21 April, 2011

Expiration Dates Matter

Communicating Drug Safety Messages

Pharmacists have consistently partnered with FDA on drug safety. Since pharmacists are the most accessible health care professional, they play a key role in educating and discussing FDA's drug safety messages with patients. Moreover, pharmacists are the main reporters of adverse events, incidents of product quality problems, errors in use, and therapeutic failures or inequivalence to FDA's MedWatch program.

NIH statement on World Malaria Day April 25, 2011


Statement of B.F. (Lee) Hall, M.D., Ph.D., and Anthony S. Fauci, M.D., National Institute of Allergy and Infectious Diseases, National Institutes of Health

In commemorating World Malaria Day and reflecting on this year's theme, "Achieving Progress and Impact," we celebrate the important strides made in many regions of the world to control malaria, while acknowledging the enormous challenges that remain.

In 2000, an estimated 350 million to 500 million clinical cases of malaria occurred worldwide and more than 1 million people died from the disease, according to the World Health Organization (WHO). By 2009, there were about 225 million cases of clinical malaria and 781,000 deaths.

Decreases in cases of malaria occurred in all affected regions, with the greatest decline in the number of malaria deaths occurring in Africa. Furthermore, in 2010, WHO certified that two countries, Morocco and Turkmenistan, had eliminated malaria — that is, reduced the incidence of infections in their countries to zero. Although these numbers reflect significant improvements, the global burden of malaria remains far too high and will require sustained and coordinated efforts from the international community to reduce it further.

Today we enter the third year of the Global Malaria Action Plan (GMAP) http://www.rbm.who.int/gmap/gmap.pdf, developed by the Roll Back Malaria (RBM) Partnership, http://www.rollbackmalaria.org/. The GMAP, an international framework for coordinated action against malaria, sets ambitious goals to control, eliminate and eradicate malaria.

The National Institutes of Health is committed to supporting the GMAP. To make continued progress and achieve long-term GMAP goals, we must build a sustainable pipeline of new products, novel interventions and innovative strategies to diagnose, treat and prevent malaria as well as interrupt its transmission. Below we describe examples of significant advances made in these areas during the past year.

The emergence and spread of parasites resistant to conventional anti-malarial drugs threatens treatment efforts. Recently, NIH grantees identified a novel compoundhttp://www.niaid.nih.gov/news/newsreleases/2010/Pages/malariaDrug.aspx that rids mice of malaria-causing parasites with a single oral dose. This compound acts on a novel target in the parasite that may allow it to kill parasites that have developed resistance to other antimalarial drugs. Further studies will determine whether this compound can become a new therapy. Similarly, insecticide resistance can undercut mosquito-control strategies for containing malaria. Although research on insecticides with novel mechanisms of action continues, such compounds, like current insecticides, run the risk of selecting for the emergence and spread of mosquitoes resistant to the new insecticide. Therefore, novel approaches must be pursued.

NIH-funded researchers recently identified a genetically modified fungushttp://www.niaid.nih.gov/news/newsreleases/2011/Pages/MalariaFungi.aspx that blocks development of malaria parasites in the mosquito and thereby interrupts malaria transmission. Because the fungi do not kill the mosquitoes, they would be unlikely to develop resistance. Such fungi could become an important malaria intervention if future studies demonstrate that they are safe and effective.

Within the next few months, we expect to learn the results of a large-scale clinical trial in Africa of a candidate malaria vaccine known as RTS,S. We all hope that an effective vaccine that confers protection against the most deadly type of disease, Plasmodium falciparum malaria, soon will be available. Meanwhile, efforts to develop new and improved malaria vaccines continue globally, with 16 candidates currently in preclinical development and another 23 in clinical trials.

Early this year, we joined with others in announcing a renewed interest in the possible eradication of malaria, as described in the Malaria Eradication Research Agenda (MalERA)http://www.who.int/malaria/elimination/maleraupdate.pdf, the result of a global consultation effort among multiple stakeholders and disciplines. A key message of MalERA is that the tools to eradicate malaria do not exist and must be developed. A major challenge will be to continually assess the changing epidemiology of malaria as control and elimination efforts prove successful to ensure that appropriate tools and interventions are developed and effectively deployed.

To bridge clinical and field research with new laboratory-based methods in immunology, molecular biology and genomics, we at the NIH National Institute of Allergy and Infectious Diseases recently launched a network of International Centers of Excellence for Malaria Researchhttp://www.niaid.nih.gov/news/newsreleases/2010/Pages/MalariaICEMR.aspx. This network, which supports teams of scientists conducting research in more than 20 malaria-endemic countries, will provide new insights from research conducted in the context of rapidly changing malaria epidemiology.

A strong foundation of scientific insight, technological innovation and effective implementation has enabled us to achieve progress and advance several fronts in the fight against malaria. We must sustain this critical foundation as we continue to work together toward our shared goals of global malaria control, elimination and eradication.

For more information on malaria, visit NIAID’s Malaria Web portalhttp://www.niaid.nih.gov/topics/Malaria/Pages/default.aspx.

Lee Hall, M.D., Ph.D., is Chief of the Parasitology and International Programs Branch in the NIAID Division of Microbiology and Infectious Diseases. Anthony S. Fauci, M.D., is Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Maryland.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site athttp://www.niaid.nih.gov

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About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visitwww.nih.gov.

FDA Acts to Reduce Harm from Opioid Drugs

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