer and cell sensitivity to chemotherapy. Both p63 and p73 are overexpressed in SCC, and are thought ...
2011-01-11
While wealthier people have chosen alternatives to urban nursing homes, the urban poor still depend on them for long-term care. A new study led by researchers at Brown University finds that option is nevertheless slipping away. Between 1999 and 2008, nursing home closures in the United States were concentrated disproportionately in poor, urban and predominantly minority neighborhoods.
Overall, the United States lost 5 percent, or 96,902, of its total nursing home beds during the decade, as patients with means sought assisted living or other forms of home and community-based ...
2011-01-11
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2011-01-11
A SCUBA expedition in Australia and New Zealand to find the rare embryos of an unusual shark cousin enabled American and British researchers to confirm new developmental similarities between fish and mammals.
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[Press-News.org] Why we need better drug monitoring
